{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2957-s0", "verdict_number": "2957", "title": "Lutein, zeaxanthin, curcumin, and vitamin D3 combination capsule × Improved day-56 tear volume and OSDI", "view_version": "1.0", "view_created_date": "2026-10-12", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-08-26", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "The whole stored parent-verdict summary and selected subclaim were read for production. External papers, abstracts, full texts, registry, protocol, SAP and funding disclosures were not separately read or accessed. Historical review records are not inherited as current clinical verification or a new verdict.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "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.", "intervention": "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.", "endpoint": "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.", "excluded_extensions": [ "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" ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Selected day-56 coprimary results and original values", "needed": "Original question, grade/note, parent context and absent fields", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Update research linking the original question with additional material; no new search, calculation or trial was performed here.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Retain subclaim C and its note for improved day-56 tear volume and OSDI. Parent C50 and axes are parent-assessment context.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Subclaim score/status/axes are absent and are not filled from parent values. Do not split/promote coprimary results into new subunits or grades.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Material distinguishing the selected row from the original parent assessment" }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Population with mild-to-moderate dry eye", "needed": "Recruitment, disease/baseline conditions and group characteristics", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Further research on population-specific applicability and heterogeneity; no new search, calculation or trial was performed here.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Retain the original 2021 Indian single-center population of 60 adults with mild-to-moderate dry eye, allocated 30/30.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Detailed eligibility, baseline symptoms/tears, age/comorbidity, group characteristics and correspondence with the 2024 population are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Recruitment/eligibility and group baseline material for each trial" }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Fixed four-ingredient combination capsule", "needed": "Ingredient combination, formulation/dose and product identity", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Research distinguishing combination formulation from attribution of results; no new search, calculation or trial was performed here.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Complete formulation/batch, additives/exposure, ingredient identity, actual product correspondence and adherence are unverified. No new conversion or use instructions.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Product/batch, composition and actual exposure/quality material" }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Visually matched soybean-oil placebo", "needed": "Comparator formulation, sensory matching and concurrent exposure", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Research distinguishing comparator and measurement-condition differences; no new search, calculation or trial was performed here.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The 2021 placebo was a visually matched soybean-oil capsule. The 2024 trial was also placebo-controlled, with detailed matching separately unverified.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Other ingredients/sensory features, group exposure, adherence/crossover and actual comparator conditions are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Placebo/matching and actual exposure material for each trial" }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Day-56/eight-week exposure and follow-up", "needed": "Distinguish exposure period, visits/measurement and actual completion", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Follow-up research on periods, timing and durability; no new search, calculation or trial was performed here.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Individual starts/stopping, adherence, visit windows, repeated/intermediate results and later follow-up are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Visit/exposure, stopping/observation and follow-up material" }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Randomization and blinding procedures", "needed": "Allocation/concealment and participant, measurement, assessment and analysis roles", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Research on relationships between procedures and observed results; no new search, calculation or trial was performed here.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Retain double-blind placebo-controlled randomized designs in both original evidence records. The 2021 30/30 and 2024 155 participants are separate trial denominators.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original sequence/concealment, role-specific blinding/maintenance and actual measurement/analysis procedures are unread. Design labels alone do not certify absence of bias.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Allocation, blinding/measurement and analysis records for each trial" }, { "item_id": "N07", "question_type": "Evidence condition", "question": "2021: 60 randomized and 59 complete cases", "needed": "Randomized/observed/analyzed denominators, omissions and missingness", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Further research on complete-case selection and omission assumptions; no new search, calculation or trial was performed here.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Retain 60 randomized, 30/30, and 59 in complete-case analysis. Do not calculate new missing/group-excluded counts or declare full ITT.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Group completion/omissions, reasons, endpoint-specific observations, models and missingness sensitivity are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Group flow, observation/exclusion and missingness/sensitivity material" }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Original baseline and final OSDI values", "needed": "Group OSDI timing, units, estimates and variability", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Research on baseline/final values, changes and between-group estimates; no new search, calculation or trial was performed here.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Scale/units, meaning of ±, observed/analyzed group denominators, models/adjustment and individual values are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original OSDI scale, group observation/variability and estimates" }, { "item_id": "N09", "question_type": "Evidence condition", "question": "OSDI between-group P value and precision", "needed": "Selected between-group estimate/CI, test and model", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Research distinguishing precision from clinical meaning; no new search, calculation or trial was performed here.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Retain 2021 between-group OSDI P=.0001. Do not derive new effects/CIs from group baseline/final numbers.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Exact group estimates/95% CIs, models/adjustment, prespecified important differences and test details are unverified or originally unreported.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original OSDI models, group estimates/CIs and prespecified criteria" }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Schirmer tear volume and measurement", "needed": "Tear-volume definition/units, test conditions and assessed eyes", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Research distinguishing objective tests from symptom outcomes; no new search, calculation or trial was performed here.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Schirmer is a different measure from OSDI symptoms. Retain 2021 between-group P<.0001.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Test conditions/methods, assessed eyes/repetitions, group mm values, observation denominators/models and precision are unverified. Do not transfer symptom values into tear volume.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original Schirmer measurement/eye, values/denominators and estimates" }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Coprimary outcomes, multiplicity and hierarchy", "needed": "Success rules for two prespecified endpoints and multiple comparisons/time points", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Research distinguishing prospective hierarchy from selected outcomes; no new search, calculation or trial was performed here.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original registration/protocol/SAP, success criteria, all time points/outcomes, multiplicity, hierarchy and changes are unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original plans, coprimary/multiplicity and all-results material" }, { "item_id": "N12", "question_type": "Evidence condition", "question": "CIs and prespecified importance thresholds", "needed": "Separate evidence for group CIs and clinical importance", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Research on statistical results, important differences and uncertainty; no new search, calculation or trial was performed here.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Retain historical wording that pivotal-trial tables lacked between-group 95% CIs and prespecified minimum clinically important Schirmer-mm/OSDI differences.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Exact estimates/original output, prespecified thresholds and follow-up-trial CIs/criteria are unverified. P values do not certify new CIs or clinical success.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original analyses/output, CIs and prespecified important-difference material" }, { "item_id": "N13", "question_type": "Evidence condition", "question": "2024: four centers, 155 randomized and 116 analyzed", "needed": "Follow-up-trial population, denominators, analysis and exclusions", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Research on analysis populations, omissions and follow-up results; no new search, calculation or trial was performed here.", "current_reports": [ "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Group recruitment/allocation/observation, analysis criteria, attrition/missingness and endpoint denominators/models are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Follow-up-trial group flow, analysis/missingness and baseline material" }, { "item_id": "N14", "question_type": "Evidence condition", "question": "2024 Schirmer/OSDI", "needed": "Original group results for each measure and correspondence to its trial", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Research distinguishing formulation-specific measures and populations; no new search, calculation or trial was performed here.", "current_reports": [ "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Exact values/effects/CIs, models, assessed eyes/units, baseline/final/change and hierarchy are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Follow-up endpoint measurement/analysis, values/CIs and plans" }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Artificial-tear use: P=.562, a separate outcome", "needed": "Use-outcome definition/timing, denominators and estimates", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Research distinguishing other outcomes from uncertainty; no new search, calculation or trial was performed here.", "current_reports": [ "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Use measure, counts/people, baseline/follow-up, group values/denominators, CIs/models and hierarchy are unverified. No new zero-effect or equivalence claim.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Artificial-tear use/concurrent exposure and original estimates/denominators/plans" }, { "item_id": "N16", "question_type": "Evidence condition", "question": "CTRI and NCT registration records", "needed": "Trial registration, original plans/changes and report correspondence", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Research connecting prospective plans to reports; no new search, calculation or trial was performed here.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Retain 2021 CTRI/2021/01/030493 and 2024 NCT05481450. Do not promote existence, prospective timing or correspondence into original-material reading performed here.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Registration history, protocol/SAP, recruitment/analysis timing, multiplicity and changes are unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Registration/plans, changes and report correspondence for each trial" }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Concurrent eye care and adherence", "needed": "Artificial tears/treatment, lifestyle/products and actual exposure", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Research on concurrent exposure and attribution of blend results; no new search, calculation or trial was performed here.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Retain original scope of the particular blend versus placebo. Keep follow-up artificial-tear results as a separate endpoint/concurrent-exposure context.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Other eye treatments/products, testing/environment, actual adherence/crossover/changes and artificial-tear-use records are unverified. No new management/treatment/consumption instructions.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Group concurrent exposure/management, adherence and use/change records" }, { "item_id": "N18", "question_type": "Evidence condition", "question": "2021 support, product supply and development", "needed": "Distinguish research funding, manufacturing/supply, development and other support", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Research on individual support/roles and report relationships; no new search, calculation or trial was performed here.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Retain original OmniActive study support, manufacturing/supply of product/matched placebo and participation in formulation development.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Contracts/amounts, supply/cost details, analysis/writing/publication costs and roles/disclosures are unread. Supply facts do not fill support details.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original 2021 support, product/development and analysis/writing/publication disclosures" }, { "item_id": "N19", "question_type": "Evidence condition", "question": "2021: four employee authors", "needed": "Author-specific employment/affiliation, contributions and COI", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Research on author relationships and results-reporting roles; no new search, calculation or trial was performed here.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Retain original Korean/English wording that Priyanka Radkar, Abhijeet Morde, Deshanie Rai and Muralidhara Padigaru were OmniActive-affiliated/employed.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Author contributions, employment timing/equity, other COI and analysis/writing roles are unread. Current affiliation/independence is not certified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Author-specific affiliation/employment, contribution and COI disclosures" }, { "item_id": "N20", "question_type": "Evidence condition", "question": "2024 trial funding and publication/writing support", "needed": "Institution-specific trial/publication, writing and editorial roles", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Research on individual support and report relationships; no new search, calculation or trial was performed here.", "current_reports": [ "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Retain wording that OmniActive funded the trial and Bausch + Lomb provided publication costs and medical-writing/editorial support.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Contracts, supply/analysis/data, writing contents/publication rights and other support/disclosures are unread. Do not merge 2021 roles or certify new independence.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "2024 institution-specific funding, writing/editorial, publication and role material" }, { "item_id": "N21", "question_type": "Evidence condition", "question": "2024 employees and advisory-board members", "needed": "Author/institution employment, advisory roles, contributions and COI", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Research on individual author/institution relationships and reports; no new search, calculation or trial was performed here.", "current_reports": [ "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Relationship timing, employment/contracts, contributions/equity, original COI and data/writing roles are unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original author affiliation/contribution, employment/advisory and COI material" }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Same company lineage and independence", "needed": "Distinguish two trials/reports, company development/funding and replication", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Research distinguishing shared material/company lineage from separate replication; no new search, calculation or trial was performed here.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Retain original R1/I0 context that both formulation reports share company development/funding lineage rather than replication by independent investigators/funders.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Actual trial/population/bibliographic correspondence, unique people/overlap and external independence comparison are unverified. Same-direction or multicenter findings do not certify new independence.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial/report, formulation/population, funding/development relationships and separate evidence" }, { "item_id": "N23", "question_type": "Evidence condition", "question": "People/eyes, measures and timing totals", "needed": "Report-trial-person/eye-endpoint duplication and relationships", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Research on measurement/reporting units and actual population relationships; no new search, calculation or trial was performed here.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Assessed eyes, repeated measurements/observations, person/measure correspondence and unique-person/trial totals were not externally compared.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial/person/eye, observation/measure and report relationships" }, { "item_id": "N24", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "Harm collection and nonreporting scope", "needed": "Safety populations, collection/examinations and group events/denominators", "role": "Supplementary", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Research on harm-reporting scope and later follow-up material; no new search, calculation or trial was performed here.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Retain original wording that hematology/chemistry, vital signs/physical examinations and adverse events were assessed, with safety problems/serious events unreported.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial-specific harm collection, group denominators/events and stopping/follow-up material" }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Durability, individual ingredients and other formulations", "needed": "Application outside the selected blend, population and period", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Research distinguishing combined attribution from other conditions; no new search, calculation or trial was performed here.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Individual ingredients/composition, other doses/populations, post-trial/long-term function/disease outcomes and harms are unverified. No product-selection/consumption/treatment instructions.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material by formulation/population, duration/post-trial and long-term outcome" }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Original axes, Korean/English text, dates and corrections", "needed": "Distinguish subclaim/parent values, dates/corrections and history", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Research updating original-material changes and production versions; no new search, calculation or trial was performed here.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original assessment, corrections/changes and user observations" }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Summary read; external material unread", "needed": "Material-specific actual reading, bibliography/URLs and additional-material gaps", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Scope-specific update research based on material actually acquired; no new search, calculation or trial was performed here.", "current_reports": [ "S01", "S02" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "URLs/registration or historical wording do not upgrade external acquisition/reading or content-review states; no external click/link checks were performed.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original reports/registration/plans, disclosures and user observations" } ], "reports": [ { "report_id": "S01", "title": "Radkar P et al. 2021", "url": "https://pubmed.ncbi.nlm.nih.gov/34129210/", "report_type": "Double-blind placebo-controlled randomized trial", "existence": "Stored bibliography exists; external identity unverified", "acquired_read": "Summary read; external material unread", "study_family": "RG2957-RADKAR-2021", "independent_replication": null, "observed_result": "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.", "result_level": "Outcome wording in the stored summary", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Stored file", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only stored-summary and bibliographic content was used for production. External material verification/review is not complete." }, { "material_type": "External paper", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Registration material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Protocol", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Statistical analysis plan", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Funding, product-support and COI material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/34129210/" } ] }, { "report_id": "S02", "title": "2024 four-center US follow-up trial", "url": "https://pubmed.ncbi.nlm.nih.gov/38984118/", "report_type": "Multicenter double-blind placebo-controlled randomized trial", "existence": "Stored bibliography exists; external identity unverified", "acquired_read": "Summary read; external material unread", "study_family": "RG2957-US-2024", "independent_replication": null, "observed_result": "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.", "result_level": "Outcome wording in the stored summary", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Stored file", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only stored-summary and bibliographic content was used for production. External material verification/review is not complete." }, { "material_type": "External paper", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Registration material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Protocol", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Statistical analysis plan", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Funding, product-support and COI material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/38984118/" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" } ], "status_dictionary": { "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." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "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." }, "history": [ { "date": "2026-10-12", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "Public pages and materials were prepared from the existing 27 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-12" }