# Dry-eye combination capsule · Evidence Check for reduced artificial-tear use

Verdict 2957 · Evidence Check

Stored-material review date: Not recorded  
Original evidence cut-off: 2026-08-26  
Review-criteria version: 1.0  
Public page/material preparation date: 2026-10-12

Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect.

## Assessment scope

- Population: The selected result concerns the 2024 four-center US dry-eye follow-up: 155 randomized, 116 analyzed. The 2021 Indian representative trial in 60 adults with mild/moderate dry eye is separate context.
- Ingredient, formulation and route: Fixed lutein, zeaxanthin, curcumin and vitamin D3 combination capsule
- Dose: Preserved study combination: lutein 20 mg, zeaxanthin 4 mg, curcuminoids 200 mg and vitamin D3 600 IU. Trial-specific details are unread; this is not dosing guidance.
- Comparator: Follow-up placebo; the representative 2021 appearance-matched soybean-oil placebo is a separate specification.
- Measured outcome: Between-group artificial-tear-use outcome; use units, direct effects, CIs and observation windows unverified. Distinguish from Schirmer/OSDI.
- Duration: Both reports concern day 56/eight weeks; exact use-observation windows and post-discontinuation follow-up are unverified.
- Questions outside this scope: No new research, effects, CIs, calculations, assessments, independent certification, participant totals or product/drug-use/dosing/treatment or adjunct-treatment reduction/discontinuation guidance is created

## Checklist items

### N01 · What are the original wording and subclaim verdict for artificial-tear use?

Verification status: Partly verified  
Reading scope: Summary read; related external material unread

- Current findings: The original claim is reduced artificial-tear use, grade D, with the note that the follow-up between-group P=0.562. The parent is C with 50 points for tear volume/OSDI.
- Why unverified: Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment
- Reason for missing information: Selected-row score, status and axes are absent. Do not transfer parent C, 50 points or E+ into scores/effects for reduced artificial-tear use.
- Required materials and conditions: Distinguish selected-row grade/note from the parent verdict
- Materials to obtain first: Selected row and original parent assessment
- Further research: Present artificial-tear use separately from tear-volume/symptom verdicts
- Conditions for verification: Distinguish selected-row grade/note from the parent verdict; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification
- Why this condition is needed: Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint
- Application exceptions: Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units
- Remaining uncertainty: External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks
- Referenced methods: Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.
- Related sources: R01, R02

### N02 · Which trial directly reported the selected use outcome?

Verification status: Partly verified  
Reading scope: Summary read; related external material unread

- Current findings: Artificial-tear-use P=0.562 belongs to the 2024 four-center US follow-up. The 2021 representative trial treated Schirmer and OSDI as coprimary outcomes.
- Why unverified: Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment
- Reason for missing information: Do not copy positive 2021 P values or its 60-participant denominator as direct artificial-tear-use results. Use results in 2021 are unverified in the summary.
- Required materials and conditions: Trial-specific original outcomes for the 2021 representative and 2024 follow-up trials
- Materials to obtain first: Trial-specific original use, symptom and test-result tables
- Further research: Separate different trials of the same formulation and their direct outcomes
- Conditions for verification: Trial-specific original outcomes for the 2021 representative and 2024 follow-up trials; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification
- Why this condition is needed: Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint
- Application exceptions: Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units
- Remaining uncertainty: External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks
- Referenced methods: Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.
- Related sources: R01, R02

### N03 · Are the follow-up population and applicability verified?

Verification status: Partly verified  
Reading scope: Summary read; related external material unread

- Current findings: The 2024 four-center US follow-up records 155 randomized and 116 analyzed.
- Why unverified: Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment
- Reason for missing information: Detailed follow-up eligibility, severity, ages and baseline use are absent from the summary. Do not automatically copy 2021 Indian mild/moderate eligibility to the follow-up.
- Required materials and conditions: Follow-up dry-eye eligibility, baseline, severity and centers
- Materials to obtain first: Follow-up eligibility, baseline characteristics and center materials
- Further research: Show recruitment-population differences between 2021 and the follow-up
- Conditions for verification: Follow-up dry-eye eligibility, baseline, severity and centers; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification
- Why this condition is needed: Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint
- Application exceptions: Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units
- Remaining uncertainty: External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks
- Referenced methods: Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.
- Related sources: R02

### N04 · What are the study identity and ingredient combination?

Verification status: Partly verified  
Reading scope: Summary read; related external material unread

- Current findings: The preserved study capsule combines lutein 20 mg, zeaxanthin 4 mg, curcuminoids 200 mg and vitamin D3 600 IU; the follow-up is described as the same formulation.
- Why unverified: Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment
- Reason for missing information: This preserves study identity and is not dosing guidance. Exact products, batches and schedules in each trial are externally unread; do not isolate ingredient effects.
- Required materials and conditions: Fixed combination and product/exposure specifications for each trial
- Materials to obtain first: Trial-specific product, formulation and exposure specifications
- Further research: Distinguish the fixed finished product from individual-ingredient efficacy and other formulations
- Conditions for verification: Fixed combination and product/exposure specifications for each trial; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification
- Why this condition is needed: Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint
- Application exceptions: Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units
- Remaining uncertainty: External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks
- Referenced methods: Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.
- Related sources: R01, R02

### N05 · Are placebo composition and trial-specific comparators distinguished?

Verification status: Partly verified  
Reading scope: Summary read; related external material unread

- Current findings: The 2021 representative trial compared 30 appearance-matched soybean-oil placebo participants with 30 product participants. The follow-up was also double-blind and placebo-controlled.
- Why unverified: Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment
- Reason for missing information: Detailed follow-up placebo specifications, batches and blinding implementation are externally unread. Do not copy all representative-trial placebo conditions to the follow-up.
- Required materials and conditions: Active/placebo composition, appearance, exposure and blinding
- Materials to obtain first: Trial-specific placebo/active specifications and blinding materials
- Further research: Show actual comparator conditions separately for each trial
- Conditions for verification: Active/placebo composition, appearance, exposure and blinding; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification
- Why this condition is needed: Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint
- Application exceptions: Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units
- Remaining uncertainty: External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks
- Referenced methods: Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.
- Related sources: R01, R02

### N06 · What are the units and definition of artificial-tear use?

Verification status: Unverified  
Reading scope: Summary read; related external material unread

- Current findings: The preserved follow-up outcome only states artificial-tear use.
- Why unverified: Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment
- Reason for missing information: Exact units, denominators and assessment for drop counts, frequency, product volume, days of use or user proportion are absent from the summary. Do not invent units or a reduction amount.
- Required materials and conditions: Original definitions of frequency, volume, days, people or user proportion
- Materials to obtain first: Original use-outcome definition and collection tools
- Further research: Present use units, aggregation and person denominators
- Conditions for verification: Original definitions of frequency, volume, days, people or user proportion; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification
- Why this condition is needed: Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint
- Application exceptions: Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units
- Remaining uncertainty: External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks
- Referenced methods: Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.
- Related sources: R02

### N07 · Are baseline, group-specific final values and changes available?

Verification status: Unverified  
Reading scope: Summary read; related external material unread

- Current findings: The preserved information for the selected outcome is follow-up between-group P=0.562.
- Why unverified: Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment
- Reason for missing information: Group-specific use baseline, final values and changes are absent from the summary. Do not convert OSDI or Schirmer numbers into use quantities.
- Required materials and conditions: Group-specific original baseline, day-56 and change values for use
- Materials to obtain first: Original group-specific baseline/final/change tables for use
- Further research: Separate use quantities from values/changes in other outcomes
- Conditions for verification: Group-specific original baseline, day-56 and change values for use; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification
- Why this condition is needed: Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint
- Application exceptions: Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units
- Remaining uncertainty: External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks
- Referenced methods: Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.
- Related sources: R02

### N08 · Are between-group use effects and confidence intervals provided?

Verification status: Partly verified  
Reading scope: Summary read; related external material unread

- Current findings: The follow-up between-group use result, P=0.562, was described as null and was not counted as a benefit.
- Why unverified: Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment
- Reason for missing information: Exact between-group effect, direction, CI and effect scale are unverified. Do not turn the P value into zero effect, equivalence or no artificial-tear use at all.
- Required materials and conditions: Use differences, ratios, effect scales, CIs and tests
- Materials to obtain first: Direct comparative use effects and interval tables
- Further research: Present the original test alongside missing effects/intervals
- Conditions for verification: Use differences, ratios, effect scales, CIs and tests; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification
- Why this condition is needed: Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint
- Application exceptions: Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units
- Remaining uncertainty: External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks
- Referenced methods: Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.
- Related sources: R02

### N09 · What prespecified outcome hierarchy applies to use?

Verification status: Unverified  
Reading scope: Summary read; related external material unread

- Current findings: Preserved follow-up evidence lists Schirmer and OSDI outcomes and mentions artificial-tear use separately in its results.
- Why unverified: Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment
- Reason for missing information: Prespecified use hierarchy, analysis plans and multiplicity handling are unread. Do not transfer positive coprimary outcomes into planning/success for use.
- Required materials and conditions: Primary, secondary or exploratory use outcome, plans and multiplicity
- Materials to obtain first: Follow-up protocol, SAP and outcome list
- Further research: Distinguish primary/secondary/exploratory outcomes and the use-analysis hierarchy
- Conditions for verification: Primary, secondary or exploratory use outcome, plans and multiplicity; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification
- Why this condition is needed: Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint
- Application exceptions: Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units
- Remaining uncertainty: External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks
- Referenced methods: Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.
- Related sources: R02

### N10 · Are the measurement period and repeated units for use verified?

Verification status: Partly verified  
Reading scope: Summary read; related external material unread

- Current findings: Follow-up tear-volume/symptom assessments are recorded at day 56. Use appears in the same report, but its exact observation window is absent from the summary.
- Why unverified: Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment
- Reason for missing information: Do not turn day 56 into invented days of use, cumulative drop counts or observation denominators. Do not add repeated measurements, eyes or people.
- Required materials and conditions: Baseline/day-56 use observation windows, records and repeated-measure handling
- Materials to obtain first: Use-record schedules, observation windows and repeated-measure handling
- Further research: Distinguish report assessment timing from actual use-observation windows
- Conditions for verification: Baseline/day-56 use observation windows, records and repeated-measure handling; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification
- Why this condition is needed: Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint
- Application exceptions: Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units
- Remaining uncertainty: External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks
- Referenced methods: Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.
- Related sources: R02

### N11 · What policies governed permitted, rescue or changed artificial tears?

Verification status: Unverified  
Reading scope: Summary read; related external material unread

- Current findings: The summary provides a use comparison but lacks details of permission, rescue, prescribing or participant-choice policies.
- Why unverified: Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment
- Reason for missing information: Do not attribute use differences solely to the capsule or create artificial-tear reduction, discontinuation or replacement guidance.
- Required materials and conditions: Permitted adjunctive care, products, rescue, changes and recording rules in both groups
- Materials to obtain first: Follow-up artificial-tear/adjunctive-care rules and use tables
- Further research: Distinguish adjunctive-care policy/actual use from the scope of product effects
- Conditions for verification: Permitted adjunctive care, products, rescue, changes and recording rules in both groups; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification
- Why this condition is needed: Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint
- Application exceptions: Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units
- Remaining uncertainty: External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks
- Referenced methods: Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.
- Related sources: R02

### N12 · Are follow-up allocation, analysis and withdrawal denominators distinguished?

Verification status: Partly verified  
Reading scope: Summary read; related external material unread

- Current findings: Follow-up evidence records 155 randomized and 116 analyzed.
- Why unverified: Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment
- Reason for missing information: Do not label all 116 as completers, PP participants or the use-analysis denominator. Group denominators, reasons, missingness handling and use-outcome denominators are unverified; do not calculate their difference.
- Required materials and conditions: Group-specific flow and exclusion reasons for 155 randomized and 116 analyzed
- Materials to obtain first: Follow-up group-specific recruitment, analysis and use-outcome flow tables
- Further research: Show randomized, analyzed and use-observation denominators separately
- Conditions for verification: Group-specific flow and exclusion reasons for 155 randomized and 116 analyzed; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification
- Why this condition is needed: Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint
- Application exceptions: Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units
- Remaining uncertainty: External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks
- Referenced methods: Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.
- Related sources: R02

### N13 · Was representative-trial complete-case analysis transferred to the follow-up?

Verification status: Partly verified  
Reading scope: Summary read; related external material unread

- Current findings: In 2021, 60 were randomized (30/30) with 59 in complete-case analysis. The follow-up separately had 155 randomized and 116 analyzed.
- Why unverified: Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment
- Reason for missing information: Do not transfer 59/60, the complete-case approach or small eight-week-trial limitations as the exact follow-up analysis method. Do not add participants from the two trials.
- Required materials and conditions: Original/follow-up analysis populations, denominators and missingness
- Materials to obtain first: Participant-flow, analysis and missingness tables for both trials
- Further research: Distinguish each recruitment population and original analysis method
- Conditions for verification: Original/follow-up analysis populations, denominators and missingness; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification
- Why this condition is needed: Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint
- Application exceptions: Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units
- Remaining uncertainty: External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks
- Referenced methods: Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.
- Related sources: R01, R02

### N14 · What is the scope of randomization, concealment and blinded use measurement?

Verification status: Partly verified  
Reading scope: Summary read; related external material unread

- Current findings: The follow-up is recorded as a multicenter double-blind placebo-controlled randomized trial.
- Why unverified: Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment
- Reason for missing information: Sequence generation, allocation concealment, blinding of use-record assessment and baseline balance are unread. Do not certify the design name or parent B2 as current review.
- Required materials and conditions: Follow-up allocation, measurement, artificial-tear records and blinding
- Materials to obtain first: Follow-up allocation/concealment, use-record and assessment methods
- Further research: Distinguish design labels from actual implementation/use-measurement limitations
- Conditions for verification: Follow-up allocation, measurement, artificial-tear records and blinding; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification
- Why this condition is needed: Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint
- Application exceptions: Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units
- Remaining uncertainty: External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks
- Referenced methods: Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.
- Related sources: R02

### N15 · Do positive OSDI/Schirmer results mean reduced artificial-tear use?

Verification status: Partly verified  
Reading scope: Summary read; related external material unread

- Current findings: Representative-trial OSDI between-group P=0.0001 and Schirmer P<0.0001; both follow-up measures P<0.001. Artificial-tear use is separately null, P=0.562.
- Why unverified: Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment
- Reason for missing information: Do not transfer positive symptom/test results into benefits for reduced adjunctive care, treatment replacement or reduced use.
- Required materials and conditions: Outcome-specific direct results for symptoms, tear volume and adjunctive-care use
- Materials to obtain first: Outcome-specific original symptom, test and use tables
- Further research: Show distinct outcomes alongside the selected null result
- Conditions for verification: Outcome-specific direct results for symptoms, tear volume and adjunctive-care use; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification
- Why this condition is needed: Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint
- Application exceptions: Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units
- Remaining uncertainty: External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks
- Referenced methods: Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.
- Related sources: R01, R02

### N16 · Were representative OSDI baseline/final values converted into use quantities?

Verification status: Partly verified  
Reading scope: Summary read; related external material unread

- Current findings: Representative OSDI values are product 30.10±4.88→17.09±4.85 and placebo 32.54±5.06→31.00±7.18.
- Why unverified: Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment
- Reason for missing information: OSDI scores differ from artificial-tear drops, frequency or days. Do not calculate values, changes or between-group differences, or copy them as reduced use.
- Required materials and conditions: Distinguish scales/units and within-group/between-group estimands
- Materials to obtain first: Scale-specific original values, units and estimand materials
- Further research: Separate symptom scales from adjunctive-care use quantities
- Conditions for verification: Distinguish scales/units and within-group/between-group estimands; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification
- Why this condition is needed: Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint
- Application exceptions: Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units
- Remaining uncertainty: External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks
- Referenced methods: Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.
- Related sources: R01

### N17 · Are clinically important test/symptom differences and use-reduction thresholds the same?

Verification status: Partly verified  
Reading scope: Summary read; related external material unread

- Current findings: The original summary says prespecified clinically important Schirmer-mm/OSDI thresholds and tabled 95% CIs were absent.
- Why unverified: Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment
- Reason for missing information: Do not fill actual artificial-tear-use importance criteria or CIs with that statement. Use importance and original intervals are separately unverified.
- Required materials and conditions: Use-outcome importance/interpretation criteria and direct intervals
- Materials to obtain first: Use-importance criteria, plans and effect intervals
- Further research: Distinguish test/symptom thresholds from direct use-outcome criteria
- Conditions for verification: Use-outcome importance/interpretation criteria and direct intervals; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification
- Why this condition is needed: Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint
- Application exceptions: Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units
- Remaining uncertainty: External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks
- Referenced methods: Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.
- Related sources: R01, R02

### N18 · Are registration identifiers and external plans distinguished?

Verification status: Partly verified  
Reading scope: Summary read; related external material unread

- Current findings: The 2021 identifier is CTRI/2021/01/030493; the follow-up identifier is NCT05481450.
- Why unverified: Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment
- Reason for missing information: Original registrations, dates, amendment history and use plans are unread here. Do not merge the identifiers into one registration or independence certification.
- Required materials and conditions: Representative CTRI/follow-up NCT and trial-specific plans/history
- Materials to obtain first: Trial-specific registrations, protocols, SAPs and amendments
- Further research: Distinguish trial identifiers from actual reading/prespecified plans
- Conditions for verification: Representative CTRI/follow-up NCT and trial-specific plans/history; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification
- Why this condition is needed: Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint
- Application exceptions: Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units
- Remaining uncertainty: External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks
- Referenced methods: Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.
- Related sources: R01, R02

### N19 · Does the same-formulation follow-up mean the same participants or independent-company replication?

Verification status: Partly verified  
Reading scope: Summary read; related external material unread

- Current findings: The representative single-center Indian trial had 60 participants; the four-center US follow-up had 155 in a separate study population. The original narrative describes shared company development/funding and no replication by independent investigators/funders.
- Why unverified: Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment
- Reason for missing information: Do not merge the same formulation into one cohort or certify two reports as unique-trial/independent-replication counts. Confirmed trial/participant totals are null.
- Required materials and conditions: Trial populations, centers, reports, funding and investigator links
- Materials to obtain first: Report, registration, population and company-lineage links
- Further research: Distinguish separate recruitment populations from funding independence/replication scope
- Conditions for verification: Trial populations, centers, reports, funding and investigator links; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification
- Why this condition is needed: Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint
- Application exceptions: Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units
- Remaining uncertainty: External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks
- Referenced methods: Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.
- Related sources: R01, R02

### N20 · Was the fixed combination extended to single ingredients or other combinations?

Verification status: Partly verified  
Reading scope: Summary read; related external material unread

- Current findings: The original advertising interpretation concerns a fixed four-ingredient combination and says it cannot be extended to lutein, curcumin or vitamin D alone, or to other combinations.
- Why unverified: Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment
- Reason for missing information: Do not extend the selected artificial-tear null result into ingredient-specific zero effects or equivalence with other finished products.
- Required materials and conditions: Direct finished-product, ingredient and formulation comparisons
- Materials to obtain first: Direct ingredient/other-formulation comparisons
- Further research: Preserve the applicability of the fixed-combination question
- Conditions for verification: Direct finished-product, ingredient and formulation comparisons; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification
- Why this condition is needed: Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint
- Application exceptions: Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units
- Remaining uncertainty: External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks
- Referenced methods: Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.
- Related sources: R01, R02

### N21 · Does short-term use mean long-term adjunctive-care/disease-management benefit?

Verification status: Unverified  
Reading scope: Summary read; related external material unread

- Current findings: Both preserved trials concern day 56/eight weeks; the selected use result is null in the follow-up report.
- Why unverified: Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment
- Reason for missing information: Do not fill long-term reduced use, disease treatment, improved vision, treatment replacement or post-discontinuation durability with new claims.
- Required materials and conditions: Direct follow-up of post-discontinuation use, long-term symptoms and clinical outcomes
- Materials to obtain first: Long-term post-discontinuation adjunctive-care/clinical follow-up
- Further research: Distinguish short-term use/tests/symptoms from gaps in long-term direct outcomes
- Conditions for verification: Direct follow-up of post-discontinuation use, long-term symptoms and clinical outcomes; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification
- Why this condition is needed: Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint
- Application exceptions: Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units
- Remaining uncertainty: External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks
- Referenced methods: Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.
- Related sources: R01, R02

### N22 · Are representative-trial funding, products, formulation development and employee authors distinguished?

Verification status: Partly verified  
Reading scope: Summary read; related external material unread

- Current findings: In 2021, OmniActive supported the trial, manufactured/supplied product and matched placebo, and participated in formulation development. Priyanka Radkar, Abhijeet Morde, Deshanie Rai and Muralidhara Padigaru were employees.
- Why unverified: Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment
- Reason for missing information: Do not copy all representative support/author identities to the follow-up. Complete contractual, data and publication rights are unread.
- Required materials and conditions: OmniActive support/manufacturing/supply/development/author relationships
- Materials to obtain first: Representative funding/product/development/COI/role specifications
- Further research: Show support separately from manufacturing/development/employee relationships
- Conditions for verification: OmniActive support/manufacturing/supply/development/author relationships; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification
- Why this condition is needed: Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint
- Application exceptions: Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units
- Remaining uncertainty: External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks
- Referenced methods: Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.
- Related sources: R01

### N23 · Are follow-up trial costs, publication fees, medical writing and editorial support separated?

Verification status: Partly verified  
Reading scope: Summary read; related external material unread

- Current findings: Original follow-up wording attributes trial costs to OmniActive and publication fees/medical-writing/editorial support to Bausch + Lomb.
- Why unverified: Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment
- Reason for missing information: Do not mix publication/writing support with trial-cost funding or remove disclosed support. Outsourced analysis and data control are separately unverified.
- Required materials and conditions: Item-specific OmniActive and Bausch + Lomb roles
- Materials to obtain first: Follow-up funding, writing, editorial, publication and analysis-role disclosures
- Further research: Record trial operating costs separately from writing/publication support
- Conditions for verification: Item-specific OmniActive and Bausch + Lomb roles; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification
- Why this condition is needed: Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint
- Application exceptions: Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units
- Remaining uncertainty: External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks
- Referenced methods: Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.
- Related sources: R02

### N24 · Are follow-up employee authors and advisory-board relationships distinguished?

Verification status: Partly verified  
Reading scope: Summary read; related external material unread

- Current findings: Follow-up AM, DR and MP are recorded as OmniActive employees; RR and KB as Bausch + Lomb employees; NG, JG, JP and LP as Bausch + Lomb advisory-board members.
- Why unverified: Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment
- Reason for missing information: Do not expand initials into names absent from the original or turn advisory members into employees. Individual contributions/role details are unread.
- Required materials and conditions: Author-specific company, employment, advisory and contribution relationships
- Materials to obtain first: Follow-up author COI, affiliations and contributions
- Further research: Show employee relationships separately from advisory/individual roles
- Conditions for verification: Author-specific company, employment, advisory and contribution relationships; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification
- Why this condition is needed: Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint
- Application exceptions: Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units
- Remaining uncertainty: External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks
- Referenced methods: Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.
- Related sources: R02

### N25 · Were all analysis, data and publication controls described as verified?

Verification status: Unverified  
Reading scope: Summary read; related external material unread

- Current findings: Some support, product, development, writing, editorial and author relationships are preserved.
- Why unverified: Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment
- Reason for missing information: Do not certify unmentioned outsourced analysis, data control or other relationships as all absent or completely independent.
- Required materials and conditions: Trial-specific outsourced analysis, data rights, responsibility and publication roles
- Materials to obtain first: Complete trial-specific role/data/publication-right disclosures
- Further research: Distinguish known involvement from unverified roles
- Conditions for verification: Trial-specific outsourced analysis, data rights, responsibility and publication roles; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification
- Why this condition is needed: Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint
- Application exceptions: Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units
- Remaining uncertainty: External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks
- Referenced methods: Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.
- Related sources: R01, R02

### N26 · What actual trial scope underlies safety-collection wording?

Verification status: Partly verified  
Reading scope: Summary read; related external material unread

- Current findings: The parent safety summary says hematology, chemistry, vital signs, physical examinations and AEs were assessed, with no safety issues or serious events reported.
- Why unverified: Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment
- Reason for missing information: Follow-up-specific event tables, group denominators, collection and withdrawal scope are externally unread. Do not turn this into all events zero in both trials or safety equivalence.
- Required materials and conditions: Hematology, chemistry, vital signs, examinations, AEs and group-specific tables
- Materials to obtain first: Trial-specific group safety, collection and exposure tables
- Further research: Distinguish safety-narrative scope from trial-specific observation denominators
- Conditions for verification: Hematology, chemistry, vital signs, examinations, AEs and group-specific tables; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification
- Why this condition is needed: Supplementary condition exposing harm-collection, denominator and follow-up limits separately from efficacy
- Application exceptions: Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units
- Remaining uncertainty: External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks
- Referenced methods: Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.
- Related sources: R01, R02

### N27 · Are long-term/rare harms and soybean-oil comparator safety verified?

Verification status: Unverified  
Reading scope: Summary read; related external material unread

- Current findings: Short-term preserved results and representative soybean-oil placebo specifications are available.
- Why unverified: Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment
- Reason for missing information: Do not fill absence of long-term/rare harms, safety for every population or safety equivalence with the comparator from short-term nonreporting.
- Required materials and conditions: Long-term exposure, rare events and population/product-specific harms
- Materials to obtain first: Long-term, product/population-specific harms and exposure materials
- Further research: Separate efficacy/use comparisons from long-term safety gaps
- Conditions for verification: Long-term exposure, rare events and population/product-specific harms; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification
- Why this condition is needed: Supplementary condition exposing harm-collection, denominator and follow-up limits separately from efficacy
- Application exceptions: Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units
- Remaining uncertainty: External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks
- Referenced methods: Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.
- Related sources: R01, R02

### N28 · Is actual summary reading distinguished from unread external materials?

Verification status: Partly verified  
Reading scope: Summary read; related external material unread

- Current findings: The whole parent JSON was read; the two PubMed URLs are linked as original bibliography.
- Why unverified: Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment
- Reason for missing information: External abstracts, full texts, registrations, protocols, SAPs, links and screens were not newly read/checked. Do not treat URLs as content/reading certification.
- Required materials and conditions: Bibliography, preserved JSON, abstract, full text, registration and plan statuses
- Materials to obtain first: Original reports, registrations and plans
- Further research: Show summary reading separately from material-specific external nonreading
- Conditions for verification: Bibliography, preserved JSON, abstract, full text, registration and plan statuses; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification
- Why this condition is needed: Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint
- Application exceptions: Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units
- Remaining uncertainty: External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks
- Referenced methods: Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.
- Related sources: R01, R02

### N29 · Are original subclaim/parent history, production and user review distinguished?

Verification status: Partly verified  
Reading scope: Summary read; related external material unread

- Current findings: Preserve complete KO/EN, axes, the 2026-08-26 evidence date, empty corrections/deliberation and the selected row. Preserve original pending/eligible flags as history.
- Why unverified: Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment
- Reason for missing information: Keep content review incomplete with waiting inactive and completion marked false, new units 0 and independent confirmed totals unrecorded. The evidence date is not a new review date.
- Required materials and conditions: KO/EN, axes, dates, corrections, original selection and freeze/application
- Materials to obtain first: Original source, selected original row and production events
- Further research: Separate original verdict/corrections from condition freeze/application and user review
- Conditions for verification: KO/EN, axes, dates, corrections, original selection and freeze/application; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification
- Why this condition is needed: Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint
- Application exceptions: Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units
- Remaining uncertainty: External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks
- Referenced methods: Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.
- Related sources: R01, R02

## Evidence and sources

### R01

Radkar P, et al. A Novel Multi-Ingredient Supplement Reduces Inflammation of the Eye and Improves Production and Quality of Tears in Humans. Ophthalmol Ther. 2021;10:581-599. PMID: 34129210.

[PubMed](https://pubmed.ncbi.nlm.nih.gov/34129210/)

Materials actually read: Summary read; external abstracts, full texts, registration and plans unread  
Findings recorded in the summary: OSDI between-group P=0.0001; Schirmer between-group P<0.0001; 95% CI not reported  
Record level: 2021 representative Schirmer/OSDI context; direct artificial-tear-use values are absent from the summary.  
Independent replication: 2021 Indian representative population; separate 2024 US follow-up recruitment population. The same formulation/company lineage does not merge them into one cohort or independent-company replication.

| Material | Public availability | Access status | Actually read | Notes |
|---|---|---|---|---|
| Stored summary | Summary read | Stored summary read | Summary read | Material slot; no certification of external acquisition/reading/link checks or independent-trial counts |
| External abstract | Not read | External material unread | Not read | Material slot; no certification of external acquisition/reading/link checks or independent-trial counts |
| External full text | Not read | External material unread | Not read | Material slot; no certification of external acquisition/reading/link checks or independent-trial counts |
| Original registration | Not read | External material unread | Not read | Material slot; no certification of external acquisition/reading/link checks or independent-trial counts |
| Protocol/SAP | Not read | External material unread | Not read | Material slot; no certification of external acquisition/reading/link checks or independent-trial counts |

### R02

A novel multi-ingredient supplement significantly improves ocular symptom severity and tear production in patients with dry eye disease. Front Ophthalmol. 2024. PMID: 38984118.

[PubMed](https://pubmed.ncbi.nlm.nih.gov/38984118/)

Materials actually read: Summary read; external abstracts, full texts, registration and plans unread  
Findings recorded in the summary: Follow-up between-group P=0.562.  
Record level: Direct artificial-tear use in the 2024 four-center US follow-up, P=.562; separate from positive test/symptom results.  
Independent replication: 2021 Indian representative population; separate 2024 US follow-up recruitment population. The same formulation/company lineage does not merge them into one cohort or independent-company replication.

| Material | Public availability | Access status | Actually read | Notes |
|---|---|---|---|---|
| Stored summary | Summary read | Stored summary read | Summary read | Material slot; no certification of external acquisition/reading/link checks or independent-trial counts |
| External abstract | Not read | External material unread | Not read | Material slot; no certification of external acquisition/reading/link checks or independent-trial counts |
| External full text | Not read | External material unread | Not read | Material slot; no certification of external acquisition/reading/link checks or independent-trial counts |
| Original registration | Not read | External material unread | Not read | Material slot; no certification of external acquisition/reading/link checks or independent-trial counts |
| Protocol/SAP | Not read | External material unread | Not read | Material slot; no certification of external acquisition/reading/link checks or independent-trial counts |

## Review criteria and methods

These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score.

- M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · Preserved methodological linkages reused for production; no current methodological reassessment or external link checks, and historical quality review is not inherited
- M04 [Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · Preserved methodological linkages reused for production; no current methodological reassessment or external link checks, and historical quality review is not inherited
- M08 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · Preserved methodological linkages reused for production; no current methodological reassessment or external link checks, and historical quality review is not inherited
- M15 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · Preserved methodological linkages reused for production; no current methodological reassessment or external link checks, and historical quality review is not inherited
- M19 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · Preserved methodological linkages reused for production; no current methodological reassessment or external link checks, and historical quality review is not inherited

## What the statuses mean

- Partly verified: Some information exists in the preserved review summary; detailed original materials remain unverified. This does not certify a passed review or clinical efficacy.
- Unverified: Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety
- Review incomplete: Review of existing content incomplete
- Met: Use only within the relevant conditions after existing content review; no automatic designation in this preparation
- Not reported: Distinguish only within materials actually read; do not turn unread external materials into unreported findings
- Inaccessible: Not applied during this preparation because actual access was not tested
- Not applicable: Use with a reason for non-applicability based on an explicit question boundary
- Conflicting data: Judge after actual material comparison; review was not performed during this preparation
- Insufficient evidence for the conditions: Do not use as a clinical grade encompassing currently unread materials

## Change history

2026-10-12 · Public page/materials 1.0. Public pages and materials were created from the existing 29 items. No new clinical search, verification-status change or scoring was performed.