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

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: 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

## Checklist items

### N01 · Selected day-56 coprimary results and original values

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

- Current findings: Retain subclaim C and its note for improved day-56 tear volume and OSDI. Parent C50 and axes are parent-assessment context.
- 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.
- 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.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- 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

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

- Current findings: Retain the original 2021 Indian single-center population of 60 adults with mild-to-moderate dry eye, allocated 30/30.
- 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.
- 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.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- 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

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

- 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.
- 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.
- 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.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- 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

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

- Current findings: The 2021 placebo was a visually matched soybean-oil capsule. The 2024 trial was also placebo-controlled, with detailed matching separately unverified.
- 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.
- 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.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- 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

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

- 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.
- 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.
- 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.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- 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

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

- 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.
- 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.
- 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.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- 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

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

- 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.
- 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.
- 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.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- 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

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

- 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.
- 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.
- 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.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- 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

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

- Current findings: Retain 2021 between-group OSDI P=.0001. Do not derive new effects/CIs from group baseline/final numbers.
- 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.
- 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.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- 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

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

- Current findings: Schirmer is a different measure from OSDI symptoms. Retain 2021 between-group P<.0001.
- 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.
- 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.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- 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

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

- 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.
- 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.
- 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.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- 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

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

- Current findings: Retain historical wording that pivotal-trial tables lacked between-group 95% CIs and prespecified minimum clinically important Schirmer-mm/OSDI differences.
- 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.
- 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.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- 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

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

- 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.
- 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.
- 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.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- 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

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

- 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.
- 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.
- 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.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- 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

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

- 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.
- 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.
- 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.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- 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

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

- 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.
- 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.
- 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.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- 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

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

- Current findings: Retain original scope of the particular blend versus placebo. Keep follow-up artificial-tear results as a separate endpoint/concurrent-exposure context.
- 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.
- 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.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- 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

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

- Current findings: Retain original OmniActive study support, manufacturing/supply of product/matched placebo and participation in formulation development.
- 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.
- 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.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- 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

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

- Current findings: Retain original Korean/English wording that Priyanka Radkar, Abhijeet Morde, Deshanie Rai and Muralidhara Padigaru were OmniActive-affiliated/employed.
- 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.
- 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.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- 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

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

- Current findings: Retain wording that OmniActive funded the trial and Bausch + Lomb provided publication costs and medical-writing/editorial support.
- 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.
- 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.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- 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

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

- 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.
- 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.
- 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.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- 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

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

- Current findings: Retain original R1/I0 context that both formulation reports share company development/funding lineage rather than replication by independent investigators/funders.
- 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.
- 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.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- 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

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

- 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.
- 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.
- 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.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- 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

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

- Current findings: Retain original wording that hematology/chemistry, vital signs/physical examinations and adverse events were assessed, with safety problems/serious events unreported.
- 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.
- 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.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- 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

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

- 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.
- 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.
- 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.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- 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

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

- 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.
- 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.
- 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.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- 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

Verification status: Partly verified  
Reading scope: 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.
- 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.
- 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.
- Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
- 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

## Evidence and sources

### S01

Radkar P et al. 2021

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

Materials actually read: Summary read; external material unread  
Findings recorded in the 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  
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.

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

Materials actually read: Summary read; external material unread  
Findings recorded in the 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  
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.

| 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. |

## 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 method HTML copies; no current method-content re-review or official tool execution
- 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 method HTML copies; no current method-content re-review or official tool execution
- 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 method HTML copies; no current method-content re-review or official tool execution
- 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 method HTML copies; no current method-content re-review or official tool execution
- 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 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/materials 1.0. Public pages and materials were prepared from the existing 27 items. No new clinical search, verification-status change or scoring was performed.