Lutein, zeaxanthin, curcumin, and vitamin D3 combination capsule × Improved day-56 tear volume and OSDI

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Partly verified	Full text not readStored summary read	N01 · Evidence conditionSelected day-56 coprimary results and original valuesRequired	Retain subclaim C and its note for improved day-56 tear volume and OSDI. Parent C50 and axes are parent-assessment context. S01 S02	Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Subclaim score/status/axes are absent and are not filled from parent values. Do not split/promote coprimary results into new subunits or grades. Content review remains incomplete.	Original question, grade/note, parent context and absent fields	Update research linking the original question with additional material; no new search, calculation or trial was performed here.
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionPopulation with mild-to-moderate dry eyeRequired	Retain the original 2021 Indian single-center population of 60 adults with mild-to-moderate dry eye, allocated 30/30. S01 S02	Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Detailed eligibility, baseline symptoms/tears, age/comorbidity, group characteristics and correspondence with the 2024 population are unverified. Content review remains incomplete.	Recruitment, disease/baseline conditions and group characteristics	Further research on population-specific applicability and heterogeneity; no new search, calculation or trial was performed here.
3	Partly verified	Full text not readStored summary read	N03 · Evidence conditionFixed four-ingredient combination capsuleRequired	Retain lutein 20 mg, zeaxanthin 4 mg, curcuminoids 200 mg and vitamin D3 600 IU. Do not decompose results into individual-ingredient or other-blend effects. S01 S02	Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Complete formulation/batch, additives/exposure, ingredient identity, actual product correspondence and adherence are unverified. No new conversion or use instructions. Content review remains incomplete.	Ingredient combination, formulation/dose and product identity	Research distinguishing combination formulation from attribution of results; no new search, calculation or trial was performed here.
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionVisually matched soybean-oil placeboRequired	The 2021 placebo was a visually matched soybean-oil capsule. The 2024 trial was also placebo-controlled, with detailed matching separately unverified. S01 S02	Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Other ingredients/sensory features, group exposure, adherence/crossover and actual comparator conditions are unverified. Content review remains incomplete.	Comparator formulation, sensory matching and concurrent exposure	Research distinguishing comparator and measurement-condition differences; no new search, calculation or trial was performed here.
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionDay-56/eight-week exposure and follow-upRequired	Retain eight-week/day-56 pivotal-trial and day-56 follow-up-trial results. Do not fill later durability or identical-duration exposure for all participants. S01 S02	Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Individual starts/stopping, adherence, visit windows, repeated/intermediate results and later follow-up are unverified. Content review remains incomplete.	Distinguish exposure period, visits/measurement and actual completion	Follow-up research on periods, timing and durability; no new search, calculation or trial was performed here.
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionRandomization and blinding proceduresRequired	Retain double-blind placebo-controlled randomized designs in both original evidence records. The 2021 30/30 and 2024 155 participants are separate trial denominators. S01 S02	Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Original sequence/concealment, role-specific blinding/maintenance and actual measurement/analysis procedures are unread. Design labels alone do not certify absence of bias. Content review remains incomplete.	Allocation/concealment and participant, measurement, assessment and analysis roles	Research on relationships between procedures and observed results; no new search, calculation or trial was performed here.
7	Partly verified	Full text not readStored summary read	N07 · Evidence condition2021: 60 randomized and 59 complete casesRequired	Retain 60 randomized, 30/30, and 59 in complete-case analysis. Do not calculate new missing/group-excluded counts or declare full ITT. S01	Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Group completion/omissions, reasons, endpoint-specific observations, models and missingness sensitivity are unverified. Content review remains incomplete.	Randomized/observed/analyzed denominators, omissions and missingness	Further research on complete-case selection and omission assumptions; no new search, calculation or trial was performed here.
8	Partly verified	Full text not readStored summary read	N08 · Evidence conditionOriginal baseline and final OSDI valuesRequired	Retain 2021 product 30.10±4.88→17.09±4.85 and placebo 32.54±5.06→31.00±7.18 as baseline/day-56 values. Do not calculate changes, group differences or response rates. S01	Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Scale/units, meaning of ±, observed/analyzed group denominators, models/adjustment and individual values are unverified. Content review remains incomplete.	Group OSDI timing, units, estimates and variability	Research on baseline/final values, changes and between-group estimates; no new search, calculation or trial was performed here.
9	Partly verified	Full text not readStored summary read	N09 · Evidence conditionOSDI between-group P value and precisionRequired	Retain 2021 between-group OSDI P=.0001. Do not derive new effects/CIs from group baseline/final numbers. S01	Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Exact group estimates/95% CIs, models/adjustment, prespecified important differences and test details are unverified or originally unreported. Content review remains incomplete.	Selected between-group estimate/CI, test and model	Research distinguishing precision from clinical meaning; no new search, calculation or trial was performed here.
10	Partly verified	Full text not readStored summary read	N10 · Evidence conditionSchirmer tear volume and measurementRequired	Schirmer is a different measure from OSDI symptoms. Retain 2021 between-group P<.0001. S01	Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Test conditions/methods, assessed eyes/repetitions, group mm values, observation denominators/models and precision are unverified. Do not transfer symptom values into tear volume. Content review remains incomplete.	Tear-volume definition/units, test conditions and assessed eyes	Research distinguishing objective tests from symptom outcomes; no new search, calculation or trial was performed here.
11	Partly verified	Full text not readStored summary read	N11 · Evidence conditionCoprimary outcomes, multiplicity and hierarchyRequired	Retain the original note that day-56 Schirmer and OSDI coprimary outcomes were both positive. Do not change original coprimary_split=false or create sibling units. S01 S02	Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Original registration/protocol/SAP, success criteria, all time points/outcomes, multiplicity, hierarchy and changes are unread. Content review remains incomplete.	Success rules for two prespecified endpoints and multiple comparisons/time points	Research distinguishing prospective hierarchy from selected outcomes; no new search, calculation or trial was performed here.
12	Partly verified	Full text not readStored summary read	N12 · Evidence conditionCIs and prespecified importance thresholdsRequired	Retain historical wording that pivotal-trial tables lacked between-group 95% CIs and prespecified minimum clinically important Schirmer-mm/OSDI differences. S01 S02	Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Exact estimates/original output, prespecified thresholds and follow-up-trial CIs/criteria are unverified. P values do not certify new CIs or clinical success. Content review remains incomplete.	Separate evidence for group CIs and clinical importance	Research on statistical results, important differences and uncertainty; no new search, calculation or trial was performed here.
13	Partly verified	Full text not readStored summary read	N13 · Evidence condition2024: four centers, 155 randomized and 116 analyzedRequired	Retain the four-center US follow-up trial with 155 randomized and 116 analyzed. Do not sum these with pivotal-trial 60/59 or infer group denominators. S02	Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Group recruitment/allocation/observation, analysis criteria, attrition/missingness and endpoint denominators/models are unverified. Content review remains incomplete.	Follow-up-trial population, denominators, analysis and exclusions	Research on analysis populations, omissions and follow-up results; no new search, calculation or trial was performed here.
14	Partly verified	Full text not readStored summary read	N14 · Evidence condition2024 Schirmer/OSDIRequired	Retain original wording that follow-up day-56 Schirmer and OSDI both improved versus placebo, P<.001. Do not transfer 2021 group OSDI values/denominators to this trial. S02	Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Exact values/effects/CIs, models, assessed eyes/units, baseline/final/change and hierarchy are unverified. Content review remains incomplete.	Original group results for each measure and correspondence to its trial	Research distinguishing formulation-specific measures and populations; no new search, calculation or trial was performed here.
15	Partly verified	Full text not readStored summary read	N15 · Evidence conditionArtificial-tear use: P=.562, a separate outcomeRequired	Retain original 2024 follow-up artificial-tear-use result described as null, between-group P=.562. Do not transfer Schirmer/OSDI positivity into reduced-use benefit. S02	Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Use measure, counts/people, baseline/follow-up, group values/denominators, CIs/models and hierarchy are unverified. No new zero-effect or equivalence claim. Content review remains incomplete.	Use-outcome definition/timing, denominators and estimates	Research distinguishing other outcomes from uncertainty; no new search, calculation or trial was performed here.
16	Partly verified	Full text not readStored summary read	N16 · Evidence conditionCTRI and NCT registration recordsRequired	Retain 2021 CTRI/2021/01/030493 and 2024 NCT05481450. Do not promote existence, prospective timing or correspondence into original-material reading performed here. S01 S02	Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Registration history, protocol/SAP, recruitment/analysis timing, multiplicity and changes are unread. Content review remains incomplete.	Trial registration, original plans/changes and report correspondence	Research connecting prospective plans to reports; no new search, calculation or trial was performed here.
17	Unverified	Full text not readStored summary read	N17 · Evidence conditionConcurrent eye care and adherenceRequired	Retain original scope of the particular blend versus placebo. Keep follow-up artificial-tear results as a separate endpoint/concurrent-exposure context. S01 S02	Information currently needed is unverified in the preserved summary. Other eye treatments/products, testing/environment, actual adherence/crossover/changes and artificial-tear-use records are unverified. No new management/treatment/consumption instructions. Content review remains incomplete.	Artificial tears/treatment, lifestyle/products and actual exposure	Research on concurrent exposure and attribution of blend results; no new search, calculation or trial was performed here.
18	Partly verified	Full text not readStored summary read	N18 · Evidence condition2021 support, product supply and developmentRequired	Retain original OmniActive study support, manufacturing/supply of product/matched placebo and participation in formulation development. S01	Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Contracts/amounts, supply/cost details, analysis/writing/publication costs and roles/disclosures are unread. Supply facts do not fill support details. Content review remains incomplete.	Distinguish research funding, manufacturing/supply, development and other support	Research on individual support/roles and report relationships; no new search, calculation or trial was performed here.
19	Partly verified	Full text not readStored summary read	N19 · Evidence condition2021: four employee authorsRequired	Retain original Korean/English wording that Priyanka Radkar, Abhijeet Morde, Deshanie Rai and Muralidhara Padigaru were OmniActive-affiliated/employed. S01	Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Author contributions, employment timing/equity, other COI and analysis/writing roles are unread. Current affiliation/independence is not certified. Content review remains incomplete.	Author-specific employment/affiliation, contributions and COI	Research on author relationships and results-reporting roles; no new search, calculation or trial was performed here.
20	Partly verified	Full text not readStored summary read	N20 · Evidence condition2024 trial funding and publication/writing supportRequired	Retain wording that OmniActive funded the trial and Bausch + Lomb provided publication costs and medical-writing/editorial support. S02	Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Contracts, supply/analysis/data, writing contents/publication rights and other support/disclosures are unread. Do not merge 2021 roles or certify new independence. Content review remains incomplete.	Institution-specific trial/publication, writing and editorial roles	Research on individual support and report relationships; no new search, calculation or trial was performed here.
21	Partly verified	Full text not readStored summary read	N21 · Evidence condition2024 employees and advisory-board membersRequired	Retain original AM/DR/MP as OmniActive employees, RR/KB as Bausch + Lomb employees and NG/JG/JP/LP as Bausch + Lomb advisory-board members. Do not expand initials into new names. S02	Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Relationship timing, employment/contracts, contributions/equity, original COI and data/writing roles are unread. Content review remains incomplete.	Author/institution employment, advisory roles, contributions and COI	Research on individual author/institution relationships and reports; no new search, calculation or trial was performed here.
22	Partly verified	Full text not readStored summary read	N22 · Evidence conditionSame company lineage and independenceRequired	Retain original R1/I0 context that both formulation reports share company development/funding lineage rather than replication by independent investigators/funders. S01 S02	Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Actual trial/population/bibliographic correspondence, unique people/overlap and external independence comparison are unverified. Same-direction or multicenter findings do not certify new independence. Content review remains incomplete.	Distinguish two trials/reports, company development/funding and replication	Research distinguishing shared material/company lineage from separate replication; no new search, calculation or trial was performed here.
23	Partly verified	Full text not readStored summary read	N23 · Evidence conditionPeople/eyes, measures and timing totalsRequired	Distinguish 2021 60/59, 2024 155/116, groups/centers, Schirmer/OSDI, timing and sibling sheets. Do not turn original people/analysis counts or eyes/measures into new independent-trial/participant totals. S01 S02	Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Assessed eyes, repeated measurements/observations, person/measure correspondence and unique-person/trial totals were not externally compared. Content review remains incomplete.	Report-trial-person/eye-endpoint duplication and relationships	Research on measurement/reporting units and actual population relationships; no new search, calculation or trial was performed here.
24	Partly verified	Full text not readStored summary read	N24 · Harm-information gaps supplementing the efficacy tableHarm collection and nonreporting scopeSupplementary	Retain original wording that hematology/chemistry, vital signs/physical examinations and adverse events were assessed, with safety problems/serious events unreported. S01 S02	Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Trial/report-specific safety populations, periods, events/denominators, stopping/relatedness, omissions and long-term/vulnerable populations are unverified. Nonreporting is not all harms zero or safety certification. Content review remains incomplete.	Safety populations, collection/examinations and group events/denominators	Research on harm-reporting scope and later follow-up material; no new search, calculation or trial was performed here.
25	Partly verified	Full text not readStored summary read	N25 · Evidence conditionDurability, individual ingredients and other formulationsRequired	These are day-56 tear/symptom results for a fixed four-ingredient blend. Do not decompose/generalize to individual lutein/zeaxanthin/curcumin/vitamin D, other blends or long-term effects. S01 S02	Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Individual ingredients/composition, other doses/populations, post-trial/long-term function/disease outcomes and harms are unverified. No product-selection/consumption/treatment instructions. Content review remains incomplete.	Application outside the selected blend, population and period	Research distinguishing combined attribution from other conditions; no new search, calculation or trial was performed here.
26	Partly verified	Full text not readStored summary read	N26 · Evidence conditionOriginal axes, Korean/English text, dates and correctionsRequired	Complete original preservation retains subclaim C/note, parent C50/Good, B/S/R1/I0/E+/B2, precision null, three false flags, empty overrides, Korean/English, 2026-08-26 and empty corrections/deliberation. S01 S02	Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Historical cross-checks, original nonreporting and coprimary-success/independence wording are not current review, original-material reading or new condition fulfillment. Do not fill absent subclaim score/status/axes or parent classification keys. Content review remains incomplete.	Distinguish subclaim/parent values, dates/corrections and history	Research updating original-material changes and production versions; no new search, calculation or trial was performed here.
27	Partly verified	Full text not readStored summary read	N27 · Evidence conditionSummary read; external material unreadRequired	The preserved JSON summary was read for production and 2021/2024 bibliography/URLs connected. External papers, registration, protocol/SAP and original funding/COI disclosures remain unread and were not accessed. S01 S02	Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. URLs/registration or historical wording do not upgrade external acquisition/reading or content-review states; no external click/link checks were performed. Content review remains incomplete.	Material-specific actual reading, bibliography/URLs and additional-material gaps	Scope-specific update research based on material actually acquired; no new search, calculation or trial was performed here.

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27 itemsWhat the statuses mean

Assessment scope

Stored-material review date: Not recorded
Original evidence cut-off: 2026-08-26
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: Preserve separately the 2021 single-center Indian trial in 60 adults with mild/moderate dry eye (30/30), with 59 complete-case participants, and the 2024 four-center US trial with 155 randomized and 116 analyzed. Detailed eligibility/baseline, group-specific observed/analyzed populations, assessed eyes, repeated measures, exclusions/missingness and correspondence between trials are unverified; no new combined or missing counts are calculated.
Ingredient, formulation and route: A specific combination capsule containing lutein 20 mg, zeaxanthin 4 mg, curcuminoids 200 mg and vitamin D3 600 IU. Batch/detailed composition and actual individual exposure/adherence are unverified. Do not isolate ingredient effects, generalize to other combinations or create new conversions, consumption guidance, product recommendations or treatment instructions.
Dose: Preserve the original eight-week/day-56 scope in 2021 and day-56 results in 2024 separately. Identical exposure/completion for all participants, individual adherence/discontinuation, other durations/doses and post-discontinuation durability are unverified.
Comparator: In 2021, 30 participants received an appearance-matched soybean-oil placebo and 30 the product. Detailed formulation/sensory matching, actual exposure/adherence and allocation/role-specific blinding in the 2024 multicenter double-blind placebo-controlled trial are unverified. Keep staff/support relationships and concurrent eye care/artificial-tear use separate for each trial.
Measured outcome: The selected day-56 coprimary outcomes are Schirmer tear volume and OSDI symptoms. Preserve 2021 OSDI values: product 30.10±4.88→17.09±4.85, placebo 32.54±5.06→31.00±7.18, between-group P=.0001; Schirmer between-group P<.0001. No new changes, between-group differences or CIs are calculated. Group-specific Schirmer values in mm, test/assessed-eye details, the meaning of ±, original models and denominators are unverified; between-group 95% CIs and prespecified clinically important thresholds remain originally unreported/unverified. The 2024 improvements in both outcomes, P<.001, and artificial-tear use, P=.562, are separate outcomes/estimands.
Duration: Distinguish original day-56/eight-week follow-up from actual visits, observations and exposure. Repeated/intermediate results, individual completion/discontinuation, post-discontinuation durability and long-term function/harms are unverified.
Questions outside this scope: Calculating new OSDI changes, between-group differences, response rates or CIs from baseline/final ± values, P values or denominators; Mixing OSDI/Schirmer measures, assessed eyes, denominators/times from the two trials into one estimand, or changing artificial-tear P=.562 into a benefit; Isolating/generalizing a four-ingredient combination result to individual ingredients, other formulations or long-term functional/disease effects; Adding 60/59, 155/116, groups/centers, eyes/measures/time points, reports or sibling tables as new independent trials or participants; Certifying another report or multiple centers in the same company lineage as current replication by independent investigators/funders; Merging support/manufacturing/supply/development, employee/advisory/writing/publication relationships, or confirming individually unverified disclosures/safety; Inheriting parent scores/axes, historical cross-checks or original narratives as subclaim scores, current review or external reading; New calculations, invented numbers, effects/CIs, grades, independence certification, or instructions for testing/biopsy/cancer-treatment selection, product consumption, eye care or treatment

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.

S01 · Radkar P et al. 2021

PubMed

Material type: Double-blind placebo-controlled randomized trial
Materials actually read: Summary read; external material unread
Findings recorded in the stored summary: OSDI between-group P=0.0001; Schirmer between-group P<0.0001; 95% CI not reported; grade C. In the 60-participant trial, day-56 OSDI changed from 30.10±4.88 to 17.09±4.85 in the product group and from 32.54±5.06 to 31.00±7.18 in the placebo group, with between-group P=0.0001. Schirmer tear volume also increased more with the product, P<0.0001. Both coprimary endpoints were positive, in a small eight-week manufacturer-supported trial. Distinguish the preserved summary narrative from unverified report-specific measurement/denominator, CI and plan details; no new effects, calculations or independence claims are created.
Record level: Outcome wording in the stored summary
Study overlap and independent replication: S01 Radkar 2021 was a single-center Indian trial in 60 randomized adults with mild/moderate dry eye, allocated 30/30, with 59 complete-case participants, over eight weeks/day 56. Distinguish original coprimary Schirmer/OSDI results for the specific four-ingredient capsule versus appearance-matched soybean-oil placebo. Original OSDI values are product 30.10±4.88→17.09±4.85 and placebo 32.54±5.06→31.00±7.18, P=.0001; Schirmer P<.0001. No new changes, between-group differences or CIs are calculated. Preserve original nonreporting of between-group 95% CIs/prespecified clinically important thresholds and concurrent-management/observation gaps. Link both reports through the original shared company development/funding narrative and historical R1/I0; do not certify current independence. Distinguish trial-specific support/manufacturing/development, company/employee/advisory authors and writing/publication roles. Do not add groups, centers, people/eyes, measures/time points, reports or sibling tables as new independent trials/participants. Report/material-slot counts are not totals of unique clinical trials, participants or independent replications; no new combined counts or independence certification is performed. S02, the 2024 four-center US follow-up trial, preserves the existing evidence-list record of 155 randomized, 116 analyzed, NCT05481450, and day-56 Schirmer/OSDI improvement versus placebo, P<.001. Do not transfer the representative trial’s 60/59 participants or group-specific OSDI values to this trial, or count artificial-tear use P=.562 as a benefit. Detailed group denominators, exact estimates/CIs, observations/missingness and hierarchy are unverified. Link both reports through the original shared company development/funding narrative and historical R1/I0; do not certify current independence. Distinguish trial-specific support/manufacturing/development, company/employee/advisory authors and writing/publication roles. Do not add groups, centers, people/eyes, measures/time points, reports or sibling tables as new independent trials/participants. Report/material-slot counts are not totals of unique clinical trials, participants or independent replications; no new combined counts or independence certification is performed.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Stored file	Stored summary	Summary read	Only stored-summary and bibliographic content was used for production. External material verification/review is not complete.
External paper	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Registration material	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Protocol	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Statistical analysis plan	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Funding, product-support and COI material	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.

S02 · 2024 four-center US follow-up trial

PubMed

Material type: Multicenter double-blind placebo-controlled randomized trial
Materials actually read: Summary read; external material unread
Findings recorded in the stored summary: Both improved versus placebo (P<0.001); artificial-tear use P=0.562. The 2024 four-center US follow-up trial, NCT05481450, similarly reported improved day-56 Schirmer and OSDI versus placebo (P<0.001). OmniActive Health Technologies supported trial costs; Bausch + Lomb Inc. provided publication fees and medical-writing/editorial support. Authors AM, DR and MP were OmniActive employees; RR and KB were Bausch + Lomb employees; NG, JG, JP and LP were Bausch + Lomb advisory-board members. The two trials share a funding lineage and are not independent replication by different investigators/funders. Follow-up artificial-tear use had a null between-group result, P=0.562, and was not counted as a benefit. Distinguish the preserved summary narrative from unverified report-specific measurement/denominator, CI and plan details; no new effects, calculations or independence claims are created.
Record level: Outcome wording in the stored summary
Study overlap and independent replication: S01 Radkar 2021 was a single-center Indian trial in 60 randomized adults with mild/moderate dry eye, allocated 30/30, with 59 complete-case participants, over eight weeks/day 56. Distinguish original coprimary Schirmer/OSDI results for the specific four-ingredient capsule versus appearance-matched soybean-oil placebo. Original OSDI values are product 30.10±4.88→17.09±4.85 and placebo 32.54±5.06→31.00±7.18, P=.0001; Schirmer P<.0001. No new changes, between-group differences or CIs are calculated. Preserve original nonreporting of between-group 95% CIs/prespecified clinically important thresholds and concurrent-management/observation gaps. Link both reports through the original shared company development/funding narrative and historical R1/I0; do not certify current independence. Distinguish trial-specific support/manufacturing/development, company/employee/advisory authors and writing/publication roles. Do not add groups, centers, people/eyes, measures/time points, reports or sibling tables as new independent trials/participants. Report/material-slot counts are not totals of unique clinical trials, participants or independent replications; no new combined counts or independence certification is performed. S02, the 2024 four-center US follow-up trial, preserves the existing evidence-list record of 155 randomized, 116 analyzed, NCT05481450, and day-56 Schirmer/OSDI improvement versus placebo, P<.001. Do not transfer the representative trial’s 60/59 participants or group-specific OSDI values to this trial, or count artificial-tear use P=.562 as a benefit. Detailed group denominators, exact estimates/CIs, observations/missingness and hierarchy are unverified. Link both reports through the original shared company development/funding narrative and historical R1/I0; do not certify current independence. Distinguish trial-specific support/manufacturing/development, company/employee/advisory authors and writing/publication roles. Do not add groups, centers, people/eyes, measures/time points, reports or sibling tables as new independent trials/participants. Report/material-slot counts are not totals of unique clinical trials, participants or independent replications; no new combined counts or independence certification is performed.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Stored file	Stored summary	Summary read	Only stored-summary and bibliographic content was used for production. External material verification/review is not complete.
External paper	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Registration material	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Protocol	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Statistical analysis plan	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Funding, product-support and COI material	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.

Report counts versus independent study counts

S01 Radkar 2021 was a single-center Indian trial in 60 randomized adults with mild/moderate dry eye, allocated 30/30, with 59 complete-case participants, over eight weeks/day 56. Distinguish original coprimary Schirmer/OSDI results for the specific four-ingredient capsule versus appearance-matched soybean-oil placebo. Original OSDI values are product 30.10±4.88→17.09±4.85 and placebo 32.54±5.06→31.00±7.18, P=.0001; Schirmer P<.0001. No new changes, between-group differences or CIs are calculated. Preserve original nonreporting of between-group 95% CIs/prespecified clinically important thresholds and concurrent-management/observation gaps. Link both reports through the original shared company development/funding narrative and historical R1/I0; do not certify current independence. Distinguish trial-specific support/manufacturing/development, company/employee/advisory authors and writing/publication roles. Do not add groups, centers, people/eyes, measures/time points, reports or sibling tables as new independent trials/participants. Report/material-slot counts are not totals of unique clinical trials, participants or independent replications; no new combined counts or independence certification is performed. S02, the 2024 four-center US follow-up trial, preserves the existing evidence-list record of 155 randomized, 116 analyzed, NCT05481450, and day-56 Schirmer/OSDI improvement versus placebo, P<.001. Do not transfer the representative trial’s 60/59 participants or group-specific OSDI values to this trial, or count artificial-tear use P=.562 as a benefit. Detailed group denominators, exact estimates/CIs, observations/missingness and hierarchy are unverified. Link both reports through the original shared company development/funding narrative and historical R1/I0; do not certify current independence. Distinguish trial-specific support/manufacturing/development, company/employee/advisory authors and writing/publication roles. Do not add groups, centers, people/eyes, measures/time points, reports or sibling tables as new independent trials/participants. Report/material-slot counts are not totals of unique clinical trials, participants or independent replications; no new combined counts or independence certification is performed.

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 · Selected day-56 coprimary results and original values

Required materials and conditions: Original question, grade/note, parent context and absent fields
Conditions for verification: Original question, grade/note, parent context and absent fields requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Original question, grade/note, parent context and absent fields to connect materials needed for the selected question with the current materials in this production item.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are custom design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design

N02 · Population with mild-to-moderate dry eye

Required materials and conditions: Recruitment, disease/baseline conditions and group characteristics
Conditions for verification: Recruitment, disease/baseline conditions and group characteristics requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Recruitment, disease/baseline conditions and group characteristics to connect materials needed for the selected question with the current materials in this production item.
Referenced methods: M03 §3.2.1; detailed population conditions are custom design; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are custom design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design

N03 · Fixed four-ingredient combination capsule

Required materials and conditions: Ingredient combination, formulation/dose and product identity
Conditions for verification: Ingredient combination, formulation/dose and product identity requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Ingredient combination, formulation/dose and product identity to connect materials needed for the selected question with the current materials in this production item.
Referenced methods: M03 §3.2.2–3.2.3; reverse-direction labels and checking adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed

N04 · Visually matched soybean-oil placebo

Required materials and conditions: Comparator formulation, sensory matching and concurrent exposure
Conditions for verification: Comparator formulation, sensory matching and concurrent exposure requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Comparator formulation, sensory matching and concurrent exposure to connect materials needed for the selected question with the current materials in this production item.
Referenced methods: M03 §§3.2.2–3.2.3; reverse-direction labels and test adaptation are Chamgap-designed; M08 Table 8.2.a and M03 §3.2.4; Chamgap adaptation; M03 §3.2.3 and M08 §§8.2.2–8.2.3; Chamgap adaptation

N05 · Day-56/eight-week exposure and follow-up

Required materials and conditions: Distinguish exposure period, visits/measurement and actual completion
Conditions for verification: Distinguish exposure period, visits/measurement and actual completion requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Distinguish exposure period, visits/measurement and actual completion to connect materials needed for the selected question with the current materials in this production item.
Referenced methods: M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed; M03 §3.2.3 and M08 §§8.2.2–8.2.3; Chamgap adaptation; M03 §§3.2.1–3.2.4; dose, durability and effect-modification details are Chamgap-designed

N06 · Randomization and blinding procedures

Required materials and conditions: Allocation/concealment and participant, measurement, assessment and analysis roles
Conditions for verification: Allocation/concealment and participant, measurement, assessment and analysis roles requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Allocation/concealment and participant, measurement, assessment and analysis roles to connect materials needed for the selected question with the current materials in this production item.
Referenced methods: M08 §§8.1–8.2.3; Chamgap adaptation; M08 Table 8.2.a and M03 §3.2.4; Chamgap adaptation; M04 §§4.5–4.6 material collection/selection principles; access/reading separation and hyperlink rules are Chamgap-designed

N07 · 2021: 60 randomized and 59 complete cases

Required materials and conditions: Randomized/observed/analyzed denominators, omissions and missingness
Conditions for verification: Randomized/observed/analyzed denominators, omissions and missingness requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Randomized/observed/analyzed denominators, omissions and missingness to connect materials needed for the selected question with the current materials in this production item.
Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design; M08 §8.2.2, M15 §15.3.1; custom application; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is a custom application

N08 · Original baseline and final OSDI values

Required materials and conditions: Group OSDI timing, units, estimates and variability
Conditions for verification: Group OSDI timing, units, estimates and variability requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Group OSDI timing, units, estimates and variability to connect materials needed for the selected question with the current materials in this production item.
Referenced methods: M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed; M08 Table 8.2.a and M03 §3.2.4; Chamgap adaptation; M08 §8.2.2 and M15 §15.3.1; Chamgap adaptation; M15 §§15.3.1–15.3.3; Chamgap adaptation; M08 Table 8.2.a, M15 §15.3 and M19 §§19.1.2–19.2.4; design-specific adaptation is Chamgap-designed

N09 · OSDI between-group P value and precision

Required materials and conditions: Selected between-group estimate/CI, test and model
Conditions for verification: Selected between-group estimate/CI, test and model requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Selected between-group estimate/CI, test and model to connect materials needed for the selected question with the current materials in this production item.
Referenced methods: M15 §§15.3.1–15.3.3; Chamgap adaptation; M08 §8.2.2 and M15 §15.3.1; Chamgap adaptation; M08 Table 8.2.a, M15 §15.3 and M19 §§19.1.2–19.2.4; design-specific adaptation is Chamgap-designed; M08 Table 8.2.a and M04 §4.6.3; Chamgap adaptation

N10 · Schirmer tear volume and measurement

Required materials and conditions: Tear-volume definition/units, test conditions and assessed eyes
Conditions for verification: Tear-volume definition/units, test conditions and assessed eyes requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Tear-volume definition/units, test conditions and assessed eyes to connect materials needed for the selected question with the current materials in this production item.
Referenced methods: M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed; M08 Table 8.2.a and M03 §3.2.4; Chamgap adaptation; M15 §§15.3.1–15.3.3; Chamgap adaptation; M08 Table 8.2.a, M15 §15.3 and M19 §§19.1.2–19.2.4; design-specific adaptation is Chamgap-designed

N11 · Coprimary outcomes, multiplicity and hierarchy

Required materials and conditions: Success rules for two prespecified endpoints and multiple comparisons/time points
Conditions for verification: Success rules for two prespecified endpoints and multiple comparisons/time points requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Success rules for two prespecified endpoints and multiple comparisons/time points to connect materials needed for the selected question with the current materials in this production item.
Referenced methods: M08 Table 8.2.a and M04 §4.6.3; Chamgap adaptation; M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed; M04 §§4.5–4.6 material collection/selection principles; access/reading separation and hyperlink rules are Chamgap-designed

N12 · CIs and prespecified importance thresholds

Required materials and conditions: Separate evidence for group CIs and clinical importance
Conditions for verification: Separate evidence for group CIs and clinical importance requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Separate evidence for group CIs and clinical importance to connect materials needed for the selected question with the current materials in this production item.
Referenced methods: M15 §§15.3.1–15.3.3; Chamgap adaptation; M08 Table 8.2.a and M04 §4.6.3; Chamgap adaptation; M08 Table 8.2.a, M15 §15.3 and M19 §§19.1.2–19.2.4; design-specific adaptation is Chamgap-designed; M04 §§4.5–4.6 material collection/selection principles; access/reading separation and hyperlink rules are Chamgap-designed

N13 · 2024: four centers, 155 randomized and 116 analyzed

Required materials and conditions: Follow-up-trial population, denominators, analysis and exclusions
Conditions for verification: Follow-up-trial population, denominators, analysis and exclusions requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Follow-up-trial population, denominators, analysis and exclusions to connect materials needed for the selected question with the current materials in this production item.
Referenced methods: M03 §3.2.1; detailed population conditions are Chamgap-designed; M08 Table 8.2.a, M15 §15.3 and M19 §§19.1.2–19.2.4; design-specific adaptation is Chamgap-designed; M08 §8.2.2 and M15 §15.3.1; Chamgap adaptation; M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations

N14 · 2024 Schirmer/OSDI

Required materials and conditions: Original group results for each measure and correspondence to its trial
Conditions for verification: Original group results for each measure and correspondence to its trial requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Original group results for each measure and correspondence to its trial to connect materials needed for the selected question with the current materials in this production item.
Referenced methods: M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed; M08 Table 8.2.a and M03 §3.2.4; Chamgap adaptation; M15 §§15.3.1–15.3.3; Chamgap adaptation; M08 Table 8.2.a and M04 §4.6.3; Chamgap adaptation

N15 · Artificial-tear use: P=.562, a separate outcome

Required materials and conditions: Use-outcome definition/timing, denominators and estimates
Conditions for verification: Use-outcome definition/timing, denominators and estimates requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Use-outcome definition/timing, denominators and estimates to connect materials needed for the selected question with the current materials in this production item.
Referenced methods: M04 §4.6.3 and M15 §§15.3.1–15.3.3; status separation is Chamgap-designed; M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed; M15 §§15.3.1–15.3.3; Chamgap adaptation; M08 Table 8.2.a and M04 §4.6.3; Chamgap adaptation

N16 · CTRI and NCT registration records

Required materials and conditions: Trial registration, original plans/changes and report correspondence
Conditions for verification: Trial registration, original plans/changes and report correspondence requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Trial registration, original plans/changes and report correspondence to connect materials needed for the selected question with the current materials in this production item.
Referenced methods: M08 Table 8.2.a, M04 §4.6.3; custom application; M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design

N17 · Concurrent eye care and adherence

Required materials and conditions: Artificial tears/treatment, lifestyle/products and actual exposure
Conditions for verification: Artificial tears/treatment, lifestyle/products and actual exposure requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Artificial tears/treatment, lifestyle/products and actual exposure to connect materials needed for the selected question with the current materials in this production item.
Referenced methods: M03 §3.2.3, M08 §8.2.2–8.2.3; custom application; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptation are custom design; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are custom design

N18 · 2021 support, product supply and development

Required materials and conditions: Distinguish research funding, manufacturing/supply, development and other support
Conditions for verification: Distinguish research funding, manufacturing/supply, development and other support requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Distinguish research funding, manufacturing/supply, development and other support to connect materials needed for the selected question with the current materials in this production item.
Referenced methods: Chamgap independence/attribution conditions. The formal methods sections in this pilot do not certify all these details; M03 §§3.2.2–3.2.3; reverse-direction labels and test adaptation are Chamgap-designed; M04 §§4.5–4.6 material collection/selection principles; access/reading separation and hyperlink rules are Chamgap-designed

N19 · 2021: four employee authors

Required materials and conditions: Author-specific employment/affiliation, contributions and COI
Conditions for verification: Author-specific employment/affiliation, contributions and COI requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Author-specific employment/affiliation, contributions and COI to connect materials needed for the selected question with the current materials in this production item.
Referenced methods: Chamgap’s own independence/attribution conditions; official methodology sections in this pilot do not certify all these detailed items; M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design

N20 · 2024 trial funding and publication/writing support

Required materials and conditions: Institution-specific trial/publication, writing and editorial roles
Conditions for verification: Institution-specific trial/publication, writing and editorial roles requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Institution-specific trial/publication, writing and editorial roles to connect materials needed for the selected question with the current materials in this production item.
Referenced methods: Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design

N21 · 2024 employees and advisory-board members

Required materials and conditions: Author/institution employment, advisory roles, contributions and COI
Conditions for verification: Author/institution employment, advisory roles, contributions and COI requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Author/institution employment, advisory roles, contributions and COI to connect materials needed for the selected question with the current materials in this production item.
Referenced methods: Chamgap’s own independence/attribution conditions; official methodology sections in this pilot do not certify all these detailed items; M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design

N22 · Same company lineage and independence

Required materials and conditions: Distinguish two trials/reports, company development/funding and replication
Conditions for verification: Distinguish two trials/reports, company development/funding and replication requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Distinguish two trials/reports, company development/funding and replication to connect materials needed for the selected question with the current materials in this production item.
Referenced methods: M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations; M04 §§4.6.1–4.6.2 and M15 §15.3.1; Chamgap adaptation; Chamgap independence/attribution conditions. The formal methods sections in this pilot do not certify all these details; M04 §§4.5 and 4.6.3; limits of the current material conversion follow the review scope and Chamgap design

N23 · People/eyes, measures and timing totals

Required materials and conditions: Report-trial-person/eye-endpoint duplication and relationships
Conditions for verification: Report-trial-person/eye-endpoint duplication and relationships requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Report-trial-person/eye-endpoint duplication and relationships to connect materials needed for the selected question with the current materials in this production item.
Referenced methods: M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations; M08 Table 8.2.a, M15 §15.3 and M19 §§19.1.2–19.2.4; design-specific adaptation is Chamgap-designed; M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed

N24 · Harm collection and nonreporting scope

Required materials and conditions: Safety populations, collection/examinations and group events/denominators
Conditions for verification: Safety populations, collection/examinations and group events/denominators requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Requirement and applicability: Supplementary
Application exceptions: Supplement safety-material gaps for the selected subclaim. Do not judge safety from detection, tear/symptom results or parent safety wording, or generate harm rates or new use instructions.
Why this condition is needed: Distinguish Safety populations, collection/examinations and group events/denominators to connect materials needed for the selected question with the current materials in this production item.
Referenced methods: M19 §19.1.2–19.2.4; detailed distinctions are custom design; M19 §19.1.2–19.2.4; custom application; M19 §19.1.2–19.2.4, M04 §4.6.3; custom application; M19 §19.1.2–19.2.4; custom application; M19 §19.1.2–19.2.4; custom application

N25 · Durability, individual ingredients and other formulations

Required materials and conditions: Application outside the selected blend, population and period
Conditions for verification: Application outside the selected blend, population and period requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Application outside the selected blend, population and period to connect materials needed for the selected question with the current materials in this production item.
Referenced methods: M03 §§3.2.2–3.2.3; reverse-direction labels and test adaptation are Chamgap-designed; M03 §§3.2.1–3.2.4; dose, durability and effect-modification details are Chamgap-designed; M03 §3.2.4; Chamgap extension boundary; M03 §3.2.1; detailed population conditions are Chamgap-designed

N26 · Original axes, Korean/English text, dates and corrections

Required materials and conditions: Distinguish subclaim/parent values, dates/corrections and history
Conditions for verification: Distinguish subclaim/parent values, dates/corrections and history requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Distinguish subclaim/parent values, dates/corrections and history to connect materials needed for the selected question with the current materials in this production item.
Referenced methods: M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed

N27 · Summary read; external material unread

Required materials and conditions: Material-specific actual reading, bibliography/URLs and additional-material gaps
Conditions for verification: Material-specific actual reading, bibliography/URLs and additional-material gaps requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Material-specific actual reading, bibliography/URLs and additional-material gaps to connect materials needed for the selected question with the current materials in this production item.
Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

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: Preserved method HTML copies; no current method-content re-review or official tool execution

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: Preserved method HTML copies; no current method-content re-review or official tool execution

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: Preserved method HTML copies; no current method-content re-review or official tool execution

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: Preserved method HTML copies; no current method-content re-review or official tool execution

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: Preserved method HTML copies; no current method-content re-review or official tool execution

What the statuses mean

Met: Status for necessary evidence confirmed after existing content review. No completion is declared in the current presentation.
Partly verified: Some information in the stored summary is linked into the table. External comparison/content review is not complete.
Unverified: The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.
Review incomplete: Existing content review remains incomplete.
Not reported: Not reported within the stored material actually read; not extended to the entire primary paper.
Inaccessible: Means an actual access failure. Access not attempted here is not assigned this state.
Not applicable: Not used as a substitute for an evidence gap.
Conflicting data: Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.
Insufficient evidence for the conditions: Marks a gap in additional material required by the selected conditions; not a new efficacy grade.

Change history

2026-10-12 · Public page/material version 1.0

Public pages and materials were prepared from the existing 27 items. No new clinical search, verification-status change or scoring was performed.

The stored-material review date (Not recorded) and original evidence cut-off (2026-08-26) were retained unchanged.

Researcher downloads

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

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N01 · Selected day-56 coprimary results and original values

Current findings: Retain subclaim C and its note for improved day-56 tear volume and OSDI. Parent C50 and axes are parent-assessment context.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Subclaim score/status/axes are absent and are not filled from parent values. Do not split/promote coprimary results into new subunits or grades. Content review remains incomplete.
Reason for missing information: Subclaim score/status/axes are absent and are not filled from parent values. Do not split/promote coprimary results into new subunits or grades.
Required materials and conditions: Original question, grade/note, parent context and absent fields
Materials to obtain first: Material distinguishing the selected row from the original parent assessment
Further research: Update research linking the original question with additional material; no new search, calculation or trial was performed here.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original question, grade/note, parent context and absent fields requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Why this condition is needed: Distinguish Original question, grade/note, parent context and absent fields to connect materials needed for the selected question with the current materials in this production item.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are custom design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design

Related sources S01 S02

N02 · Population with mild-to-moderate dry eye

Current findings: Retain the original 2021 Indian single-center population of 60 adults with mild-to-moderate dry eye, allocated 30/30.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Detailed eligibility, baseline symptoms/tears, age/comorbidity, group characteristics and correspondence with the 2024 population are unverified. Content review remains incomplete.
Reason for missing information: Detailed eligibility, baseline symptoms/tears, age/comorbidity, group characteristics and correspondence with the 2024 population are unverified.
Required materials and conditions: Recruitment, disease/baseline conditions and group characteristics
Materials to obtain first: Recruitment/eligibility and group baseline material for each trial
Further research: Further research on population-specific applicability and heterogeneity; no new search, calculation or trial was performed here.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Recruitment, disease/baseline conditions and group characteristics requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Why this condition is needed: Distinguish Recruitment, disease/baseline conditions and group characteristics to connect materials needed for the selected question with the current materials in this production item.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.1; detailed population conditions are custom design; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are custom design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design

Related sources S01 S02

N03 · Fixed four-ingredient combination capsule

Current findings: Retain lutein 20 mg, zeaxanthin 4 mg, curcuminoids 200 mg and vitamin D3 600 IU. Do not decompose results into individual-ingredient or other-blend effects.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Complete formulation/batch, additives/exposure, ingredient identity, actual product correspondence and adherence are unverified. No new conversion or use instructions. Content review remains incomplete.
Reason for missing information: Complete formulation/batch, additives/exposure, ingredient identity, actual product correspondence and adherence are unverified. No new conversion or use instructions.
Required materials and conditions: Ingredient combination, formulation/dose and product identity
Materials to obtain first: Product/batch, composition and actual exposure/quality material
Further research: Research distinguishing combination formulation from attribution of results; no new search, calculation or trial was performed here.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Ingredient combination, formulation/dose and product identity requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Why this condition is needed: Distinguish Ingredient combination, formulation/dose and product identity to connect materials needed for the selected question with the current materials in this production item.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.2–3.2.3; reverse-direction labels and checking adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed

Related sources S01 S02

N04 · Visually matched soybean-oil placebo

Current findings: The 2021 placebo was a visually matched soybean-oil capsule. The 2024 trial was also placebo-controlled, with detailed matching separately unverified.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Other ingredients/sensory features, group exposure, adherence/crossover and actual comparator conditions are unverified. Content review remains incomplete.
Reason for missing information: Other ingredients/sensory features, group exposure, adherence/crossover and actual comparator conditions are unverified.
Required materials and conditions: Comparator formulation, sensory matching and concurrent exposure
Materials to obtain first: Placebo/matching and actual exposure material for each trial
Further research: Research distinguishing comparator and measurement-condition differences; no new search, calculation or trial was performed here.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Comparator formulation, sensory matching and concurrent exposure requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Why this condition is needed: Distinguish Comparator formulation, sensory matching and concurrent exposure to connect materials needed for the selected question with the current materials in this production item.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §§3.2.2–3.2.3; reverse-direction labels and test adaptation are Chamgap-designed; M08 Table 8.2.a and M03 §3.2.4; Chamgap adaptation; M03 §3.2.3 and M08 §§8.2.2–8.2.3; Chamgap adaptation

Related sources S01 S02

N05 · Day-56/eight-week exposure and follow-up

Current findings: Retain eight-week/day-56 pivotal-trial and day-56 follow-up-trial results. Do not fill later durability or identical-duration exposure for all participants.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Individual starts/stopping, adherence, visit windows, repeated/intermediate results and later follow-up are unverified. Content review remains incomplete.
Reason for missing information: Individual starts/stopping, adherence, visit windows, repeated/intermediate results and later follow-up are unverified.
Required materials and conditions: Distinguish exposure period, visits/measurement and actual completion
Materials to obtain first: Visit/exposure, stopping/observation and follow-up material
Further research: Follow-up research on periods, timing and durability; no new search, calculation or trial was performed here.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Distinguish exposure period, visits/measurement and actual completion requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Why this condition is needed: Distinguish Distinguish exposure period, visits/measurement and actual completion to connect materials needed for the selected question with the current materials in this production item.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed; M03 §3.2.3 and M08 §§8.2.2–8.2.3; Chamgap adaptation; M03 §§3.2.1–3.2.4; dose, durability and effect-modification details are Chamgap-designed

Related sources S01 S02

N06 · Randomization and blinding procedures

Current findings: Retain double-blind placebo-controlled randomized designs in both original evidence records. The 2021 30/30 and 2024 155 participants are separate trial denominators.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Original sequence/concealment, role-specific blinding/maintenance and actual measurement/analysis procedures are unread. Design labels alone do not certify absence of bias. Content review remains incomplete.
Reason for missing information: Original sequence/concealment, role-specific blinding/maintenance and actual measurement/analysis procedures are unread. Design labels alone do not certify absence of bias.
Required materials and conditions: Allocation/concealment and participant, measurement, assessment and analysis roles
Materials to obtain first: Allocation, blinding/measurement and analysis records for each trial
Further research: Research on relationships between procedures and observed results; no new search, calculation or trial was performed here.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Allocation/concealment and participant, measurement, assessment and analysis roles requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Why this condition is needed: Distinguish Allocation/concealment and participant, measurement, assessment and analysis roles to connect materials needed for the selected question with the current materials in this production item.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 §§8.1–8.2.3; Chamgap adaptation; M08 Table 8.2.a and M03 §3.2.4; Chamgap adaptation; M04 §§4.5–4.6 material collection/selection principles; access/reading separation and hyperlink rules are Chamgap-designed

Related sources S01 S02

N07 · 2021: 60 randomized and 59 complete cases

Current findings: Retain 60 randomized, 30/30, and 59 in complete-case analysis. Do not calculate new missing/group-excluded counts or declare full ITT.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Group completion/omissions, reasons, endpoint-specific observations, models and missingness sensitivity are unverified. Content review remains incomplete.
Reason for missing information: Group completion/omissions, reasons, endpoint-specific observations, models and missingness sensitivity are unverified.
Required materials and conditions: Randomized/observed/analyzed denominators, omissions and missingness
Materials to obtain first: Group flow, observation/exclusion and missingness/sensitivity material
Further research: Further research on complete-case selection and omission assumptions; no new search, calculation or trial was performed here.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Randomized/observed/analyzed denominators, omissions and missingness requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Why this condition is needed: Distinguish Randomized/observed/analyzed denominators, omissions and missingness to connect materials needed for the selected question with the current materials in this production item.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design; M08 §8.2.2, M15 §15.3.1; custom application; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is a custom application

Related sources S01

N08 · Original baseline and final OSDI values

Current findings: Retain 2021 product 30.10±4.88→17.09±4.85 and placebo 32.54±5.06→31.00±7.18 as baseline/day-56 values. Do not calculate changes, group differences or response rates.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Scale/units, meaning of ±, observed/analyzed group denominators, models/adjustment and individual values are unverified. Content review remains incomplete.
Reason for missing information: Scale/units, meaning of ±, observed/analyzed group denominators, models/adjustment and individual values are unverified.
Required materials and conditions: Group OSDI timing, units, estimates and variability
Materials to obtain first: Original OSDI scale, group observation/variability and estimates
Further research: Research on baseline/final values, changes and between-group estimates; no new search, calculation or trial was performed here.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Group OSDI timing, units, estimates and variability requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Why this condition is needed: Distinguish Group OSDI timing, units, estimates and variability to connect materials needed for the selected question with the current materials in this production item.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed; M08 Table 8.2.a and M03 §3.2.4; Chamgap adaptation; M08 §8.2.2 and M15 §15.3.1; Chamgap adaptation; M15 §§15.3.1–15.3.3; Chamgap adaptation; M08 Table 8.2.a, M15 §15.3 and M19 §§19.1.2–19.2.4; design-specific adaptation is Chamgap-designed

Related sources S01

N09 · OSDI between-group P value and precision

Current findings: Retain 2021 between-group OSDI P=.0001. Do not derive new effects/CIs from group baseline/final numbers.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Exact group estimates/95% CIs, models/adjustment, prespecified important differences and test details are unverified or originally unreported. Content review remains incomplete.
Reason for missing information: Exact group estimates/95% CIs, models/adjustment, prespecified important differences and test details are unverified or originally unreported.
Required materials and conditions: Selected between-group estimate/CI, test and model
Materials to obtain first: Original OSDI models, group estimates/CIs and prespecified criteria
Further research: Research distinguishing precision from clinical meaning; no new search, calculation or trial was performed here.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Selected between-group estimate/CI, test and model requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Why this condition is needed: Distinguish Selected between-group estimate/CI, test and model to connect materials needed for the selected question with the current materials in this production item.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M15 §§15.3.1–15.3.3; Chamgap adaptation; M08 §8.2.2 and M15 §15.3.1; Chamgap adaptation; M08 Table 8.2.a, M15 §15.3 and M19 §§19.1.2–19.2.4; design-specific adaptation is Chamgap-designed; M08 Table 8.2.a and M04 §4.6.3; Chamgap adaptation

Related sources S01

N10 · Schirmer tear volume and measurement

Current findings: Schirmer is a different measure from OSDI symptoms. Retain 2021 between-group P<.0001.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Test conditions/methods, assessed eyes/repetitions, group mm values, observation denominators/models and precision are unverified. Do not transfer symptom values into tear volume. Content review remains incomplete.
Reason for missing information: Test conditions/methods, assessed eyes/repetitions, group mm values, observation denominators/models and precision are unverified. Do not transfer symptom values into tear volume.
Required materials and conditions: Tear-volume definition/units, test conditions and assessed eyes
Materials to obtain first: Original Schirmer measurement/eye, values/denominators and estimates
Further research: Research distinguishing objective tests from symptom outcomes; no new search, calculation or trial was performed here.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Tear-volume definition/units, test conditions and assessed eyes requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Why this condition is needed: Distinguish Tear-volume definition/units, test conditions and assessed eyes to connect materials needed for the selected question with the current materials in this production item.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed; M08 Table 8.2.a and M03 §3.2.4; Chamgap adaptation; M15 §§15.3.1–15.3.3; Chamgap adaptation; M08 Table 8.2.a, M15 §15.3 and M19 §§19.1.2–19.2.4; design-specific adaptation is Chamgap-designed

Related sources S01

N11 · Coprimary outcomes, multiplicity and hierarchy

Current findings: Retain the original note that day-56 Schirmer and OSDI coprimary outcomes were both positive. Do not change original coprimary_split=false or create sibling units.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Original registration/protocol/SAP, success criteria, all time points/outcomes, multiplicity, hierarchy and changes are unread. Content review remains incomplete.
Reason for missing information: Original registration/protocol/SAP, success criteria, all time points/outcomes, multiplicity, hierarchy and changes are unread.
Required materials and conditions: Success rules for two prespecified endpoints and multiple comparisons/time points
Materials to obtain first: Original plans, coprimary/multiplicity and all-results material
Further research: Research distinguishing prospective hierarchy from selected outcomes; no new search, calculation or trial was performed here.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Success rules for two prespecified endpoints and multiple comparisons/time points requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Why this condition is needed: Distinguish Success rules for two prespecified endpoints and multiple comparisons/time points to connect materials needed for the selected question with the current materials in this production item.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 Table 8.2.a and M04 §4.6.3; Chamgap adaptation; M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed; M04 §§4.5–4.6 material collection/selection principles; access/reading separation and hyperlink rules are Chamgap-designed

Related sources S01 S02

N12 · CIs and prespecified importance thresholds

Current findings: Retain historical wording that pivotal-trial tables lacked between-group 95% CIs and prespecified minimum clinically important Schirmer-mm/OSDI differences.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Exact estimates/original output, prespecified thresholds and follow-up-trial CIs/criteria are unverified. P values do not certify new CIs or clinical success. Content review remains incomplete.
Reason for missing information: Exact estimates/original output, prespecified thresholds and follow-up-trial CIs/criteria are unverified. P values do not certify new CIs or clinical success.
Required materials and conditions: Separate evidence for group CIs and clinical importance
Materials to obtain first: Original analyses/output, CIs and prespecified important-difference material
Further research: Research on statistical results, important differences and uncertainty; no new search, calculation or trial was performed here.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Separate evidence for group CIs and clinical importance requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Why this condition is needed: Distinguish Separate evidence for group CIs and clinical importance to connect materials needed for the selected question with the current materials in this production item.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M15 §§15.3.1–15.3.3; Chamgap adaptation; M08 Table 8.2.a and M04 §4.6.3; Chamgap adaptation; M08 Table 8.2.a, M15 §15.3 and M19 §§19.1.2–19.2.4; design-specific adaptation is Chamgap-designed; M04 §§4.5–4.6 material collection/selection principles; access/reading separation and hyperlink rules are Chamgap-designed

Related sources S01 S02

N13 · 2024: four centers, 155 randomized and 116 analyzed

Current findings: Retain the four-center US follow-up trial with 155 randomized and 116 analyzed. Do not sum these with pivotal-trial 60/59 or infer group denominators.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Group recruitment/allocation/observation, analysis criteria, attrition/missingness and endpoint denominators/models are unverified. Content review remains incomplete.
Reason for missing information: Group recruitment/allocation/observation, analysis criteria, attrition/missingness and endpoint denominators/models are unverified.
Required materials and conditions: Follow-up-trial population, denominators, analysis and exclusions
Materials to obtain first: Follow-up-trial group flow, analysis/missingness and baseline material
Further research: Research on analysis populations, omissions and follow-up results; no new search, calculation or trial was performed here.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Follow-up-trial population, denominators, analysis and exclusions requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Why this condition is needed: Distinguish Follow-up-trial population, denominators, analysis and exclusions to connect materials needed for the selected question with the current materials in this production item.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.1; detailed population conditions are Chamgap-designed; M08 Table 8.2.a, M15 §15.3 and M19 §§19.1.2–19.2.4; design-specific adaptation is Chamgap-designed; M08 §8.2.2 and M15 §15.3.1; Chamgap adaptation; M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations

Related sources S02

N14 · 2024 Schirmer/OSDI

Current findings: Retain original wording that follow-up day-56 Schirmer and OSDI both improved versus placebo, P<.001. Do not transfer 2021 group OSDI values/denominators to this trial.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Exact values/effects/CIs, models, assessed eyes/units, baseline/final/change and hierarchy are unverified. Content review remains incomplete.
Reason for missing information: Exact values/effects/CIs, models, assessed eyes/units, baseline/final/change and hierarchy are unverified.
Required materials and conditions: Original group results for each measure and correspondence to its trial
Materials to obtain first: Follow-up endpoint measurement/analysis, values/CIs and plans
Further research: Research distinguishing formulation-specific measures and populations; no new search, calculation or trial was performed here.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original group results for each measure and correspondence to its trial requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Why this condition is needed: Distinguish Original group results for each measure and correspondence to its trial to connect materials needed for the selected question with the current materials in this production item.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed; M08 Table 8.2.a and M03 §3.2.4; Chamgap adaptation; M15 §§15.3.1–15.3.3; Chamgap adaptation; M08 Table 8.2.a and M04 §4.6.3; Chamgap adaptation

Related sources S02

N15 · Artificial-tear use: P=.562, a separate outcome

Current findings: Retain original 2024 follow-up artificial-tear-use result described as null, between-group P=.562. Do not transfer Schirmer/OSDI positivity into reduced-use benefit.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Use measure, counts/people, baseline/follow-up, group values/denominators, CIs/models and hierarchy are unverified. No new zero-effect or equivalence claim. Content review remains incomplete.
Reason for missing information: Use measure, counts/people, baseline/follow-up, group values/denominators, CIs/models and hierarchy are unverified. No new zero-effect or equivalence claim.
Required materials and conditions: Use-outcome definition/timing, denominators and estimates
Materials to obtain first: Artificial-tear use/concurrent exposure and original estimates/denominators/plans
Further research: Research distinguishing other outcomes from uncertainty; no new search, calculation or trial was performed here.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Use-outcome definition/timing, denominators and estimates requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Why this condition is needed: Distinguish Use-outcome definition/timing, denominators and estimates to connect materials needed for the selected question with the current materials in this production item.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M04 §4.6.3 and M15 §§15.3.1–15.3.3; status separation is Chamgap-designed; M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed; M15 §§15.3.1–15.3.3; Chamgap adaptation; M08 Table 8.2.a and M04 §4.6.3; Chamgap adaptation

Related sources S02

N16 · CTRI and NCT registration records

Current findings: Retain 2021 CTRI/2021/01/030493 and 2024 NCT05481450. Do not promote existence, prospective timing or correspondence into original-material reading performed here.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Registration history, protocol/SAP, recruitment/analysis timing, multiplicity and changes are unread. Content review remains incomplete.
Reason for missing information: Registration history, protocol/SAP, recruitment/analysis timing, multiplicity and changes are unread.
Required materials and conditions: Trial registration, original plans/changes and report correspondence
Materials to obtain first: Registration/plans, changes and report correspondence for each trial
Further research: Research connecting prospective plans to reports; no new search, calculation or trial was performed here.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Trial registration, original plans/changes and report correspondence requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Why this condition is needed: Distinguish Trial registration, original plans/changes and report correspondence to connect materials needed for the selected question with the current materials in this production item.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 Table 8.2.a, M04 §4.6.3; custom application; M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design

Related sources S01 S02

N17 · Concurrent eye care and adherence

Current findings: Retain original scope of the particular blend versus placebo. Keep follow-up artificial-tear results as a separate endpoint/concurrent-exposure context.
Verification status: Unverified
Materials actually read: Summary read; external material unread
Why unverified: Information currently needed is unverified in the preserved summary. Other eye treatments/products, testing/environment, actual adherence/crossover/changes and artificial-tear-use records are unverified. No new management/treatment/consumption instructions. Content review remains incomplete.
Reason for missing information: Other eye treatments/products, testing/environment, actual adherence/crossover/changes and artificial-tear-use records are unverified. No new management/treatment/consumption instructions.
Required materials and conditions: Artificial tears/treatment, lifestyle/products and actual exposure
Materials to obtain first: Group concurrent exposure/management, adherence and use/change records
Further research: Research on concurrent exposure and attribution of blend results; no new search, calculation or trial was performed here.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Artificial tears/treatment, lifestyle/products and actual exposure requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Why this condition is needed: Distinguish Artificial tears/treatment, lifestyle/products and actual exposure to connect materials needed for the selected question with the current materials in this production item.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.3, M08 §8.2.2–8.2.3; custom application; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptation are custom design; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are custom design

Related sources S01 S02

N18 · 2021 support, product supply and development

Current findings: Retain original OmniActive study support, manufacturing/supply of product/matched placebo and participation in formulation development.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Contracts/amounts, supply/cost details, analysis/writing/publication costs and roles/disclosures are unread. Supply facts do not fill support details. Content review remains incomplete.
Reason for missing information: Contracts/amounts, supply/cost details, analysis/writing/publication costs and roles/disclosures are unread. Supply facts do not fill support details.
Required materials and conditions: Distinguish research funding, manufacturing/supply, development and other support
Materials to obtain first: Original 2021 support, product/development and analysis/writing/publication disclosures
Further research: Research on individual support/roles and report relationships; no new search, calculation or trial was performed here.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Distinguish research funding, manufacturing/supply, development and other support requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Why this condition is needed: Distinguish Distinguish research funding, manufacturing/supply, development and other support to connect materials needed for the selected question with the current materials in this production item.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: Chamgap independence/attribution conditions. The formal methods sections in this pilot do not certify all these details; M03 §§3.2.2–3.2.3; reverse-direction labels and test adaptation are Chamgap-designed; M04 §§4.5–4.6 material collection/selection principles; access/reading separation and hyperlink rules are Chamgap-designed

Related sources S01

N19 · 2021: four employee authors

Current findings: Retain original Korean/English wording that Priyanka Radkar, Abhijeet Morde, Deshanie Rai and Muralidhara Padigaru were OmniActive-affiliated/employed.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Author contributions, employment timing/equity, other COI and analysis/writing roles are unread. Current affiliation/independence is not certified. Content review remains incomplete.
Reason for missing information: Author contributions, employment timing/equity, other COI and analysis/writing roles are unread. Current affiliation/independence is not certified.
Required materials and conditions: Author-specific employment/affiliation, contributions and COI
Materials to obtain first: Author-specific affiliation/employment, contribution and COI disclosures
Further research: Research on author relationships and results-reporting roles; no new search, calculation or trial was performed here.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Author-specific employment/affiliation, contributions and COI requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Why this condition is needed: Distinguish Author-specific employment/affiliation, contributions and COI to connect materials needed for the selected question with the current materials in this production item.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: Chamgap’s own independence/attribution conditions; official methodology sections in this pilot do not certify all these detailed items; M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design

Related sources S01

N20 · 2024 trial funding and publication/writing support

Current findings: Retain wording that OmniActive funded the trial and Bausch + Lomb provided publication costs and medical-writing/editorial support.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Contracts, supply/analysis/data, writing contents/publication rights and other support/disclosures are unread. Do not merge 2021 roles or certify new independence. Content review remains incomplete.
Reason for missing information: Contracts, supply/analysis/data, writing contents/publication rights and other support/disclosures are unread. Do not merge 2021 roles or certify new independence.
Required materials and conditions: Institution-specific trial/publication, writing and editorial roles
Materials to obtain first: 2024 institution-specific funding, writing/editorial, publication and role material
Further research: Research on individual support and report relationships; no new search, calculation or trial was performed here.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Institution-specific trial/publication, writing and editorial roles requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Why this condition is needed: Distinguish Institution-specific trial/publication, writing and editorial roles to connect materials needed for the selected question with the current materials in this production item.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design

Related sources S02

N21 · 2024 employees and advisory-board members

Current findings: Retain original AM/DR/MP as OmniActive employees, RR/KB as Bausch + Lomb employees and NG/JG/JP/LP as Bausch + Lomb advisory-board members. Do not expand initials into new names.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Relationship timing, employment/contracts, contributions/equity, original COI and data/writing roles are unread. Content review remains incomplete.
Reason for missing information: Relationship timing, employment/contracts, contributions/equity, original COI and data/writing roles are unread.
Required materials and conditions: Author/institution employment, advisory roles, contributions and COI
Materials to obtain first: Original author affiliation/contribution, employment/advisory and COI material
Further research: Research on individual author/institution relationships and reports; no new search, calculation or trial was performed here.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Author/institution employment, advisory roles, contributions and COI requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Why this condition is needed: Distinguish Author/institution employment, advisory roles, contributions and COI to connect materials needed for the selected question with the current materials in this production item.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: Chamgap’s own independence/attribution conditions; official methodology sections in this pilot do not certify all these detailed items; M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design

Related sources S02

N22 · Same company lineage and independence

Current findings: Retain original R1/I0 context that both formulation reports share company development/funding lineage rather than replication by independent investigators/funders.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Actual trial/population/bibliographic correspondence, unique people/overlap and external independence comparison are unverified. Same-direction or multicenter findings do not certify new independence. Content review remains incomplete.
Reason for missing information: Actual trial/population/bibliographic correspondence, unique people/overlap and external independence comparison are unverified. Same-direction or multicenter findings do not certify new independence.
Required materials and conditions: Distinguish two trials/reports, company development/funding and replication
Materials to obtain first: Trial/report, formulation/population, funding/development relationships and separate evidence
Further research: Research distinguishing shared material/company lineage from separate replication; no new search, calculation or trial was performed here.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Distinguish two trials/reports, company development/funding and replication requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Why this condition is needed: Distinguish Distinguish two trials/reports, company development/funding and replication to connect materials needed for the selected question with the current materials in this production item.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations; M04 §§4.6.1–4.6.2 and M15 §15.3.1; Chamgap adaptation; Chamgap independence/attribution conditions. The formal methods sections in this pilot do not certify all these details; M04 §§4.5 and 4.6.3; limits of the current material conversion follow the review scope and Chamgap design

Related sources S01 S02

N23 · People/eyes, measures and timing totals

Current findings: Distinguish 2021 60/59, 2024 155/116, groups/centers, Schirmer/OSDI, timing and sibling sheets. Do not turn original people/analysis counts or eyes/measures into new independent-trial/participant totals.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Assessed eyes, repeated measurements/observations, person/measure correspondence and unique-person/trial totals were not externally compared. Content review remains incomplete.
Reason for missing information: Assessed eyes, repeated measurements/observations, person/measure correspondence and unique-person/trial totals were not externally compared.
Required materials and conditions: Report-trial-person/eye-endpoint duplication and relationships
Materials to obtain first: Trial/person/eye, observation/measure and report relationships
Further research: Research on measurement/reporting units and actual population relationships; no new search, calculation or trial was performed here.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Report-trial-person/eye-endpoint duplication and relationships requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Why this condition is needed: Distinguish Report-trial-person/eye-endpoint duplication and relationships to connect materials needed for the selected question with the current materials in this production item.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations; M08 Table 8.2.a, M15 §15.3 and M19 §§19.1.2–19.2.4; design-specific adaptation is Chamgap-designed; M03 §3.2.4 and M15 §§15.3.1–15.3.3; question-specific outcome adaptation is Chamgap-designed

Related sources S01 S02

N24 · Harm collection and nonreporting scope

Current findings: Retain original wording that hematology/chemistry, vital signs/physical examinations and adverse events were assessed, with safety problems/serious events unreported.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Trial/report-specific safety populations, periods, events/denominators, stopping/relatedness, omissions and long-term/vulnerable populations are unverified. Nonreporting is not all harms zero or safety certification. Content review remains incomplete.
Reason for missing information: Trial/report-specific safety populations, periods, events/denominators, stopping/relatedness, omissions and long-term/vulnerable populations are unverified. Nonreporting is not all harms zero or safety certification.
Required materials and conditions: Safety populations, collection/examinations and group events/denominators
Materials to obtain first: Trial-specific harm collection, group denominators/events and stopping/follow-up material
Further research: Research on harm-reporting scope and later follow-up material; no new search, calculation or trial was performed here.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Safety populations, collection/examinations and group events/denominators requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Why this condition is needed: Distinguish Safety populations, collection/examinations and group events/denominators to connect materials needed for the selected question with the current materials in this production item.
Application exceptions: Supplement safety-material gaps for the selected subclaim. Do not judge safety from detection, tear/symptom results or parent safety wording, or generate harm rates or new use instructions.
Referenced methods: M19 §19.1.2–19.2.4; detailed distinctions are custom design; M19 §19.1.2–19.2.4; custom application; M19 §19.1.2–19.2.4, M04 §4.6.3; custom application; M19 §19.1.2–19.2.4; custom application; M19 §19.1.2–19.2.4; custom application

Related sources S01 S02

N25 · Durability, individual ingredients and other formulations

Current findings: These are day-56 tear/symptom results for a fixed four-ingredient blend. Do not decompose/generalize to individual lutein/zeaxanthin/curcumin/vitamin D, other blends or long-term effects.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Individual ingredients/composition, other doses/populations, post-trial/long-term function/disease outcomes and harms are unverified. No product-selection/consumption/treatment instructions. Content review remains incomplete.
Reason for missing information: Individual ingredients/composition, other doses/populations, post-trial/long-term function/disease outcomes and harms are unverified. No product-selection/consumption/treatment instructions.
Required materials and conditions: Application outside the selected blend, population and period
Materials to obtain first: Additional material by formulation/population, duration/post-trial and long-term outcome
Further research: Research distinguishing combined attribution from other conditions; no new search, calculation or trial was performed here.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Application outside the selected blend, population and period requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Why this condition is needed: Distinguish Application outside the selected blend, population and period to connect materials needed for the selected question with the current materials in this production item.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §§3.2.2–3.2.3; reverse-direction labels and test adaptation are Chamgap-designed; M03 §§3.2.1–3.2.4; dose, durability and effect-modification details are Chamgap-designed; M03 §3.2.4; Chamgap extension boundary; M03 §3.2.1; detailed population conditions are Chamgap-designed

Related sources S01 S02

N26 · Original axes, Korean/English text, dates and corrections

Current findings: Complete original preservation retains subclaim C/note, parent C50/Good, B/S/R1/I0/E+/B2, precision null, three false flags, empty overrides, Korean/English, 2026-08-26 and empty corrections/deliberation.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. Historical cross-checks, original nonreporting and coprimary-success/independence wording are not current review, original-material reading or new condition fulfillment. Do not fill absent subclaim score/status/axes or parent classification keys. Content review remains incomplete.
Reason for missing information: Historical cross-checks, original nonreporting and coprimary-success/independence wording are not current review, original-material reading or new condition fulfillment. Do not fill absent subclaim score/status/axes or parent classification keys.
Required materials and conditions: Distinguish subclaim/parent values, dates/corrections and history
Materials to obtain first: Original assessment, corrections/changes and user observations
Further research: Research updating original-material changes and production versions; no new search, calculation or trial was performed here.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Distinguish subclaim/parent values, dates/corrections and history requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Why this condition is needed: Distinguish Distinguish subclaim/parent values, dates/corrections and history to connect materials needed for the selected question with the current materials in this production item.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed

Related sources S01 S02

N27 · Summary read; external material unread

Current findings: The preserved JSON summary was read for production and 2021/2024 bibliography/URLs connected. External papers, registration, protocol/SAP and original funding/COI disclosures remain unread and were not accessed.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only corresponding information in the preserved summary is recorded; detailed original materials are unread and content review remains incomplete. URLs/registration or historical wording do not upgrade external acquisition/reading or content-review states; no external click/link checks were performed. Content review remains incomplete.
Reason for missing information: URLs/registration or historical wording do not upgrade external acquisition/reading or content-review states; no external click/link checks were performed.
Required materials and conditions: Material-specific actual reading, bibliography/URLs and additional-material gaps
Materials to obtain first: Original reports/registration/plans, disclosures and user observations
Further research: Scope-specific update research based on material actually acquired; no new search, calculation or trial was performed here.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Material-specific actual reading, bibliography/URLs and additional-material gaps requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.
Why this condition is needed: Distinguish Material-specific actual reading, bibliography/URLs and additional-material gaps to connect materials needed for the selected question with the current materials in this production item.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

Related sources S01 S02