CHAMGAP

Medical-grade manuka honey × MGD dry-eye symptoms: added benefit over existing care unverified

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Required evidence, verification status and materials actually read
ItemAVerification statusBReading scopeCReview itemDCurrent findingsEWhy unverifiedFRequired materials and conditionsGFurther research
1 Partly verified Full text not readStored summary read N01 · Evidence conditionWhich symptom question does this evidence check cover?Required
The existing subquestion is improved dry-eye symptoms over existing care. The original explanation that different within-group P values do not establish direct superiority is retained.
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
Whether dry-eye symptoms improve more than with existing care and the scope of added benefit
Material needed: The parent verdict's symptoms and signs are not combined into a single symptom effect; original direct symptom outcomes, controls, denominators and between-group estimates are needed. This records needed materials; no new research was executed.
2 Partly verified Full text not readStored summary read N02 · Evidence conditionWhat is the hierarchy of SPEED and other symptom scales?Required
The supporting trial lists 3-week SPEED, tear film, inflammation and staining as outcomes. The principal trial covered multiple symptoms and signs.
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
The main symptom scale, version, time point, baseline and between-group results
Material needed: SPEED is not duplicated across all symptoms and signs; scales, time points, prespecified plans, all symptom tables and denominators remain unverified. This records needed materials; no new research was executed.
3 Partly verified Full text not readStored summary read N03 · Evidence conditionWhat was the SPEED change in the honey-drop group?Required
The supporting trial reported a within-group SPEED change of 2.53 points, P=.006, in the honey group. This is a before-and-after record in that group.
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
The honey group's 3-week SPEED change, original analysis and denominator
Material needed: It is not converted into added benefit over existing care; baseline and final values, models, variance, denominators and direct between-group results remain unverified. No new difference or CI is calculated. This records needed materials; no new research was executed.
4 Partly verified Full text not readStored summary read N04 · Evidence conditionHow is the regular-lubricant group's change distinguished?Required
The original control within-group change was 1.087 points, P=.183. Nonsignificance in control is not a test of honey-group superiority.
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
The regular-lubricant group's 3-week SPEED change and comparison conditions
Material needed: Control ingredients, within-group tables, denominators, dispersion and between-group contrasts remain unverified. 1.087 is not subtracted from 2.53 to create a new added effect. This records needed materials; no new research was executed.
5 Partly verified Full text not readStored summary read N05 · Evidence conditionAre P=.006 and P=.183 a between-group superiority test?Required
The original account explicitly states that the different within-group P values are not a superiority test.
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
Direct comparison of the changes, between-group P values and CIs
Material needed: A difference in P values is not treated as a significant difference in effects; direct between-group estimates, CIs, denominators, models, multiplicity and prespecified plans remain unverified. This records needed materials; no new research was executed.
6 Unverified Full text not readStored summary read N06 · Evidence conditionAre the direct between-group symptom effect and 95% CI verified?Required
The stored summary records that the supporting trial's abstract did not present a direct between-group symptom effect.
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
The added symptom effect and its original uncertainty
Material needed: That record about the original abstract is distinguished from external materials being unread in this work. Exact between-group results, CIs, P values, denominators, adjustment and variance remain unverified, without conversion into no effect or established efficacy. This records needed materials; no new research was executed.
7 Partly verified Full text not readStored summary read N07 · Evidence conditionCan overall improvement in 114 participants and 3 groups be assigned to the product?Required
All groups in the principal trial improved and used common warm compresses, lid massage and preservative-free lubricant.
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
Added symptom benefit over common care and group-specific results
Material needed: Overall improvement is not assigned to honey as an ingredient; group-specific symptoms, baselines, time points, denominators, common-care adherence and direct between-group contrasts remain unverified. This records needed materials; no new research was executed.
8 Partly verified Full text not readStored summary read N08 · Evidence conditionAre 16% drops and 98% gel the same formulation?Required
The original record distinguishes 16% drops and 98% gel as different formulations.
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
Formulation-specific symptom effects, administered amounts, frequency and control
Material needed: An effect from one formulation is not copied to or pooled with another. Formulation-specific products, administered amounts, frequency, symptom scales, denominators, time points and between-group effects remain unverified. This records needed materials; no new research was executed.
9 Partly verified Full text not readStored summary read N09 · Evidence conditionAre selected P values for clinical signs symptom effects?Supplementary
In the principal trial, staining with drops P=.035 and gel meibum quality P=.005 and gland expressibility P=.042 were signals in selected signs.
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
The direct relevance of staining and meibomian measures to symptom outcomes
Material needed: These values are not converted into SPEED or patient symptom-effect estimates. Original sign and symptom tables, hierarchy, denominators, formulation and time-point matching remain unverified. This records needed materials; no new research was executed.
10 Partly verified Full text not readStored summary read N10 · Evidence conditionDoes assessor masking also mean participant masking?Required
The supporting trial's original design was an assessor-masked randomized trial.
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
The roles of assessor masking and symptom reporting and measurement
Material needed: Double masking of participants and treatment providers or exclusion of expectancy effects is not newly verified. Allocation, concealment, masking roles, symptom responses, control appearance, stinging and assessment methods remain unverified. This records needed materials; no new research was executed.
11 Partly verified Full text not readStored summary read N11 · Evidence conditionWhat are the limitations of open treatment and multiple outcomes?Required
The principal trial used an open 3-group randomized design and retained multiple symptoms and signs.
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
The principal trial's open 3-group methods, prespecified symptom outcomes and all results
Material needed: Selected findings are not expanded into superiority for all symptoms. Original methods, registration, protocols, analysis plans, all time points and multiplicity plans remain unverified; no new official assessment is created. This records needed materials; no new research was executed.
12 Partly verified Full text not readStored summary read N12 · Evidence conditionAre 3 weeks and the principal 8 weeks the same duration?Required
The principal direct trial's 8 weeks and the supporting trial's 3-week SPEED measure are distinguished in the original account.
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
The supporting trial's 3 weeks, the principal trial's 8 weeks, and long-term and post-stopping results
Material needed: One trial's time point is not assigned to another trial or to long-term durability. Report-specific schedules, administration, adherence, endpoint denominators and long-term and post-stopping material remain unverified. This records needed materials; no new research was executed.
13 Partly verified Full text not readStored summary read N13 · Evidence conditionAre symptom importance, responders and lubricant use verified?Supplementary
The original outcome list includes symptoms and lubricant use, but prespecified importance, responders and exact between-group medication use are not detailed.
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
Direct material on SPEED importance, responders, lubricant and rescue-medication use
Material needed: Thresholds, responders, medication use, denominators, CIs and prespecified hierarchy remain unverified. Within-group means are not converted into treatment-success rates or medication replacement. This records needed materials; no new research was executed.
14 Partly verified Full text not readStored summary read N14 · Evidence conditionHow are medical-grade sterile products distinguished from food honey?Required
The original record concerns ophthalmic medical-grade products, not evidence for food-grade manuka honey or homemade dilution. Concentration differs from actual instilled amount and frequency.
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
Manufacture, quality and actual administration of medical-grade 16% drops and 98% gel
Material needed: Product, sterility, ingredients, manufacture, dose, frequency and administration records remain unverified in detail. Medical-grade product records are not expanded into effects of food-grade or nonsterile products. This records needed materials; no new research was executed.
15 Partly verified Full text not readStored summary read N15 · Evidence conditionWhat was added to common lid care?Required
In 2017, all groups used common warm compresses, lid massage and preservative-free lubricant. The comparison added medical-grade honey products to that care.
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
Warm compresses, massage, preservative-free lubricant and formulation-specific additional care
Material needed: It is not converted into evidence for stopping care or standalone treatment. Common-care rules, adherence, additional and rescue medications, formulation-specific matching and changes remain unverified. This records needed materials; no new research was executed.
16 Partly verified Full text not readStored summary read N16 · Evidence conditionAre MGD diagnosis and sample size the same information?Required
The parent question concerns evaporative dry eye from meibomian gland dysfunction. 114 participants is the original sample-size label.
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
Diagnosis, severity, baseline status and group-specific eligibility in evaporative dry eye
Material needed: Sample size does not replace diagnostic or eligibility criteria. Diagnosis, severity, baseline symptoms and signs, age, comorbidities and group-specific inclusion and exclusion remain unverified. This records needed materials; no new research was executed.
17 Partly verified Full text not readStored summary read N17 · Evidence conditionWhat are the symptom denominators in 114 participants and 3 groups?Required
The principal trial's sample was 114 participants and its design was an open 3-group randomized trial.
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
Group allocation, completion, analysis and endpoint-specific eye and patient denominators
Material needed: Group allocation, completion, formulations, care groups, endpoints, time points, bilateral-eye and patient denominators and exclusions remain unverified. Denominators absent from the original are not created. This records needed materials; no new research was executed.
18 Partly verified Full text not readStored summary read N18 · Evidence conditionWhat denominators are 59 randomized and 55 completed?Required
The supporting trial originally recorded 59 randomized and 55 completed. These values describe separate stages.
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
Supporting-trial allocation, completion, analysis and group, eye and patient endpoint denominators
Material needed: Attrition counts or group-specific and endpoint-specific analysis denominators are not calculated or established. Group flow, reasons, time points and eye and patient denominators remain unverified. This records needed materials; no new research was executed.
19 Unverified Full text not readStored summary read N19 · Evidence conditionWhat is the impact of missingness, attrition and measurement exclusions?Required
Overall sample and completion records exist, but endpoint-specific missingness, attrition reasons and analysis conditions are not detailed.
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
Group flow, missing symptom outcomes, analysis populations and sensitivity analyses
Material needed: Unread external material is not converted into absence of missingness. Missingness, stopping, exclusions, ITT and completer analyses, missing-data handling, sensitivity and group and eye matching remain unverified. This records needed materials; no new research was executed.
20 Unverified Full text not readStored summary read N20 · Evidence conditionWhat were the baseline adjustment, change and testing conditions?Required
Original P values and selected changes are retained, but detailed adjustment, variance, time points, denominators and effects of interest remain unread in external originals.
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
The effect of interest, baseline adjustment, change and final values, and variance
Material needed: Original analysis plans, statistical tables, baseline and changes, within-eye and within-person correlation, models and CIs remain unverified. New effects or CIs are not back-calculated. This records needed materials; no new research was executed.
21 Partly verified Full text not readStored summary read N21 · Evidence conditionDoes a registration number also verify prespecified plans?Required
Registration was unverified for the principal trial, while NCT04457648 was recorded for the supporting trial.
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
Registration, history, primary outcomes, changes and original plans for both trials
Material needed: The number's existence is not promoted into registration reading in this work, prespecification, hierarchy at all time points or plan adherence. Official registration history, protocols and analysis plans were unread in this work. This records needed materials; no new research was executed.
22 Partly verified Full text not readStored summary read N22 · Evidence conditionDo parent and subquestions share the same reports?Required
The parent and subquestions share the same Albietz 2017 and Wong 2021 reports.
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
Report, trial and participant links between the symptom question and other questions
Material needed: Sheet counts are not counted as new studies or independent replications. Report, trial, registration, sample, institution, timing and additional-report matching and unique trial and participant totals remain unverified. This records needed materials; no new research was executed.
23 Partly verified Full text not readStored summary read N23 · Evidence conditionIs independent replication across teams, products and formulations verified?Supplementary
The bibliographies of both reports retain an Albietz author and the specific Optimel product context.
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
Unique trials and independent teams for the same symptoms, formulation, population, comparison and time point
Material needed: Different reports or assessor masking alone do not newly establish independent teams or replication under the same conditions. Team, institution, product, funding, participant, effect and denominator matching remain unverified. This records needed materials; no new research was executed.
24 Partly verified Full text not readStored summary read N24 · Evidence conditionHow much is known about product provision and company involvement?Required
The principal trial records Optimel product provision and related involvement; the supporting trial records a specific Optimel product, provision and author conflict disclosure.
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
Trial-specific funding, product support, employee authors and conflicts
Material needed: Unrecorded funding, employee relationships, analysis and publication roles remain unverified. Product provision is not treated as verification of every involvement route or as absence of independence. This records needed materials; no new research was executed.
25 Partly verified Full text not readStored summary read N25 · Evidence conditionWhat is the scope of reported stinging and redness?Supplementary
The original record reports temporary stinging and redness and cautions that initial symptoms are possible even with medical-grade formulations.
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
Medical-grade product adverse reactions, collection methods, stopping and controls
Material needed: Event counts, incidence or new causality are not created. Collection methods, group and formulation-specific events, severity, timing, stopping, missingness and controls remain unverified. This records needed materials; no new research was executed.
26 Unverified Full text not readStored summary read N26 · Evidence conditionWhat are the eye and patient harm denominators and exposures?Supplementary
114 participants, 59 randomized and 55 completed do not verify safety denominators. Concentrations, formulations, 3 and 8 weeks and common care are not combined as the same harm exposure.
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
Safety populations, eyes, patients, formulations, durations and actual instillation exposure
Material needed: Safety denominators, actual instillation, group, eye and formulation-specific events, stopping, exposure and controls remain unverified. Incidence is not calculated. This records needed materials; no new research was executed.
27 Partly verified Full text not readStored summary read N27 · Evidence conditionAre food or nonsterile risks distinguished from medical-grade product reactions?Supplementary
The original caution distinguishes infection and corneal-injury risks with food-grade, nonsterile and homemade dilutions from initial stinging and redness with medical-grade products.
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
Manufacture, sterility, baseline eye conditions, other causes and clinical course
Material needed: The food-honey self-instillation question is distinguished and no new case is created. Products, baseline eye conditions, concurrent use, event timing, alternative causes, controls and course remain unverified; no new harm causality is judged. This records needed materials; no new research was executed.
28 Unverified Full text not readStored summary read N28 · Evidence conditionAre long-term, rare and vulnerable-population harms verified?Supplementary
Small short-term trials of specific products and descriptions of temporary reactions do not verify long-term, rare or vulnerable-population safety.
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
Long exposure, independent harm reports, vulnerable populations and follow-up
Material needed: Long follow-up, independent harm reports, vulnerable populations, exposure, denominators, concurrent use and course remain unverified. No external search or new harm judgment was performed in this work. This records needed materials; no new research was executed.
29 Partly verified Full text not readStored summary read N29 · Evidence conditionHow does stored-summary reading differ from reading external originals?Required
The complete parent Korean and English summary, reports and citations were read. PubMed URLs and registration numbers are existing records; external abstracts, full texts, registration, protocols and analysis plans were unread in this work.
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
The complete stored summary and the reading scope for external abstracts, full texts, registration and plans
Material needed: URLs, numbers and historical verification wording do not establish current reading, successful access or fulfilled conditions. External detailed-material availability, acquisition and actual reading remain separately unverified. This records needed materials; no new research was executed.
30 Partly verified Full text not readStored summary read N30 · Evidence conditionWhat do selected C, parent C46, dates and empty values record?Required
The selected grade is C, with no individual score, status or axes fields. Parent C46, caution, axes, Korean and English records, 2026-09-07 and empty correction and deliberation records are preserved separately.
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
The selected grade, absent individual score, parent axes, evidence date and corrections
Material needed: The parent's 46 points are not assigned as a subclaim score, and the historical evidence date is not changed into a new search, external reading or completed-review date. New material, condition revisions and verdict changes are separate events. This records needed materials; no new research was executed.
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30 itemsWhat the statuses mean

Assessment scope

Stored-material review date
Not recorded
Original evidence cut-off
2026-09-07
Scope actually checked
Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean
This is the date the stored materials were checked, not the date of a new search of the clinical literature.
Population
Evaporative dry eye from meibomian gland dysfunction. Detailed diagnosis, severity, baseline status, eligibility and group composition remain unverified.
Ingredient, formulation and route
Medical-grade 16% manuka-honey drops or 98% gel were added to existing lid care. Formulations are distinguished from each other and from food-grade or nonsterile products.
Dose
16% and 98% are concentrations of different formulations. Actual instilled amount, frequency, adherence and exposure remain unverified; concentration is not converted into administered dose.
Comparator
Common warm compresses, lid massage and preservative-free lubricant in the 2017 trial are distinguished from comparison with regular lubricant in the 2021 trial. Details of matched group care and changes remain unverified.
Measured outcome
3-week SPEED symptoms are distinguished from selected staining and meibomian signs. Different within-group P values do not replace direct between-group symptom effects.
Duration
The principal direct trial over 8 weeks is distinguished from the supporting symptom trial over 3 weeks. Long-term and post-stopping effects and harms remain unverified.
Questions outside this scope
Selected C and absent individual score are distinguished from parent C46, selected-signs C and food-honey self-instillation F. Parent score or axes are not newly filled into the subquestion.; 16% drops and 98% gel are not combined, and medical-grade sterile products are not expanded into evidence for food-grade, nonsterile or homemade-dilution instillation.; SPEED 2.53 points P=.006 and 1.087 points P=.183 are original within-group records. New differences, between-group superiority or CIs are not calculated.; Selected staining P=.035, meibum quality P=.005 and gland expressibility P=.042 signals are not converted into patient symptom effects.; 114 participants and 59 randomized with 55 completed are distinguished without calculating new attrition counts, group, eye, patient or safety denominators, or incidence.; Shared reports are not counted as new independent replication for each question. Short-term symptoms and signs are not expanded into long-term recovery, treatment replacement or overall safety.

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

R01 · Albietz JM·Lenton LM. 2017

PubMed

Material type
Open 3-group randomized trial
Materials actually read
The complete stored parent Korean and English summary, original reports and citations were read. External abstracts, full texts, registration, protocols and analysis plans were unread in this work.
Findings recorded in the stored summary
The original comparison in 114 participants added 16% drops or 98% gel to common care. All groups improved; selected sign signals included staining with drops P=.035 and gel meibum quality P=.005 and gland expressibility P=.042.
Record level
Selected formulation-specific signs are not converted into direct symptom superiority. The original principal duration is 8 weeks; group-specific symptom effects, precision, eye and patient denominators and prespecified hierarchy remain unverified.
Study overlap and independent replication
Parent 3016 and the symptom and selected-sign questions share 2 reports, Albietz 2017 and Wong 2021. Shared authors and the specific Optimel product context are retained, while exact sample overlap, unique trial and participant totals and independent replication remain unverified.
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
Stored existing review summaryPreserved copy of the complete parent-verdict stored summaryStored summarySummary readPMID28585260, DOI10.1111/cxo.12524 and the original record of Optimel product provision and related involvement are retained. Registration details, product contracts, funding and author roles are unread externally; unverified information is not converted into absence. The stored-summary material date 2026-10-06T13:02:14.255886+09:00 is an original production record; unread external material dates are empty. The historical evidence date 2026-09-07 is distinguished from this publication, external reading or completed clinical review.
External abstractOriginal bibliographic link or needed material; external public availability/access status unverifiedUnread; access not attemptedNot readPMID28585260, DOI10.1111/cxo.12524 and the original record of Optimel product provision and related involvement are retained. Registration details, product contracts, funding and author roles are unread externally; unverified information is not converted into absence. The stored-summary material date 2026-10-06T13:02:14.255886+09:00 is an original production record; unread external material dates are empty. The historical evidence date 2026-09-07 is distinguished from this publication, external reading or completed clinical review.
External full textOriginal bibliographic link or needed material; external public availability/access status unverifiedUnread; access not attemptedNot readPMID28585260, DOI10.1111/cxo.12524 and the original record of Optimel product provision and related involvement are retained. Registration details, product contracts, funding and author roles are unread externally; unverified information is not converted into absence. The stored-summary material date 2026-10-06T13:02:14.255886+09:00 is an original production record; unread external material dates are empty. The historical evidence date 2026-09-07 is distinguished from this publication, external reading or completed clinical review.
Registration materialOriginal bibliographic link or needed material; external public availability/access status unverifiedUnread; access not attemptedNot readPMID28585260, DOI10.1111/cxo.12524 and the original record of Optimel product provision and related involvement are retained. Registration details, product contracts, funding and author roles are unread externally; unverified information is not converted into absence. The stored-summary material date 2026-10-06T13:02:14.255886+09:00 is an original production record; unread external material dates are empty. The historical evidence date 2026-09-07 is distinguished from this publication, external reading or completed clinical review.
Protocol and analysis planOriginal bibliographic link or needed material; external public availability/access status unverifiedUnread; access not attemptedNot readPMID28585260, DOI10.1111/cxo.12524 and the original record of Optimel product provision and related involvement are retained. Registration details, product contracts, funding and author roles are unread externally; unverified information is not converted into absence. The stored-summary material date 2026-10-06T13:02:14.255886+09:00 is an original production record; unread external material dates are empty. The historical evidence date 2026-09-07 is distinguished from this publication, external reading or completed clinical review.

R02 · Wong D et al. 2021

PubMed

Material type
Assessor-masked randomized trial
Materials actually read
The complete stored parent Korean and English summary, original reports and citations were read. External abstracts, full texts, registration, protocols and analysis plans were unread in this work.
Findings recorded in the stored summary
59 randomized and 55 completed were recorded, with 3-week within-group SPEED changes of 2.53 points P=.006 for honey drops and 1.087 points P=.183 for regular lubricant. The stored summary states that the abstract did not present a direct between-group symptom effect.
Record level
Different within-group P values are not a superiority test. Assessor masking is not promoted into participant or treatment-provider masking. New differences in changes, CIs, attrition counts or safety denominators are not calculated.
Study overlap and independent replication
Parent 3016 and the symptom and selected-sign questions share 2 reports, Albietz 2017 and Wong 2021. Shared authors and the specific Optimel product context are retained, while exact sample overlap, unique trial and participant totals and independent replication remain unverified.
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
Stored existing review summaryPreserved copy of the complete parent-verdict stored summaryStored summarySummary readPMID33419788, DOI10.1136/bjophthalmol-2020-317506, NCT04457648, specific Optimel product provision and author conflict disclosure are retained. The number does not establish registration reading in this work, prespecification or plan adherence; disclosure details are unread. The stored-summary material date 2026-10-06T13:02:14.255886+09:00 is an original production record; unread external material dates are empty. The historical evidence date 2026-09-07 is distinguished from this publication, external reading or completed clinical review.
External abstractOriginal bibliographic link or needed material; external public availability/access status unverifiedUnread; access not attemptedNot readPMID33419788, DOI10.1136/bjophthalmol-2020-317506, NCT04457648, specific Optimel product provision and author conflict disclosure are retained. The number does not establish registration reading in this work, prespecification or plan adherence; disclosure details are unread. The stored-summary material date 2026-10-06T13:02:14.255886+09:00 is an original production record; unread external material dates are empty. The historical evidence date 2026-09-07 is distinguished from this publication, external reading or completed clinical review.
External full textOriginal bibliographic link or needed material; external public availability/access status unverifiedUnread; access not attemptedNot readPMID33419788, DOI10.1136/bjophthalmol-2020-317506, NCT04457648, specific Optimel product provision and author conflict disclosure are retained. The number does not establish registration reading in this work, prespecification or plan adherence; disclosure details are unread. The stored-summary material date 2026-10-06T13:02:14.255886+09:00 is an original production record; unread external material dates are empty. The historical evidence date 2026-09-07 is distinguished from this publication, external reading or completed clinical review.
Registration materialOriginal bibliographic link or needed material; external public availability/access status unverifiedUnread; access not attemptedNot readPMID33419788, DOI10.1136/bjophthalmol-2020-317506, NCT04457648, specific Optimel product provision and author conflict disclosure are retained. The number does not establish registration reading in this work, prespecification or plan adherence; disclosure details are unread. The stored-summary material date 2026-10-06T13:02:14.255886+09:00 is an original production record; unread external material dates are empty. The historical evidence date 2026-09-07 is distinguished from this publication, external reading or completed clinical review.
Protocol and analysis planOriginal bibliographic link or needed material; external public availability/access status unverifiedUnread; access not attemptedNot readPMID33419788, DOI10.1136/bjophthalmol-2020-317506, NCT04457648, specific Optimel product provision and author conflict disclosure are retained. The number does not establish registration reading in this work, prespecification or plan adherence; disclosure details are unread. The stored-summary material date 2026-10-06T13:02:14.255886+09:00 is an original production record; unread external material dates are empty. The historical evidence date 2026-09-07 is distinguished from this publication, external reading or completed clinical review.

Report counts versus independent study counts

Parent 3016 and the symptom and selected-sign questions share 2 reports, Albietz 2017 and Wong 2021. Shared authors and the specific Optimel product context are retained, while exact sample overlap, unique trial and participant totals and independent replication remain unverified.

Review criteria

Version 1.0 · Criteria record date 2026-10-06. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · Which symptom question does this evidence check cover?
Required materials and conditions
Whether dry-eye symptoms improve more than with existing care and the scope of added benefit
Conditions for verification
Original material on Whether dry-eye symptoms improve more than with existing care and the scope of added benefit must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Requirement and applicability
Required
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Why this condition is needed
Material on Whether dry-eye symptoms improve more than with existing care and the scope of added benefit is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.
N02 · What is the hierarchy of SPEED and other symptom scales?
Required materials and conditions
The main symptom scale, version, time point, baseline and between-group results
Conditions for verification
Original material on The main symptom scale, version, time point, baseline and between-group results must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Requirement and applicability
Required
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Why this condition is needed
Material on The main symptom scale, version, time point, baseline and between-group results is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.
N03 · What was the SPEED change in the honey-drop group?
Required materials and conditions
The honey group's 3-week SPEED change, original analysis and denominator
Conditions for verification
Original material on The honey group's 3-week SPEED change, original analysis and denominator must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Requirement and applicability
Required
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Why this condition is needed
Material on The honey group's 3-week SPEED change, original analysis and denominator is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.
N04 · How is the regular-lubricant group's change distinguished?
Required materials and conditions
The regular-lubricant group's 3-week SPEED change and comparison conditions
Conditions for verification
Original material on The regular-lubricant group's 3-week SPEED change and comparison conditions must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Requirement and applicability
Required
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Why this condition is needed
Material on The regular-lubricant group's 3-week SPEED change and comparison conditions is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.
N05 · Are P=.006 and P=.183 a between-group superiority test?
Required materials and conditions
Direct comparison of the changes, between-group P values and CIs
Conditions for verification
Original material on Direct comparison of the changes, between-group P values and CIs must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Requirement and applicability
Required
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Why this condition is needed
Material on Direct comparison of the changes, between-group P values and CIs is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.
N06 · Are the direct between-group symptom effect and 95% CI verified?
Required materials and conditions
The added symptom effect and its original uncertainty
Conditions for verification
Original material on The added symptom effect and its original uncertainty must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Requirement and applicability
Required
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Why this condition is needed
Material on The added symptom effect and its original uncertainty is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.
N07 · Can overall improvement in 114 participants and 3 groups be assigned to the product?
Required materials and conditions
Added symptom benefit over common care and group-specific results
Conditions for verification
Original material on Added symptom benefit over common care and group-specific results must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Requirement and applicability
Required
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Why this condition is needed
Material on Added symptom benefit over common care and group-specific results is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.
N08 · Are 16% drops and 98% gel the same formulation?
Required materials and conditions
Formulation-specific symptom effects, administered amounts, frequency and control
Conditions for verification
Original material on Formulation-specific symptom effects, administered amounts, frequency and control must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Requirement and applicability
Required
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Why this condition is needed
Material on Formulation-specific symptom effects, administered amounts, frequency and control is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.
N09 · Are selected P values for clinical signs symptom effects?
Required materials and conditions
The direct relevance of staining and meibomian measures to symptom outcomes
Conditions for verification
Original material on The direct relevance of staining and meibomian measures to symptom outcomes must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Requirement and applicability
Supplementary
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Why this condition is needed
Material on The direct relevance of staining and meibomian measures to symptom outcomes is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.
N10 · Does assessor masking also mean participant masking?
Required materials and conditions
The roles of assessor masking and symptom reporting and measurement
Conditions for verification
Original material on The roles of assessor masking and symptom reporting and measurement must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Requirement and applicability
Required
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Why this condition is needed
Material on The roles of assessor masking and symptom reporting and measurement is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.
N11 · What are the limitations of open treatment and multiple outcomes?
Required materials and conditions
The principal trial's open 3-group methods, prespecified symptom outcomes and all results
Conditions for verification
Original material on The principal trial's open 3-group methods, prespecified symptom outcomes and all results must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Requirement and applicability
Required
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Why this condition is needed
Material on The principal trial's open 3-group methods, prespecified symptom outcomes and all results is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.
N12 · Are 3 weeks and the principal 8 weeks the same duration?
Required materials and conditions
The supporting trial's 3 weeks, the principal trial's 8 weeks, and long-term and post-stopping results
Conditions for verification
Original material on The supporting trial's 3 weeks, the principal trial's 8 weeks, and long-term and post-stopping results must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Requirement and applicability
Required
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Why this condition is needed
Material on The supporting trial's 3 weeks, the principal trial's 8 weeks, and long-term and post-stopping results is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.
N13 · Are symptom importance, responders and lubricant use verified?
Required materials and conditions
Direct material on SPEED importance, responders, lubricant and rescue-medication use
Conditions for verification
Original material on Direct material on SPEED importance, responders, lubricant and rescue-medication use must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Requirement and applicability
Supplementary
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Why this condition is needed
Material on Direct material on SPEED importance, responders, lubricant and rescue-medication use is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.
N14 · How are medical-grade sterile products distinguished from food honey?
Required materials and conditions
Manufacture, quality and actual administration of medical-grade 16% drops and 98% gel
Conditions for verification
Original material on Manufacture, quality and actual administration of medical-grade 16% drops and 98% gel must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Requirement and applicability
Required
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Why this condition is needed
Material on Manufacture, quality and actual administration of medical-grade 16% drops and 98% gel is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.
N15 · What was added to common lid care?
Required materials and conditions
Warm compresses, massage, preservative-free lubricant and formulation-specific additional care
Conditions for verification
Original material on Warm compresses, massage, preservative-free lubricant and formulation-specific additional care must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Requirement and applicability
Required
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Why this condition is needed
Material on Warm compresses, massage, preservative-free lubricant and formulation-specific additional care is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.
N16 · Are MGD diagnosis and sample size the same information?
Required materials and conditions
Diagnosis, severity, baseline status and group-specific eligibility in evaporative dry eye
Conditions for verification
Original material on Diagnosis, severity, baseline status and group-specific eligibility in evaporative dry eye must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Requirement and applicability
Required
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Why this condition is needed
Material on Diagnosis, severity, baseline status and group-specific eligibility in evaporative dry eye is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.
N17 · What are the symptom denominators in 114 participants and 3 groups?
Required materials and conditions
Group allocation, completion, analysis and endpoint-specific eye and patient denominators
Conditions for verification
Original material on Group allocation, completion, analysis and endpoint-specific eye and patient denominators must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Requirement and applicability
Required
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Why this condition is needed
Material on Group allocation, completion, analysis and endpoint-specific eye and patient denominators is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.
N18 · What denominators are 59 randomized and 55 completed?
Required materials and conditions
Supporting-trial allocation, completion, analysis and group, eye and patient endpoint denominators
Conditions for verification
Original material on Supporting-trial allocation, completion, analysis and group, eye and patient endpoint denominators must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Requirement and applicability
Required
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Why this condition is needed
Material on Supporting-trial allocation, completion, analysis and group, eye and patient endpoint denominators is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.
N19 · What is the impact of missingness, attrition and measurement exclusions?
Required materials and conditions
Group flow, missing symptom outcomes, analysis populations and sensitivity analyses
Conditions for verification
Original material on Group flow, missing symptom outcomes, analysis populations and sensitivity analyses must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Requirement and applicability
Required
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Why this condition is needed
Material on Group flow, missing symptom outcomes, analysis populations and sensitivity analyses is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.
N20 · What were the baseline adjustment, change and testing conditions?
Required materials and conditions
The effect of interest, baseline adjustment, change and final values, and variance
Conditions for verification
Original material on The effect of interest, baseline adjustment, change and final values, and variance must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Requirement and applicability
Required
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Why this condition is needed
Material on The effect of interest, baseline adjustment, change and final values, and variance is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.
N21 · Does a registration number also verify prespecified plans?
Required materials and conditions
Registration, history, primary outcomes, changes and original plans for both trials
Conditions for verification
Original material on Registration, history, primary outcomes, changes and original plans for both trials must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Requirement and applicability
Required
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Why this condition is needed
Material on Registration, history, primary outcomes, changes and original plans for both trials is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.
N22 · Do parent and subquestions share the same reports?
Required materials and conditions
Report, trial and participant links between the symptom question and other questions
Conditions for verification
Original material on Report, trial and participant links between the symptom question and other questions must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Requirement and applicability
Required
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Why this condition is needed
Material on Report, trial and participant links between the symptom question and other questions is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.
N23 · Is independent replication across teams, products and formulations verified?
Required materials and conditions
Unique trials and independent teams for the same symptoms, formulation, population, comparison and time point
Conditions for verification
Original material on Unique trials and independent teams for the same symptoms, formulation, population, comparison and time point must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Requirement and applicability
Supplementary
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Why this condition is needed
Material on Unique trials and independent teams for the same symptoms, formulation, population, comparison and time point is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.
N24 · How much is known about product provision and company involvement?
Required materials and conditions
Trial-specific funding, product support, employee authors and conflicts
Conditions for verification
Original material on Trial-specific funding, product support, employee authors and conflicts must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Requirement and applicability
Required
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Why this condition is needed
Material on Trial-specific funding, product support, employee authors and conflicts is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.
N25 · What is the scope of reported stinging and redness?
Required materials and conditions
Medical-grade product adverse reactions, collection methods, stopping and controls
Conditions for verification
Original material on Medical-grade product adverse reactions, collection methods, stopping and controls must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Requirement and applicability
Supplementary
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Why this condition is needed
Material on Medical-grade product adverse reactions, collection methods, stopping and controls is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.
N26 · What are the eye and patient harm denominators and exposures?
Required materials and conditions
Safety populations, eyes, patients, formulations, durations and actual instillation exposure
Conditions for verification
Original material on Safety populations, eyes, patients, formulations, durations and actual instillation exposure must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Requirement and applicability
Supplementary
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Why this condition is needed
Material on Safety populations, eyes, patients, formulations, durations and actual instillation exposure is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.
N27 · Are food or nonsterile risks distinguished from medical-grade product reactions?
Required materials and conditions
Manufacture, sterility, baseline eye conditions, other causes and clinical course
Conditions for verification
Original material on Manufacture, sterility, baseline eye conditions, other causes and clinical course must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Requirement and applicability
Supplementary
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Why this condition is needed
Material on Manufacture, sterility, baseline eye conditions, other causes and clinical course is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.
N28 · Are long-term, rare and vulnerable-population harms verified?
Required materials and conditions
Long exposure, independent harm reports, vulnerable populations and follow-up
Conditions for verification
Original material on Long exposure, independent harm reports, vulnerable populations and follow-up must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Requirement and applicability
Supplementary
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Why this condition is needed
Material on Long exposure, independent harm reports, vulnerable populations and follow-up is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.
N29 · How does stored-summary reading differ from reading external originals?
Required materials and conditions
The complete stored summary and the reading scope for external abstracts, full texts, registration and plans
Conditions for verification
Original material on The complete stored summary and the reading scope for external abstracts, full texts, registration and plans must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Requirement and applicability
Required
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Why this condition is needed
Material on The complete stored summary and the reading scope for external abstracts, full texts, registration and plans is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.
N30 · What do selected C, parent C46, dates and empty values record?
Required materials and conditions
The selected grade, absent individual score, parent axes, evidence date and corrections
Conditions for verification
Original material on The selected grade, absent individual score, parent axes, evidence date and corrections must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Requirement and applicability
Required
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Why this condition is needed
Material on The selected grade, absent individual score, parent axes, evidence date and corrections is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.
Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle
Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review
Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.

M04 · Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle
Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review
Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.

M08 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle
Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review
Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.

M15 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle
Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review
Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.

M19 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle
Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review
Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.
What the statuses mean
Partly verified
Partial information from the stored summary is linked; detailed originals and content review remain incomplete.
Unverified
Required details cannot be established within the preserved scope. This does not establish absence of effects or studies, or safety.
Review incomplete
Review of existing content remains incomplete.
Met
This state is used only within the relevant conditions after material verification and content review. It was not automatically assigned in this work.
Not reported
Unreported within material actually read. Unread external material is not relabeled as unreported.
Inaccessible
This means actual access failure. External access was not attempted in this work, so this state was not assigned.
Not applicable
Used only with an application exception and reason based on the question scope.
Conflicting data
This requires actual comparison of materials; no new conflict judgment was made in this work.
Insufficient evidence for the conditions
This indicates gaps in additional material for the selected conditions. Unread material as a whole is not converted into an efficacy grade.

Change history

2026-10-21 · Public page/material version 1.0

Public-facing views and materials were prepared from the existing 30 items. No new clinical search, verification-status change or scoring was performed.

The stored-material review date (Not recorded) and original evidence cut-off (2026-09-07) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

N01 · Which symptom question does this evidence check cover?

Current findings
The existing subquestion is improved dry-eye symptoms over existing care. The original explanation that different within-group P values do not establish direct superiority is retained.
Verification status
Partly verified
Materials actually read
Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
Reason for missing information
The parent verdict's symptoms and signs are not combined into a single symptom effect; original direct symptom outcomes, controls, denominators and between-group estimates are needed.
Required materials and conditions
Whether dry-eye symptoms improve more than with existing care and the scope of added benefit
Materials to obtain first
The parent verdict's symptoms and signs are not combined into a single symptom effect; original direct symptom outcomes, controls, denominators and between-group estimates are needed.
Further research
Material needed: The parent verdict's symptoms and signs are not combined into a single symptom effect; original direct symptom outcomes, controls, denominators and between-group estimates are needed. This records needed materials; no new research was executed.
Remaining uncertainty
Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.
Conditions for verification
Original material on Whether dry-eye symptoms improve more than with existing care and the scope of added benefit must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Why this condition is needed
Material on Whether dry-eye symptoms improve more than with existing care and the scope of added benefit is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.

Related sources R01 R02

N02 · What is the hierarchy of SPEED and other symptom scales?

Current findings
The supporting trial lists 3-week SPEED, tear film, inflammation and staining as outcomes. The principal trial covered multiple symptoms and signs.
Verification status
Partly verified
Materials actually read
Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
Reason for missing information
SPEED is not duplicated across all symptoms and signs; scales, time points, prespecified plans, all symptom tables and denominators remain unverified.
Required materials and conditions
The main symptom scale, version, time point, baseline and between-group results
Materials to obtain first
SPEED is not duplicated across all symptoms and signs; scales, time points, prespecified plans, all symptom tables and denominators remain unverified.
Further research
Material needed: SPEED is not duplicated across all symptoms and signs; scales, time points, prespecified plans, all symptom tables and denominators remain unverified. This records needed materials; no new research was executed.
Remaining uncertainty
Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.
Conditions for verification
Original material on The main symptom scale, version, time point, baseline and between-group results must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Why this condition is needed
Material on The main symptom scale, version, time point, baseline and between-group results is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.

Related sources R01 R02

N03 · What was the SPEED change in the honey-drop group?

Current findings
The supporting trial reported a within-group SPEED change of 2.53 points, P=.006, in the honey group. This is a before-and-after record in that group.
Verification status
Partly verified
Materials actually read
Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
Reason for missing information
It is not converted into added benefit over existing care; baseline and final values, models, variance, denominators and direct between-group results remain unverified. No new difference or CI is calculated.
Required materials and conditions
The honey group's 3-week SPEED change, original analysis and denominator
Materials to obtain first
It is not converted into added benefit over existing care; baseline and final values, models, variance, denominators and direct between-group results remain unverified. No new difference or CI is calculated.
Further research
Material needed: It is not converted into added benefit over existing care; baseline and final values, models, variance, denominators and direct between-group results remain unverified. No new difference or CI is calculated. This records needed materials; no new research was executed.
Remaining uncertainty
Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.
Conditions for verification
Original material on The honey group's 3-week SPEED change, original analysis and denominator must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Why this condition is needed
Material on The honey group's 3-week SPEED change, original analysis and denominator is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.

Related sources R01 R02

N04 · How is the regular-lubricant group's change distinguished?

Current findings
The original control within-group change was 1.087 points, P=.183. Nonsignificance in control is not a test of honey-group superiority.
Verification status
Partly verified
Materials actually read
Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
Reason for missing information
Control ingredients, within-group tables, denominators, dispersion and between-group contrasts remain unverified. 1.087 is not subtracted from 2.53 to create a new added effect.
Required materials and conditions
The regular-lubricant group's 3-week SPEED change and comparison conditions
Materials to obtain first
Control ingredients, within-group tables, denominators, dispersion and between-group contrasts remain unverified. 1.087 is not subtracted from 2.53 to create a new added effect.
Further research
Material needed: Control ingredients, within-group tables, denominators, dispersion and between-group contrasts remain unverified. 1.087 is not subtracted from 2.53 to create a new added effect. This records needed materials; no new research was executed.
Remaining uncertainty
Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.
Conditions for verification
Original material on The regular-lubricant group's 3-week SPEED change and comparison conditions must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Why this condition is needed
Material on The regular-lubricant group's 3-week SPEED change and comparison conditions is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.

Related sources R01 R02

N05 · Are P=.006 and P=.183 a between-group superiority test?

Current findings
The original account explicitly states that the different within-group P values are not a superiority test.
Verification status
Partly verified
Materials actually read
Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
Reason for missing information
A difference in P values is not treated as a significant difference in effects; direct between-group estimates, CIs, denominators, models, multiplicity and prespecified plans remain unverified.
Required materials and conditions
Direct comparison of the changes, between-group P values and CIs
Materials to obtain first
A difference in P values is not treated as a significant difference in effects; direct between-group estimates, CIs, denominators, models, multiplicity and prespecified plans remain unverified.
Further research
Material needed: A difference in P values is not treated as a significant difference in effects; direct between-group estimates, CIs, denominators, models, multiplicity and prespecified plans remain unverified. This records needed materials; no new research was executed.
Remaining uncertainty
Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.
Conditions for verification
Original material on Direct comparison of the changes, between-group P values and CIs must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Why this condition is needed
Material on Direct comparison of the changes, between-group P values and CIs is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.

Related sources R01 R02

N06 · Are the direct between-group symptom effect and 95% CI verified?

Current findings
The stored summary records that the supporting trial's abstract did not present a direct between-group symptom effect.
Verification status
Unverified
Materials actually read
Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
Reason for missing information
That record about the original abstract is distinguished from external materials being unread in this work. Exact between-group results, CIs, P values, denominators, adjustment and variance remain unverified, without conversion into no effect or established efficacy.
Required materials and conditions
The added symptom effect and its original uncertainty
Materials to obtain first
That record about the original abstract is distinguished from external materials being unread in this work. Exact between-group results, CIs, P values, denominators, adjustment and variance remain unverified, without conversion into no effect or established efficacy.
Further research
Material needed: That record about the original abstract is distinguished from external materials being unread in this work. Exact between-group results, CIs, P values, denominators, adjustment and variance remain unverified, without conversion into no effect or established efficacy. This records needed materials; no new research was executed.
Remaining uncertainty
Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.
Conditions for verification
Original material on The added symptom effect and its original uncertainty must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Why this condition is needed
Material on The added symptom effect and its original uncertainty is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.

Related sources R01 R02

N07 · Can overall improvement in 114 participants and 3 groups be assigned to the product?

Current findings
All groups in the principal trial improved and used common warm compresses, lid massage and preservative-free lubricant.
Verification status
Partly verified
Materials actually read
Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
Reason for missing information
Overall improvement is not assigned to honey as an ingredient; group-specific symptoms, baselines, time points, denominators, common-care adherence and direct between-group contrasts remain unverified.
Required materials and conditions
Added symptom benefit over common care and group-specific results
Materials to obtain first
Overall improvement is not assigned to honey as an ingredient; group-specific symptoms, baselines, time points, denominators, common-care adherence and direct between-group contrasts remain unverified.
Further research
Material needed: Overall improvement is not assigned to honey as an ingredient; group-specific symptoms, baselines, time points, denominators, common-care adherence and direct between-group contrasts remain unverified. This records needed materials; no new research was executed.
Remaining uncertainty
Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.
Conditions for verification
Original material on Added symptom benefit over common care and group-specific results must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Why this condition is needed
Material on Added symptom benefit over common care and group-specific results is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.

Related sources R01 R02

N08 · Are 16% drops and 98% gel the same formulation?

Current findings
The original record distinguishes 16% drops and 98% gel as different formulations.
Verification status
Partly verified
Materials actually read
Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
Reason for missing information
An effect from one formulation is not copied to or pooled with another. Formulation-specific products, administered amounts, frequency, symptom scales, denominators, time points and between-group effects remain unverified.
Required materials and conditions
Formulation-specific symptom effects, administered amounts, frequency and control
Materials to obtain first
An effect from one formulation is not copied to or pooled with another. Formulation-specific products, administered amounts, frequency, symptom scales, denominators, time points and between-group effects remain unverified.
Further research
Material needed: An effect from one formulation is not copied to or pooled with another. Formulation-specific products, administered amounts, frequency, symptom scales, denominators, time points and between-group effects remain unverified. This records needed materials; no new research was executed.
Remaining uncertainty
Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.
Conditions for verification
Original material on Formulation-specific symptom effects, administered amounts, frequency and control must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Why this condition is needed
Material on Formulation-specific symptom effects, administered amounts, frequency and control is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.

Related sources R01 R02

N09 · Are selected P values for clinical signs symptom effects?

Current findings
In the principal trial, staining with drops P=.035 and gel meibum quality P=.005 and gland expressibility P=.042 were signals in selected signs.
Verification status
Partly verified
Materials actually read
Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
Reason for missing information
These values are not converted into SPEED or patient symptom-effect estimates. Original sign and symptom tables, hierarchy, denominators, formulation and time-point matching remain unverified.
Required materials and conditions
The direct relevance of staining and meibomian measures to symptom outcomes
Materials to obtain first
These values are not converted into SPEED or patient symptom-effect estimates. Original sign and symptom tables, hierarchy, denominators, formulation and time-point matching remain unverified.
Further research
Material needed: These values are not converted into SPEED or patient symptom-effect estimates. Original sign and symptom tables, hierarchy, denominators, formulation and time-point matching remain unverified. This records needed materials; no new research was executed.
Remaining uncertainty
Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.
Conditions for verification
Original material on The direct relevance of staining and meibomian measures to symptom outcomes must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Why this condition is needed
Material on The direct relevance of staining and meibomian measures to symptom outcomes is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.

Related sources R01 R02

N10 · Does assessor masking also mean participant masking?

Current findings
The supporting trial's original design was an assessor-masked randomized trial.
Verification status
Partly verified
Materials actually read
Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
Reason for missing information
Double masking of participants and treatment providers or exclusion of expectancy effects is not newly verified. Allocation, concealment, masking roles, symptom responses, control appearance, stinging and assessment methods remain unverified.
Required materials and conditions
The roles of assessor masking and symptom reporting and measurement
Materials to obtain first
Double masking of participants and treatment providers or exclusion of expectancy effects is not newly verified. Allocation, concealment, masking roles, symptom responses, control appearance, stinging and assessment methods remain unverified.
Further research
Material needed: Double masking of participants and treatment providers or exclusion of expectancy effects is not newly verified. Allocation, concealment, masking roles, symptom responses, control appearance, stinging and assessment methods remain unverified. This records needed materials; no new research was executed.
Remaining uncertainty
Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.
Conditions for verification
Original material on The roles of assessor masking and symptom reporting and measurement must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Why this condition is needed
Material on The roles of assessor masking and symptom reporting and measurement is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.

Related sources R01 R02

N11 · What are the limitations of open treatment and multiple outcomes?

Current findings
The principal trial used an open 3-group randomized design and retained multiple symptoms and signs.
Verification status
Partly verified
Materials actually read
Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
Reason for missing information
Selected findings are not expanded into superiority for all symptoms. Original methods, registration, protocols, analysis plans, all time points and multiplicity plans remain unverified; no new official assessment is created.
Required materials and conditions
The principal trial's open 3-group methods, prespecified symptom outcomes and all results
Materials to obtain first
Selected findings are not expanded into superiority for all symptoms. Original methods, registration, protocols, analysis plans, all time points and multiplicity plans remain unverified; no new official assessment is created.
Further research
Material needed: Selected findings are not expanded into superiority for all symptoms. Original methods, registration, protocols, analysis plans, all time points and multiplicity plans remain unverified; no new official assessment is created. This records needed materials; no new research was executed.
Remaining uncertainty
Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.
Conditions for verification
Original material on The principal trial's open 3-group methods, prespecified symptom outcomes and all results must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Why this condition is needed
Material on The principal trial's open 3-group methods, prespecified symptom outcomes and all results is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.

Related sources R01 R02

N12 · Are 3 weeks and the principal 8 weeks the same duration?

Current findings
The principal direct trial's 8 weeks and the supporting trial's 3-week SPEED measure are distinguished in the original account.
Verification status
Partly verified
Materials actually read
Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
Reason for missing information
One trial's time point is not assigned to another trial or to long-term durability. Report-specific schedules, administration, adherence, endpoint denominators and long-term and post-stopping material remain unverified.
Required materials and conditions
The supporting trial's 3 weeks, the principal trial's 8 weeks, and long-term and post-stopping results
Materials to obtain first
One trial's time point is not assigned to another trial or to long-term durability. Report-specific schedules, administration, adherence, endpoint denominators and long-term and post-stopping material remain unverified.
Further research
Material needed: One trial's time point is not assigned to another trial or to long-term durability. Report-specific schedules, administration, adherence, endpoint denominators and long-term and post-stopping material remain unverified. This records needed materials; no new research was executed.
Remaining uncertainty
Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.
Conditions for verification
Original material on The supporting trial's 3 weeks, the principal trial's 8 weeks, and long-term and post-stopping results must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Why this condition is needed
Material on The supporting trial's 3 weeks, the principal trial's 8 weeks, and long-term and post-stopping results is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.

Related sources R01 R02

N13 · Are symptom importance, responders and lubricant use verified?

Current findings
The original outcome list includes symptoms and lubricant use, but prespecified importance, responders and exact between-group medication use are not detailed.
Verification status
Partly verified
Materials actually read
Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
Reason for missing information
Thresholds, responders, medication use, denominators, CIs and prespecified hierarchy remain unverified. Within-group means are not converted into treatment-success rates or medication replacement.
Required materials and conditions
Direct material on SPEED importance, responders, lubricant and rescue-medication use
Materials to obtain first
Thresholds, responders, medication use, denominators, CIs and prespecified hierarchy remain unverified. Within-group means are not converted into treatment-success rates or medication replacement.
Further research
Material needed: Thresholds, responders, medication use, denominators, CIs and prespecified hierarchy remain unverified. Within-group means are not converted into treatment-success rates or medication replacement. This records needed materials; no new research was executed.
Remaining uncertainty
Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.
Conditions for verification
Original material on Direct material on SPEED importance, responders, lubricant and rescue-medication use must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Why this condition is needed
Material on Direct material on SPEED importance, responders, lubricant and rescue-medication use is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.

Related sources R01 R02

N14 · How are medical-grade sterile products distinguished from food honey?

Current findings
The original record concerns ophthalmic medical-grade products, not evidence for food-grade manuka honey or homemade dilution. Concentration differs from actual instilled amount and frequency.
Verification status
Partly verified
Materials actually read
Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
Reason for missing information
Product, sterility, ingredients, manufacture, dose, frequency and administration records remain unverified in detail. Medical-grade product records are not expanded into effects of food-grade or nonsterile products.
Required materials and conditions
Manufacture, quality and actual administration of medical-grade 16% drops and 98% gel
Materials to obtain first
Product, sterility, ingredients, manufacture, dose, frequency and administration records remain unverified in detail. Medical-grade product records are not expanded into effects of food-grade or nonsterile products.
Further research
Material needed: Product, sterility, ingredients, manufacture, dose, frequency and administration records remain unverified in detail. Medical-grade product records are not expanded into effects of food-grade or nonsterile products. This records needed materials; no new research was executed.
Remaining uncertainty
Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.
Conditions for verification
Original material on Manufacture, quality and actual administration of medical-grade 16% drops and 98% gel must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Why this condition is needed
Material on Manufacture, quality and actual administration of medical-grade 16% drops and 98% gel is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.

Related sources R01 R02

N15 · What was added to common lid care?

Current findings
In 2017, all groups used common warm compresses, lid massage and preservative-free lubricant. The comparison added medical-grade honey products to that care.
Verification status
Partly verified
Materials actually read
Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
Reason for missing information
It is not converted into evidence for stopping care or standalone treatment. Common-care rules, adherence, additional and rescue medications, formulation-specific matching and changes remain unverified.
Required materials and conditions
Warm compresses, massage, preservative-free lubricant and formulation-specific additional care
Materials to obtain first
It is not converted into evidence for stopping care or standalone treatment. Common-care rules, adherence, additional and rescue medications, formulation-specific matching and changes remain unverified.
Further research
Material needed: It is not converted into evidence for stopping care or standalone treatment. Common-care rules, adherence, additional and rescue medications, formulation-specific matching and changes remain unverified. This records needed materials; no new research was executed.
Remaining uncertainty
Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.
Conditions for verification
Original material on Warm compresses, massage, preservative-free lubricant and formulation-specific additional care must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Why this condition is needed
Material on Warm compresses, massage, preservative-free lubricant and formulation-specific additional care is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.

Related sources R01 R02

N16 · Are MGD diagnosis and sample size the same information?

Current findings
The parent question concerns evaporative dry eye from meibomian gland dysfunction. 114 participants is the original sample-size label.
Verification status
Partly verified
Materials actually read
Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
Reason for missing information
Sample size does not replace diagnostic or eligibility criteria. Diagnosis, severity, baseline symptoms and signs, age, comorbidities and group-specific inclusion and exclusion remain unverified.
Required materials and conditions
Diagnosis, severity, baseline status and group-specific eligibility in evaporative dry eye
Materials to obtain first
Sample size does not replace diagnostic or eligibility criteria. Diagnosis, severity, baseline symptoms and signs, age, comorbidities and group-specific inclusion and exclusion remain unverified.
Further research
Material needed: Sample size does not replace diagnostic or eligibility criteria. Diagnosis, severity, baseline symptoms and signs, age, comorbidities and group-specific inclusion and exclusion remain unverified. This records needed materials; no new research was executed.
Remaining uncertainty
Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.
Conditions for verification
Original material on Diagnosis, severity, baseline status and group-specific eligibility in evaporative dry eye must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Why this condition is needed
Material on Diagnosis, severity, baseline status and group-specific eligibility in evaporative dry eye is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.

Related sources R01 R02

N17 · What are the symptom denominators in 114 participants and 3 groups?

Current findings
The principal trial's sample was 114 participants and its design was an open 3-group randomized trial.
Verification status
Partly verified
Materials actually read
Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
Reason for missing information
Group allocation, completion, formulations, care groups, endpoints, time points, bilateral-eye and patient denominators and exclusions remain unverified. Denominators absent from the original are not created.
Required materials and conditions
Group allocation, completion, analysis and endpoint-specific eye and patient denominators
Materials to obtain first
Group allocation, completion, formulations, care groups, endpoints, time points, bilateral-eye and patient denominators and exclusions remain unverified. Denominators absent from the original are not created.
Further research
Material needed: Group allocation, completion, formulations, care groups, endpoints, time points, bilateral-eye and patient denominators and exclusions remain unverified. Denominators absent from the original are not created. This records needed materials; no new research was executed.
Remaining uncertainty
Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.
Conditions for verification
Original material on Group allocation, completion, analysis and endpoint-specific eye and patient denominators must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Why this condition is needed
Material on Group allocation, completion, analysis and endpoint-specific eye and patient denominators is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.

Related sources R01 R02

N18 · What denominators are 59 randomized and 55 completed?

Current findings
The supporting trial originally recorded 59 randomized and 55 completed. These values describe separate stages.
Verification status
Partly verified
Materials actually read
Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
Reason for missing information
Attrition counts or group-specific and endpoint-specific analysis denominators are not calculated or established. Group flow, reasons, time points and eye and patient denominators remain unverified.
Required materials and conditions
Supporting-trial allocation, completion, analysis and group, eye and patient endpoint denominators
Materials to obtain first
Attrition counts or group-specific and endpoint-specific analysis denominators are not calculated or established. Group flow, reasons, time points and eye and patient denominators remain unverified.
Further research
Material needed: Attrition counts or group-specific and endpoint-specific analysis denominators are not calculated or established. Group flow, reasons, time points and eye and patient denominators remain unverified. This records needed materials; no new research was executed.
Remaining uncertainty
Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.
Conditions for verification
Original material on Supporting-trial allocation, completion, analysis and group, eye and patient endpoint denominators must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Why this condition is needed
Material on Supporting-trial allocation, completion, analysis and group, eye and patient endpoint denominators is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.

Related sources R01 R02

N19 · What is the impact of missingness, attrition and measurement exclusions?

Current findings
Overall sample and completion records exist, but endpoint-specific missingness, attrition reasons and analysis conditions are not detailed.
Verification status
Unverified
Materials actually read
Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
Reason for missing information
Unread external material is not converted into absence of missingness. Missingness, stopping, exclusions, ITT and completer analyses, missing-data handling, sensitivity and group and eye matching remain unverified.
Required materials and conditions
Group flow, missing symptom outcomes, analysis populations and sensitivity analyses
Materials to obtain first
Unread external material is not converted into absence of missingness. Missingness, stopping, exclusions, ITT and completer analyses, missing-data handling, sensitivity and group and eye matching remain unverified.
Further research
Material needed: Unread external material is not converted into absence of missingness. Missingness, stopping, exclusions, ITT and completer analyses, missing-data handling, sensitivity and group and eye matching remain unverified. This records needed materials; no new research was executed.
Remaining uncertainty
Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.
Conditions for verification
Original material on Group flow, missing symptom outcomes, analysis populations and sensitivity analyses must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Why this condition is needed
Material on Group flow, missing symptom outcomes, analysis populations and sensitivity analyses is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.

Related sources R01 R02

N20 · What were the baseline adjustment, change and testing conditions?

Current findings
Original P values and selected changes are retained, but detailed adjustment, variance, time points, denominators and effects of interest remain unread in external originals.
Verification status
Unverified
Materials actually read
Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
Reason for missing information
Original analysis plans, statistical tables, baseline and changes, within-eye and within-person correlation, models and CIs remain unverified. New effects or CIs are not back-calculated.
Required materials and conditions
The effect of interest, baseline adjustment, change and final values, and variance
Materials to obtain first
Original analysis plans, statistical tables, baseline and changes, within-eye and within-person correlation, models and CIs remain unverified. New effects or CIs are not back-calculated.
Further research
Material needed: Original analysis plans, statistical tables, baseline and changes, within-eye and within-person correlation, models and CIs remain unverified. New effects or CIs are not back-calculated. This records needed materials; no new research was executed.
Remaining uncertainty
Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.
Conditions for verification
Original material on The effect of interest, baseline adjustment, change and final values, and variance must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Why this condition is needed
Material on The effect of interest, baseline adjustment, change and final values, and variance is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.

Related sources R01 R02

N21 · Does a registration number also verify prespecified plans?

Current findings
Registration was unverified for the principal trial, while NCT04457648 was recorded for the supporting trial.
Verification status
Partly verified
Materials actually read
Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
Reason for missing information
The number's existence is not promoted into registration reading in this work, prespecification, hierarchy at all time points or plan adherence. Official registration history, protocols and analysis plans were unread in this work.
Required materials and conditions
Registration, history, primary outcomes, changes and original plans for both trials
Materials to obtain first
The number's existence is not promoted into registration reading in this work, prespecification, hierarchy at all time points or plan adherence. Official registration history, protocols and analysis plans were unread in this work.
Further research
Material needed: The number's existence is not promoted into registration reading in this work, prespecification, hierarchy at all time points or plan adherence. Official registration history, protocols and analysis plans were unread in this work. This records needed materials; no new research was executed.
Remaining uncertainty
Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.
Conditions for verification
Original material on Registration, history, primary outcomes, changes and original plans for both trials must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Why this condition is needed
Material on Registration, history, primary outcomes, changes and original plans for both trials is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.

Related sources R01 R02

N22 · Do parent and subquestions share the same reports?

Current findings
The parent and subquestions share the same Albietz 2017 and Wong 2021 reports.
Verification status
Partly verified
Materials actually read
Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
Reason for missing information
Sheet counts are not counted as new studies or independent replications. Report, trial, registration, sample, institution, timing and additional-report matching and unique trial and participant totals remain unverified.
Required materials and conditions
Report, trial and participant links between the symptom question and other questions
Materials to obtain first
Sheet counts are not counted as new studies or independent replications. Report, trial, registration, sample, institution, timing and additional-report matching and unique trial and participant totals remain unverified.
Further research
Material needed: Sheet counts are not counted as new studies or independent replications. Report, trial, registration, sample, institution, timing and additional-report matching and unique trial and participant totals remain unverified. This records needed materials; no new research was executed.
Remaining uncertainty
Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.
Conditions for verification
Original material on Report, trial and participant links between the symptom question and other questions must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Why this condition is needed
Material on Report, trial and participant links between the symptom question and other questions is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.

Related sources R01 R02

N23 · Is independent replication across teams, products and formulations verified?

Current findings
The bibliographies of both reports retain an Albietz author and the specific Optimel product context.
Verification status
Partly verified
Materials actually read
Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
Reason for missing information
Different reports or assessor masking alone do not newly establish independent teams or replication under the same conditions. Team, institution, product, funding, participant, effect and denominator matching remain unverified.
Required materials and conditions
Unique trials and independent teams for the same symptoms, formulation, population, comparison and time point
Materials to obtain first
Different reports or assessor masking alone do not newly establish independent teams or replication under the same conditions. Team, institution, product, funding, participant, effect and denominator matching remain unverified.
Further research
Material needed: Different reports or assessor masking alone do not newly establish independent teams or replication under the same conditions. Team, institution, product, funding, participant, effect and denominator matching remain unverified. This records needed materials; no new research was executed.
Remaining uncertainty
Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.
Conditions for verification
Original material on Unique trials and independent teams for the same symptoms, formulation, population, comparison and time point must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Why this condition is needed
Material on Unique trials and independent teams for the same symptoms, formulation, population, comparison and time point is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.

Related sources R01 R02

N24 · How much is known about product provision and company involvement?

Current findings
The principal trial records Optimel product provision and related involvement; the supporting trial records a specific Optimel product, provision and author conflict disclosure.
Verification status
Partly verified
Materials actually read
Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
Reason for missing information
Unrecorded funding, employee relationships, analysis and publication roles remain unverified. Product provision is not treated as verification of every involvement route or as absence of independence.
Required materials and conditions
Trial-specific funding, product support, employee authors and conflicts
Materials to obtain first
Unrecorded funding, employee relationships, analysis and publication roles remain unverified. Product provision is not treated as verification of every involvement route or as absence of independence.
Further research
Material needed: Unrecorded funding, employee relationships, analysis and publication roles remain unverified. Product provision is not treated as verification of every involvement route or as absence of independence. This records needed materials; no new research was executed.
Remaining uncertainty
Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.
Conditions for verification
Original material on Trial-specific funding, product support, employee authors and conflicts must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Why this condition is needed
Material on Trial-specific funding, product support, employee authors and conflicts is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.

Related sources R01 R02

N25 · What is the scope of reported stinging and redness?

Current findings
The original record reports temporary stinging and redness and cautions that initial symptoms are possible even with medical-grade formulations.
Verification status
Partly verified
Materials actually read
Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
Reason for missing information
Event counts, incidence or new causality are not created. Collection methods, group and formulation-specific events, severity, timing, stopping, missingness and controls remain unverified.
Required materials and conditions
Medical-grade product adverse reactions, collection methods, stopping and controls
Materials to obtain first
Event counts, incidence or new causality are not created. Collection methods, group and formulation-specific events, severity, timing, stopping, missingness and controls remain unverified.
Further research
Material needed: Event counts, incidence or new causality are not created. Collection methods, group and formulation-specific events, severity, timing, stopping, missingness and controls remain unverified. This records needed materials; no new research was executed.
Remaining uncertainty
Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.
Conditions for verification
Original material on Medical-grade product adverse reactions, collection methods, stopping and controls must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Why this condition is needed
Material on Medical-grade product adverse reactions, collection methods, stopping and controls is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.

Related sources R01 R02

N26 · What are the eye and patient harm denominators and exposures?

Current findings
114 participants, 59 randomized and 55 completed do not verify safety denominators. Concentrations, formulations, 3 and 8 weeks and common care are not combined as the same harm exposure.
Verification status
Unverified
Materials actually read
Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
Reason for missing information
Safety denominators, actual instillation, group, eye and formulation-specific events, stopping, exposure and controls remain unverified. Incidence is not calculated.
Required materials and conditions
Safety populations, eyes, patients, formulations, durations and actual instillation exposure
Materials to obtain first
Safety denominators, actual instillation, group, eye and formulation-specific events, stopping, exposure and controls remain unverified. Incidence is not calculated.
Further research
Material needed: Safety denominators, actual instillation, group, eye and formulation-specific events, stopping, exposure and controls remain unverified. Incidence is not calculated. This records needed materials; no new research was executed.
Remaining uncertainty
Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.
Conditions for verification
Original material on Safety populations, eyes, patients, formulations, durations and actual instillation exposure must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Why this condition is needed
Material on Safety populations, eyes, patients, formulations, durations and actual instillation exposure is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.

Related sources R01 R02

N27 · Are food or nonsterile risks distinguished from medical-grade product reactions?

Current findings
The original caution distinguishes infection and corneal-injury risks with food-grade, nonsterile and homemade dilutions from initial stinging and redness with medical-grade products.
Verification status
Partly verified
Materials actually read
Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
Reason for missing information
The food-honey self-instillation question is distinguished and no new case is created. Products, baseline eye conditions, concurrent use, event timing, alternative causes, controls and course remain unverified; no new harm causality is judged.
Required materials and conditions
Manufacture, sterility, baseline eye conditions, other causes and clinical course
Materials to obtain first
The food-honey self-instillation question is distinguished and no new case is created. Products, baseline eye conditions, concurrent use, event timing, alternative causes, controls and course remain unverified; no new harm causality is judged.
Further research
Material needed: The food-honey self-instillation question is distinguished and no new case is created. Products, baseline eye conditions, concurrent use, event timing, alternative causes, controls and course remain unverified; no new harm causality is judged. This records needed materials; no new research was executed.
Remaining uncertainty
Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.
Conditions for verification
Original material on Manufacture, sterility, baseline eye conditions, other causes and clinical course must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Why this condition is needed
Material on Manufacture, sterility, baseline eye conditions, other causes and clinical course is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.

Related sources R01 R02

N28 · Are long-term, rare and vulnerable-population harms verified?

Current findings
Small short-term trials of specific products and descriptions of temporary reactions do not verify long-term, rare or vulnerable-population safety.
Verification status
Unverified
Materials actually read
Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
Reason for missing information
Long follow-up, independent harm reports, vulnerable populations, exposure, denominators, concurrent use and course remain unverified. No external search or new harm judgment was performed in this work.
Required materials and conditions
Long exposure, independent harm reports, vulnerable populations and follow-up
Materials to obtain first
Long follow-up, independent harm reports, vulnerable populations, exposure, denominators, concurrent use and course remain unverified. No external search or new harm judgment was performed in this work.
Further research
Material needed: Long follow-up, independent harm reports, vulnerable populations, exposure, denominators, concurrent use and course remain unverified. No external search or new harm judgment was performed in this work. This records needed materials; no new research was executed.
Remaining uncertainty
Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.
Conditions for verification
Original material on Long exposure, independent harm reports, vulnerable populations and follow-up must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Why this condition is needed
Material on Long exposure, independent harm reports, vulnerable populations and follow-up is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.

Related sources R01 R02

N29 · How does stored-summary reading differ from reading external originals?

Current findings
The complete parent Korean and English summary, reports and citations were read. PubMed URLs and registration numbers are existing records; external abstracts, full texts, registration, protocols and analysis plans were unread in this work.
Verification status
Partly verified
Materials actually read
Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
Reason for missing information
URLs, numbers and historical verification wording do not establish current reading, successful access or fulfilled conditions. External detailed-material availability, acquisition and actual reading remain separately unverified.
Required materials and conditions
The complete stored summary and the reading scope for external abstracts, full texts, registration and plans
Materials to obtain first
URLs, numbers and historical verification wording do not establish current reading, successful access or fulfilled conditions. External detailed-material availability, acquisition and actual reading remain separately unverified.
Further research
Material needed: URLs, numbers and historical verification wording do not establish current reading, successful access or fulfilled conditions. External detailed-material availability, acquisition and actual reading remain separately unverified. This records needed materials; no new research was executed.
Remaining uncertainty
Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.
Conditions for verification
Original material on The complete stored summary and the reading scope for external abstracts, full texts, registration and plans must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Why this condition is needed
Material on The complete stored summary and the reading scope for external abstracts, full texts, registration and plans is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.

Related sources R01 R02

N30 · What do selected C, parent C46, dates and empty values record?

Current findings
The selected grade is C, with no individual score, status or axes fields. Parent C46, caution, axes, Korean and English records, 2026-09-07 and empty correction and deliberation records are preserved separately.
Verification status
Partly verified
Materials actually read
Complete stored parent Korean and English summary, selected question and bibliography read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified
This state links partial information and gaps in the preserved selected and parent accounts. External verification and clinical content review remain incomplete; it does not certify fulfilled conditions, efficacy, safety, prespecification or independence.
Reason for missing information
The parent's 46 points are not assigned as a subclaim score, and the historical evidence date is not changed into a new search, external reading or completed-review date. New material, condition revisions and verdict changes are separate events.
Required materials and conditions
The selected grade, absent individual score, parent axes, evidence date and corrections
Materials to obtain first
The parent's 46 points are not assigned as a subclaim score, and the historical evidence date is not changed into a new search, external reading or completed-review date. New material, condition revisions and verdict changes are separate events.
Further research
Material needed: The parent's 46 points are not assigned as a subclaim score, and the historical evidence date is not changed into a new search, external reading or completed-review date. New material, condition revisions and verdict changes are separate events. This records needed materials; no new research was executed.
Remaining uncertainty
Direct between-group symptom effects, CIs, importance, group and eye denominators, baseline adjustment, missingness, prespecified plans, actual exposure, involvement and independence, long-term effects and harms remain unverified. Original numbers and historical verification wording are not promoted into new calculations, current external reading or completed clinical review.
Conditions for verification
Original material on The selected grade, absent individual score, parent axes, evidence date and corrections must link to the same question, control, endpoint, time point and denominators, distinguishing within- and between-group results, parent context and unread external materials.
Why this condition is needed
Material on The selected grade, absent individual score, parent axes, evidence date and corrections is needed to connect the medical-grade product, formulation, existing care, population, comparison, symptoms and signs, time point, denominators, precision and harms.
Application exceptions
Selected C and absent individual score, status and axes are retained, distinguishing parent C46, selected-signs C and food-honey self-instillation F. Within-group P values and signs are not converted into direct between-group symptom effects, and formulations, eyes and patients, and safety denominators are not combined. No new effects, CIs, differences, attrition counts, incidence, unique totals, grades or individual-care guidance are created.
Referenced methods
Preserved principles distinguishing questions, direct comparisons, reports and trials, endpoints, denominators, precision and harms informed production.

Related sources R01 R02