{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2957-s1", "verdict_number": "2957", "title": "Dry-eye combination capsule · Evidence Check for reduced artificial-tear use", "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": "The selected result concerns the 2024 four-center US dry-eye follow-up: 155 randomized, 116 analyzed. The 2021 Indian representative trial in 60 adults with mild/moderate dry eye is separate context.", "intervention": "Fixed lutein, zeaxanthin, curcumin and vitamin D3 combination capsule", "dose": "Preserved study combination: lutein 20 mg, zeaxanthin 4 mg, curcuminoids 200 mg and vitamin D3 600 IU. Trial-specific details are unread; this is not dosing guidance.", "comparator": "Follow-up placebo; the representative 2021 appearance-matched soybean-oil placebo is a separate specification.", "endpoint": "Between-group artificial-tear-use outcome; use units, direct effects, CIs and observation windows unverified. Distinguish from Schirmer/OSDI.", "duration": "Both reports concern day 56/eight weeks; exact use-observation windows and post-discontinuation follow-up are unverified.", "excluded_extensions": [ "No new research, effects, CIs, calculations, assessments, independent certification, participant totals or product/drug-use/dosing/treatment or adjunct-treatment reduction/discontinuation guidance is created" ] }, "requirements": [ { "item_id": "N01", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "What are the original wording and subclaim verdict for artificial-tear use?", "needed": "Distinguish selected-row grade/note from the parent verdict", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Distinguish selected-row grade/note from the parent verdict; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification", "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.", "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.", "proposed_research": "Present artificial-tear use separately from tear-volume/symptom verdicts", "current_reports": [ "R01", "R02" ], "existence": "Related original text, bibliography and context are in the preserved review summary; detailed external material is unverified", "acquired_read": "Summary read; related external material unread", "observation": "The original claim is reduced artificial-tear use, grade D, with the note that the follow-up between-group P=0.562. The parent is C with 50 points for tear volume/OSDI.", "condition_status": "Partly verified", "status_reason": "Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment", "missingness": "Selected-row score, status and axes are absent. Do not transfer parent C, 50 points or E+ into scores/effects for reduced artificial-tear use.", "uncertainty": "External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Selected row and original parent assessment" }, { "item_id": "N02", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "Which trial directly reported the selected use outcome?", "needed": "Trial-specific original outcomes for the 2021 representative and 2024 follow-up trials", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Trial-specific original outcomes for the 2021 representative and 2024 follow-up trials; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification", "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.", "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.", "proposed_research": "Separate different trials of the same formulation and their direct outcomes", "current_reports": [ "R01", "R02" ], "existence": "Related original text, bibliography and context are in the preserved review summary; detailed external material is unverified", "acquired_read": "Summary read; related external material unread", "observation": "Artificial-tear-use P=0.562 belongs to the 2024 four-center US follow-up. The 2021 representative trial treated Schirmer and OSDI as coprimary outcomes.", "condition_status": "Partly verified", "status_reason": "Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment", "missingness": "Do not copy positive 2021 P values or its 60-participant denominator as direct artificial-tear-use results. Use results in 2021 are unverified in the summary.", "uncertainty": "External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial-specific original use, symptom and test-result tables" }, { "item_id": "N03", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "Are the follow-up population and applicability verified?", "needed": "Follow-up dry-eye eligibility, baseline, severity and centers", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Follow-up dry-eye eligibility, baseline, severity and centers; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification", "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.", "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.", "proposed_research": "Show recruitment-population differences between 2021 and the follow-up", "current_reports": [ "R02" ], "existence": "Related original text, bibliography and context are in the preserved review summary; detailed external material is unverified", "acquired_read": "Summary read; related external material unread", "observation": "The 2024 four-center US follow-up records 155 randomized and 116 analyzed.", "condition_status": "Partly verified", "status_reason": "Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment", "missingness": "Detailed follow-up eligibility, severity, ages and baseline use are absent from the summary. Do not automatically copy 2021 Indian mild/moderate eligibility to the follow-up.", "uncertainty": "External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Follow-up eligibility, baseline characteristics and center materials" }, { "item_id": "N04", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "What are the study identity and ingredient combination?", "needed": "Fixed combination and product/exposure specifications for each trial", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Fixed combination and product/exposure specifications for each trial; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification", "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.", "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.", "proposed_research": "Distinguish the fixed finished product from individual-ingredient efficacy and other formulations", "current_reports": [ "R01", "R02" ], "existence": "Related original text, bibliography and context are in the preserved review summary; detailed external material is unverified", "acquired_read": "Summary read; related external material unread", "observation": "The preserved study capsule combines lutein 20 mg, zeaxanthin 4 mg, curcuminoids 200 mg and vitamin D3 600 IU; the follow-up is described as the same formulation.", "condition_status": "Partly verified", "status_reason": "Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment", "missingness": "This preserves study identity and is not dosing guidance. Exact products, batches and schedules in each trial are externally unread; do not isolate ingredient effects.", "uncertainty": "External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial-specific product, formulation and exposure specifications" }, { "item_id": "N05", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "Are placebo composition and trial-specific comparators distinguished?", "needed": "Active/placebo composition, appearance, exposure and blinding", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Active/placebo composition, appearance, exposure and blinding; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification", "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.", "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.", "proposed_research": "Show actual comparator conditions separately for each trial", "current_reports": [ "R01", "R02" ], "existence": "Related original text, bibliography and context are in the preserved review summary; detailed external material is unverified", "acquired_read": "Summary read; related external material unread", "observation": "The 2021 representative trial compared 30 appearance-matched soybean-oil placebo participants with 30 product participants. The follow-up was also double-blind and placebo-controlled.", "condition_status": "Partly verified", "status_reason": "Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment", "missingness": "Detailed follow-up placebo specifications, batches and blinding implementation are externally unread. Do not copy all representative-trial placebo conditions to the follow-up.", "uncertainty": "External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial-specific placebo/active specifications and blinding materials" }, { "item_id": "N06", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "What are the units and definition of artificial-tear use?", "needed": "Original definitions of frequency, volume, days, people or user proportion", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Original definitions of frequency, volume, days, people or user proportion; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification", "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.", "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.", "proposed_research": "Present use units, aggregation and person denominators", "current_reports": [ "R02" ], "existence": "Related original text, bibliography and context are in the preserved review summary; detailed external material is unverified", "acquired_read": "Summary read; related external material unread", "observation": "The preserved follow-up outcome only states artificial-tear use.", "condition_status": "Unverified", "status_reason": "Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment", "missingness": "Exact units, denominators and assessment for drop counts, frequency, product volume, days of use or user proportion are absent from the summary. Do not invent units or a reduction amount.", "uncertainty": "External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original use-outcome definition and collection tools" }, { "item_id": "N07", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "Are baseline, group-specific final values and changes available?", "needed": "Group-specific original baseline, day-56 and change values for use", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Group-specific original baseline, day-56 and change values for use; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification", "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.", "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.", "proposed_research": "Separate use quantities from values/changes in other outcomes", "current_reports": [ "R02" ], "existence": "Related original text, bibliography and context are in the preserved review summary; detailed external material is unverified", "acquired_read": "Summary read; related external material unread", "observation": "The preserved information for the selected outcome is follow-up between-group P=0.562.", "condition_status": "Unverified", "status_reason": "Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment", "missingness": "Group-specific use baseline, final values and changes are absent from the summary. Do not convert OSDI or Schirmer numbers into use quantities.", "uncertainty": "External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original group-specific baseline/final/change tables for use" }, { "item_id": "N08", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "Are between-group use effects and confidence intervals provided?", "needed": "Use differences, ratios, effect scales, CIs and tests", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Use differences, ratios, effect scales, CIs and tests; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification", "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.", "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.", "proposed_research": "Present the original test alongside missing effects/intervals", "current_reports": [ "R02" ], "existence": "Related original text, bibliography and context are in the preserved review summary; detailed external material is unverified", "acquired_read": "Summary read; related external material unread", "observation": "The follow-up between-group use result, P=0.562, was described as null and was not counted as a benefit.", "condition_status": "Partly verified", "status_reason": "Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment", "missingness": "Exact between-group effect, direction, CI and effect scale are unverified. Do not turn the P value into zero effect, equivalence or no artificial-tear use at all.", "uncertainty": "External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct comparative use effects and interval tables" }, { "item_id": "N09", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "What prespecified outcome hierarchy applies to use?", "needed": "Primary, secondary or exploratory use outcome, plans and multiplicity", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Primary, secondary or exploratory use outcome, plans and multiplicity; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification", "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.", "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.", "proposed_research": "Distinguish primary/secondary/exploratory outcomes and the use-analysis hierarchy", "current_reports": [ "R02" ], "existence": "Related original text, bibliography and context are in the preserved review summary; detailed external material is unverified", "acquired_read": "Summary read; related external material unread", "observation": "Preserved follow-up evidence lists Schirmer and OSDI outcomes and mentions artificial-tear use separately in its results.", "condition_status": "Unverified", "status_reason": "Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment", "missingness": "Prespecified use hierarchy, analysis plans and multiplicity handling are unread. Do not transfer positive coprimary outcomes into planning/success for use.", "uncertainty": "External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Follow-up protocol, SAP and outcome list" }, { "item_id": "N10", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "Are the measurement period and repeated units for use verified?", "needed": "Baseline/day-56 use observation windows, records and repeated-measure handling", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Baseline/day-56 use observation windows, records and repeated-measure handling; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification", "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.", "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.", "proposed_research": "Distinguish report assessment timing from actual use-observation windows", "current_reports": [ "R02" ], "existence": "Related original text, bibliography and context are in the preserved review summary; detailed external material is unverified", "acquired_read": "Summary read; related external material unread", "observation": "Follow-up tear-volume/symptom assessments are recorded at day 56. Use appears in the same report, but its exact observation window is absent from the summary.", "condition_status": "Partly verified", "status_reason": "Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment", "missingness": "Do not turn day 56 into invented days of use, cumulative drop counts or observation denominators. Do not add repeated measurements, eyes or people.", "uncertainty": "External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Use-record schedules, observation windows and repeated-measure handling" }, { "item_id": "N11", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "What policies governed permitted, rescue or changed artificial tears?", "needed": "Permitted adjunctive care, products, rescue, changes and recording rules in both groups", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Permitted adjunctive care, products, rescue, changes and recording rules in both groups; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification", "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.", "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.", "proposed_research": "Distinguish adjunctive-care policy/actual use from the scope of product effects", "current_reports": [ "R02" ], "existence": "Related original text, bibliography and context are in the preserved review summary; detailed external material is unverified", "acquired_read": "Summary read; related external material unread", "observation": "The summary provides a use comparison but lacks details of permission, rescue, prescribing or participant-choice policies.", "condition_status": "Unverified", "status_reason": "Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment", "missingness": "Do not attribute use differences solely to the capsule or create artificial-tear reduction, discontinuation or replacement guidance.", "uncertainty": "External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Follow-up artificial-tear/adjunctive-care rules and use tables" }, { "item_id": "N12", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "Are follow-up allocation, analysis and withdrawal denominators distinguished?", "needed": "Group-specific flow and exclusion reasons for 155 randomized and 116 analyzed", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Group-specific flow and exclusion reasons for 155 randomized and 116 analyzed; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification", "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.", "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.", "proposed_research": "Show randomized, analyzed and use-observation denominators separately", "current_reports": [ "R02" ], "existence": "Related original text, bibliography and context are in the preserved review summary; detailed external material is unverified", "acquired_read": "Summary read; related external material unread", "observation": "Follow-up evidence records 155 randomized and 116 analyzed.", "condition_status": "Partly verified", "status_reason": "Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment", "missingness": "Do not label all 116 as completers, PP participants or the use-analysis denominator. Group denominators, reasons, missingness handling and use-outcome denominators are unverified; do not calculate their difference.", "uncertainty": "External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Follow-up group-specific recruitment, analysis and use-outcome flow tables" }, { "item_id": "N13", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "Was representative-trial complete-case analysis transferred to the follow-up?", "needed": "Original/follow-up analysis populations, denominators and missingness", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Original/follow-up analysis populations, denominators and missingness; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification", "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.", "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.", "proposed_research": "Distinguish each recruitment population and original analysis method", "current_reports": [ "R01", "R02" ], "existence": "Related original text, bibliography and context are in the preserved review summary; detailed external material is unverified", "acquired_read": "Summary read; related external material unread", "observation": "In 2021, 60 were randomized (30/30) with 59 in complete-case analysis. The follow-up separately had 155 randomized and 116 analyzed.", "condition_status": "Partly verified", "status_reason": "Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment", "missingness": "Do not transfer 59/60, the complete-case approach or small eight-week-trial limitations as the exact follow-up analysis method. Do not add participants from the two trials.", "uncertainty": "External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Participant-flow, analysis and missingness tables for both trials" }, { "item_id": "N14", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "What is the scope of randomization, concealment and blinded use measurement?", "needed": "Follow-up allocation, measurement, artificial-tear records and blinding", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Follow-up allocation, measurement, artificial-tear records and blinding; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification", "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.", "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.", "proposed_research": "Distinguish design labels from actual implementation/use-measurement limitations", "current_reports": [ "R02" ], "existence": "Related original text, bibliography and context are in the preserved review summary; detailed external material is unverified", "acquired_read": "Summary read; related external material unread", "observation": "The follow-up is recorded as a multicenter double-blind placebo-controlled randomized trial.", "condition_status": "Partly verified", "status_reason": "Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment", "missingness": "Sequence generation, allocation concealment, blinding of use-record assessment and baseline balance are unread. Do not certify the design name or parent B2 as current review.", "uncertainty": "External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Follow-up allocation/concealment, use-record and assessment methods" }, { "item_id": "N15", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "Do positive OSDI/Schirmer results mean reduced artificial-tear use?", "needed": "Outcome-specific direct results for symptoms, tear volume and adjunctive-care use", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Outcome-specific direct results for symptoms, tear volume and adjunctive-care use; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification", "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.", "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.", "proposed_research": "Show distinct outcomes alongside the selected null result", "current_reports": [ "R01", "R02" ], "existence": "Related original text, bibliography and context are in the preserved review summary; detailed external material is unverified", "acquired_read": "Summary read; related external material unread", "observation": "Representative-trial OSDI between-group P=0.0001 and Schirmer P<0.0001; both follow-up measures P<0.001. Artificial-tear use is separately null, P=0.562.", "condition_status": "Partly verified", "status_reason": "Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment", "missingness": "Do not transfer positive symptom/test results into benefits for reduced adjunctive care, treatment replacement or reduced use.", "uncertainty": "External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Outcome-specific original symptom, test and use tables" }, { "item_id": "N16", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "Were representative OSDI baseline/final values converted into use quantities?", "needed": "Distinguish scales/units and within-group/between-group estimands", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Distinguish scales/units and within-group/between-group estimands; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification", "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.", "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.", "proposed_research": "Separate symptom scales from adjunctive-care use quantities", "current_reports": [ "R01" ], "existence": "Related original text, bibliography and context are in the preserved review summary; detailed external material is unverified", "acquired_read": "Summary read; related external material unread", "observation": "Representative OSDI values are product 30.10±4.88→17.09±4.85 and placebo 32.54±5.06→31.00±7.18.", "condition_status": "Partly verified", "status_reason": "Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment", "missingness": "OSDI scores differ from artificial-tear drops, frequency or days. Do not calculate values, changes or between-group differences, or copy them as reduced use.", "uncertainty": "External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Scale-specific original values, units and estimand materials" }, { "item_id": "N17", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "Are clinically important test/symptom differences and use-reduction thresholds the same?", "needed": "Use-outcome importance/interpretation criteria and direct intervals", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Use-outcome importance/interpretation criteria and direct intervals; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification", "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.", "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.", "proposed_research": "Distinguish test/symptom thresholds from direct use-outcome criteria", "current_reports": [ "R01", "R02" ], "existence": "Related original text, bibliography and context are in the preserved review summary; detailed external material is unverified", "acquired_read": "Summary read; related external material unread", "observation": "The original summary says prespecified clinically important Schirmer-mm/OSDI thresholds and tabled 95% CIs were absent.", "condition_status": "Partly verified", "status_reason": "Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment", "missingness": "Do not fill actual artificial-tear-use importance criteria or CIs with that statement. Use importance and original intervals are separately unverified.", "uncertainty": "External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Use-importance criteria, plans and effect intervals" }, { "item_id": "N18", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "Are registration identifiers and external plans distinguished?", "needed": "Representative CTRI/follow-up NCT and trial-specific plans/history", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Representative CTRI/follow-up NCT and trial-specific plans/history; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification", "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.", "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.", "proposed_research": "Distinguish trial identifiers from actual reading/prespecified plans", "current_reports": [ "R01", "R02" ], "existence": "Related original text, bibliography and context are in the preserved review summary; detailed external material is unverified", "acquired_read": "Summary read; related external material unread", "observation": "The 2021 identifier is CTRI/2021/01/030493; the follow-up identifier is NCT05481450.", "condition_status": "Partly verified", "status_reason": "Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment", "missingness": "Original registrations, dates, amendment history and use plans are unread here. Do not merge the identifiers into one registration or independence certification.", "uncertainty": "External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial-specific registrations, protocols, SAPs and amendments" }, { "item_id": "N19", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "Does the same-formulation follow-up mean the same participants or independent-company replication?", "needed": "Trial populations, centers, reports, funding and investigator links", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Trial populations, centers, reports, funding and investigator links; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification", "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.", "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.", "proposed_research": "Distinguish separate recruitment populations from funding independence/replication scope", "current_reports": [ "R01", "R02" ], "existence": "Related original text, bibliography and context are in the preserved review summary; detailed external material is unverified", "acquired_read": "Summary read; related external material unread", "observation": "The representative single-center Indian trial had 60 participants; the four-center US follow-up had 155 in a separate study population. The original narrative describes shared company development/funding and no replication by independent investigators/funders.", "condition_status": "Partly verified", "status_reason": "Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment", "missingness": "Do not merge the same formulation into one cohort or certify two reports as unique-trial/independent-replication counts. Confirmed trial/participant totals are null.", "uncertainty": "External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Report, registration, population and company-lineage links" }, { "item_id": "N20", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "Was the fixed combination extended to single ingredients or other combinations?", "needed": "Direct finished-product, ingredient and formulation comparisons", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Direct finished-product, ingredient and formulation comparisons; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification", "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.", "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.", "proposed_research": "Preserve the applicability of the fixed-combination question", "current_reports": [ "R01", "R02" ], "existence": "Related original text, bibliography and context are in the preserved review summary; detailed external material is unverified", "acquired_read": "Summary read; related external material unread", "observation": "The original advertising interpretation concerns a fixed four-ingredient combination and says it cannot be extended to lutein, curcumin or vitamin D alone, or to other combinations.", "condition_status": "Partly verified", "status_reason": "Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment", "missingness": "Do not extend the selected artificial-tear null result into ingredient-specific zero effects or equivalence with other finished products.", "uncertainty": "External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct ingredient/other-formulation comparisons" }, { "item_id": "N21", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "Does short-term use mean long-term adjunctive-care/disease-management benefit?", "needed": "Direct follow-up of post-discontinuation use, long-term symptoms and clinical outcomes", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Direct follow-up of post-discontinuation use, long-term symptoms and clinical outcomes; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification", "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.", "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.", "proposed_research": "Distinguish short-term use/tests/symptoms from gaps in long-term direct outcomes", "current_reports": [ "R01", "R02" ], "existence": "Related original text, bibliography and context are in the preserved review summary; detailed external material is unverified", "acquired_read": "Summary read; related external material unread", "observation": "Both preserved trials concern day 56/eight weeks; the selected use result is null in the follow-up report.", "condition_status": "Unverified", "status_reason": "Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment", "missingness": "Do not fill long-term reduced use, disease treatment, improved vision, treatment replacement or post-discontinuation durability with new claims.", "uncertainty": "External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Long-term post-discontinuation adjunctive-care/clinical follow-up" }, { "item_id": "N22", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "Are representative-trial funding, products, formulation development and employee authors distinguished?", "needed": "OmniActive support/manufacturing/supply/development/author relationships", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "OmniActive support/manufacturing/supply/development/author relationships; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification", "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.", "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.", "proposed_research": "Show support separately from manufacturing/development/employee relationships", "current_reports": [ "R01" ], "existence": "Related original text, bibliography and context are in the preserved review summary; detailed external material is unverified", "acquired_read": "Summary read; related external material unread", "observation": "In 2021, OmniActive supported the trial, manufactured/supplied product and matched placebo, and participated in formulation development. Priyanka Radkar, Abhijeet Morde, Deshanie Rai and Muralidhara Padigaru were employees.", "condition_status": "Partly verified", "status_reason": "Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment", "missingness": "Do not copy all representative support/author identities to the follow-up. Complete contractual, data and publication rights are unread.", "uncertainty": "External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Representative funding/product/development/COI/role specifications" }, { "item_id": "N23", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "Are follow-up trial costs, publication fees, medical writing and editorial support separated?", "needed": "Item-specific OmniActive and Bausch + Lomb roles", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Item-specific OmniActive and Bausch + Lomb roles; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification", "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.", "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.", "proposed_research": "Record trial operating costs separately from writing/publication support", "current_reports": [ "R02" ], "existence": "Related original text, bibliography and context are in the preserved review summary; detailed external material is unverified", "acquired_read": "Summary read; related external material unread", "observation": "Original follow-up wording attributes trial costs to OmniActive and publication fees/medical-writing/editorial support to Bausch + Lomb.", "condition_status": "Partly verified", "status_reason": "Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment", "missingness": "Do not mix publication/writing support with trial-cost funding or remove disclosed support. Outsourced analysis and data control are separately unverified.", "uncertainty": "External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Follow-up funding, writing, editorial, publication and analysis-role disclosures" }, { "item_id": "N24", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "Are follow-up employee authors and advisory-board relationships distinguished?", "needed": "Author-specific company, employment, advisory and contribution relationships", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Author-specific company, employment, advisory and contribution relationships; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification", "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.", "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.", "proposed_research": "Show employee relationships separately from advisory/individual roles", "current_reports": [ "R02" ], "existence": "Related original text, bibliography and context are in the preserved review summary; detailed external material is unverified", "acquired_read": "Summary read; related external material unread", "observation": "Follow-up AM, DR and MP are recorded as OmniActive employees; RR and KB as Bausch + Lomb employees; NG, JG, JP and LP as Bausch + Lomb advisory-board members.", "condition_status": "Partly verified", "status_reason": "Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment", "missingness": "Do not expand initials into names absent from the original or turn advisory members into employees. Individual contributions/role details are unread.", "uncertainty": "External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Follow-up author COI, affiliations and contributions" }, { "item_id": "N25", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "Were all analysis, data and publication controls described as verified?", "needed": "Trial-specific outsourced analysis, data rights, responsibility and publication roles", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Trial-specific outsourced analysis, data rights, responsibility and publication roles; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification", "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.", "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.", "proposed_research": "Distinguish known involvement from unverified roles", "current_reports": [ "R01", "R02" ], "existence": "Related original text, bibliography and context are in the preserved review summary; detailed external material is unverified", "acquired_read": "Summary read; related external material unread", "observation": "Some support, product, development, writing, editorial and author relationships are preserved.", "condition_status": "Unverified", "status_reason": "Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment", "missingness": "Do not certify unmentioned outsourced analysis, data control or other relationships as all absent or completely independent.", "uncertainty": "External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Complete trial-specific role/data/publication-right disclosures" }, { "item_id": "N26", "question_type": "Supplementary harm evidence", "question": "What actual trial scope underlies safety-collection wording?", "needed": "Hematology, chemistry, vital signs, examinations, AEs and group-specific tables", "role": "Supplementary", "role_reason": "Supplementary condition exposing harm-collection, denominator and follow-up limits separately from efficacy", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Hematology, chemistry, vital signs, examinations, AEs and group-specific tables; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification", "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.", "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.", "proposed_research": "Distinguish safety-narrative scope from trial-specific observation denominators", "current_reports": [ "R01", "R02" ], "existence": "Related original text, bibliography and context are in the preserved review summary; detailed external material is unverified", "acquired_read": "Summary read; related external material unread", "observation": "The parent safety summary says hematology, chemistry, vital signs, physical examinations and AEs were assessed, with no safety issues or serious events reported.", "condition_status": "Partly verified", "status_reason": "Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment", "missingness": "Follow-up-specific event tables, group denominators, collection and withdrawal scope are externally unread. Do not turn this into all events zero in both trials or safety equivalence.", "uncertainty": "External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial-specific group safety, collection and exposure tables" }, { "item_id": "N27", "question_type": "Supplementary harm evidence", "question": "Are long-term/rare harms and soybean-oil comparator safety verified?", "needed": "Long-term exposure, rare events and population/product-specific harms", "role": "Supplementary", "role_reason": "Supplementary condition exposing harm-collection, denominator and follow-up limits separately from efficacy", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Long-term exposure, rare events and population/product-specific harms; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification", "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.", "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.", "proposed_research": "Separate efficacy/use comparisons from long-term safety gaps", "current_reports": [ "R01", "R02" ], "existence": "Related original text, bibliography and context are in the preserved review summary; detailed external material is unverified", "acquired_read": "Summary read; related external material unread", "observation": "Short-term preserved results and representative soybean-oil placebo specifications are available.", "condition_status": "Unverified", "status_reason": "Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment", "missingness": "Do not fill absence of long-term/rare harms, safety for every population or safety equivalence with the comparator from short-term nonreporting.", "uncertainty": "External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Long-term, product/population-specific harms and exposure materials" }, { "item_id": "N28", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "Is actual summary reading distinguished from unread external materials?", "needed": "Bibliography, preserved JSON, abstract, full text, registration and plan statuses", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "Bibliography, preserved JSON, abstract, full text, registration and plan statuses; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification", "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.", "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.", "proposed_research": "Show summary reading separately from material-specific external nonreading", "current_reports": [ "R01", "R02" ], "existence": "Related original text, bibliography and context are in the preserved review summary; detailed external material is unverified", "acquired_read": "Summary read; related external material unread", "observation": "The whole parent JSON was read; the two PubMed URLs are linked as original bibliography.", "condition_status": "Partly verified", "status_reason": "Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment", "missingness": "External abstracts, full texts, registrations, protocols, SAPs, links and screens were not newly read/checked. Do not treat URLs as content/reading certification.", "uncertainty": "External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original reports, registrations and plans" }, { "item_id": "N29", "question_type": "Comparative efficacy: finished product and selected endpoint", "question": "Are original subclaim/parent history, production and user review distinguished?", "needed": "KO/EN, axes, dates, corrections, original selection and freeze/application", "role": "Required", "role_reason": "Production condition exposing direct original material, formulation, comparison, denominators and gaps for the selected endpoint", "application_exception": "Do not fill unverified selected material with other endpoints, formulations, trials or person/eye/measurement units", "criterion": "KO/EN, axes, dates, corrections, original selection and freeze/application; preserve original values, direct observations, scope and gaps without creating new effects, verdicts, calculations or independence certification", "basis": "Retain the production copy of existing applied conditions and methodology links; this does not mean complete review of definitions or formal certification.", "condition_origin": "New production conditions; existing content review is separately assigned, with no automated review gate passed.", "proposed_research": "Separate original verdict/corrections from condition freeze/application and user review", "current_reports": [ "R01", "R02" ], "existence": "Related original text, bibliography and context are in the preserved review summary; detailed external material is unverified", "acquired_read": "Summary read; related external material unread", "observation": "Preserve complete KO/EN, axes, the 2026-08-26 evidence date, empty corrections/deliberation and the selected row. Preserve original pending/eligible flags as history.", "condition_status": "Partly verified", "status_reason": "Display preserved-summary information, scope and direct gaps in production; this is not completed content review or a new clinical assessment", "missingness": "Keep content review incomplete with waiting inactive and completion marked false, new units 0 and independent confirmed totals unrecorded. The evidence date is not a new review date.", "uncertainty": "External abstract, full text, registration, protocol and SAP unread; no new calculation, content review or clinical checks", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original source, selected original row and production events" } ], "reports": [ { "report_id": "R01", "title": "Radkar P, et al. A Novel Multi-Ingredient Supplement Reduces Inflammation of the Eye and Improves Production and Quality of Tears in Humans. Ophthalmol Ther. 2021;10:581-599. PMID: 34129210.", "url": "https://pubmed.ncbi.nlm.nih.gov/34129210/", "report_type": "Preserved summary of trial-paper bibliography", "existence": "Present in the actual bibliography, evidence list and related text of the preserved summary", "acquired_read": "Summary read; external abstracts, full texts, registration and plans unread", "independent_replication": "Original-report linkage and company/timepoint context; no certification of independent trials or confirmed participant counts", "observed_result": "OSDI between-group P=0.0001; Schirmer between-group P<0.0001; 95% CI not reported", "result_level": "2021 representative Schirmer/OSDI context; direct artificial-tear-use values are absent from the summary.", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Summary read", "access_status": "Stored summary read", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Material slot; no certification of external acquisition/reading/link checks or independent-trial counts" }, { "material_type": "External abstract", "public_status": "Not read", "access_status": "External material unread", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "Material slot; no certification of external acquisition/reading/link checks or independent-trial counts" }, { "material_type": "External full text", "public_status": "Not read", "access_status": "External material unread", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "Material slot; no certification of external acquisition/reading/link checks or independent-trial counts" }, { "material_type": "Original registration", "public_status": "Not read", "access_status": "External material unread", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "Material slot; no certification of external acquisition/reading/link checks or independent-trial counts" }, { "material_type": "Protocol/SAP", "public_status": "Not read", "access_status": "External material unread", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "Material slot; no certification of external acquisition/reading/link checks or independent-trial counts" } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/34129210/" } ] }, { "report_id": "R02", "title": "A novel multi-ingredient supplement significantly improves ocular symptom severity and tear production in patients with dry eye disease. Front Ophthalmol. 2024. 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