{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2987-s1", "verdict_number": "2987", "title": "Oral lactoferrin × gaps in direct evidence for chronic dry-eye treatment", "view_version": "1.0", "view_created_date": "2026-10-16", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-09-07", "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 question concerns patients with general chronic dry eye. The preserved contextual trial enrolled small-incision cataract surgery patients without pre-existing dry eye, a different population; direct data by chronic-dry-eye diagnosis, duration, severity and subtype are unverified.", "intervention": "Formulation, actual exposure, adherence and direct effects of oral lactoferrin for the selected question are unverified. The preserved postoperative trial added oral lactoferrin 350 mg/day to routine care; this is not transferred to chronic-dry-eye exposure.", "dose": "350 mg/day for 60 days from the day after surgery identifies existing research exposure in a different population. No appropriate amount, duration or cumulative exposure for general chronic dry eye is set, and no dosing, product, postoperative-care or dry-eye treatment instructions are created.", "comparator": "Direct comparisons of adding to or replacing standard care for general chronic dry eye are unverified. These are distinguished from the original postoperative comparison of routine care alone versus added lactoferrin, without placebo, with natural recovery and shared drops.", "endpoint": "Direct symptoms, tests, quality of life, function and patient-important outcomes in general chronic dry eye are unverified. Day-60 postoperative tBUT 13.9/7.86 seconds, Schirmer 30.9/15.86 mm and at least mild OSDI symptoms 26.6/42.8% in a different population are preserved separately as original context and are not transferred to chronic-dry-eye effects.", "duration": "Direct duration, persistence after discontinuation, recurrence and long-term follow-up in the selected general chronic-dry-eye population are unverified. Original postoperative day 60, actual observation times, exposure and harm follow-up are distinguished.", "excluded_extensions": [ "Transferring tBUT/Schirmer test differences to the same efficacy for OSDI, daily function, visual recovery or all eye health", "Extending day-60 results in a selected population without pre-existing dry eye to all chronic dry eye, other surgery or long-term efficacy", "Calculating new differences, effects, CIs, noncompletion rates or event counts from the original 64 randomized/58 completers, 32 per group/28 and 30 analyzed/6 noncompleters, test values or symptom percentages", "Adding people, operated eyes, both eyes, tests, repeated measurements, times or two sheets as independent trials or participants", "Using nonreporting of selected symptoms, no financial/competing interests reported, parent Good safety/I2 or historical verification to certify overall/long-term safety, independence or completed content review now", "Filling absent subclaim score/status/axes from parent C54 or generating dosing, product, surgery, postoperative-care or dry-eye treatment instructions" ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "How is the general chronic-dry-eye question distinguished from the postoperative question?", "needed": "Selected chronic-dry-eye question, parent context and postoperative subclaim", "role": "Required", "role_reason": "This condition connects Selected chronic-dry-eye question, parent context and postoperative subclaim with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.", "criterion": "Material for Selected chronic-dry-eye question, parent context and postoperative subclaim must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Direct trials and clinical independence of the general chronic-dry-eye question have not been newly verified. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The selected existing question is “Treatment of chronic dry-eye disease in general.” “Improved tear-film tests 60 days after cataract surgery” and the parent's postoperative results are preserved as a different scope; no new questions or splits are created.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Direct trials and clinical independence of the general chronic-dry-eye question have not been newly verified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct trials and clinical independence of the general chronic-dry-eye question have not been newly verified." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "What are the selected subclaim verdict and unrecorded values?", "needed": "Subclaim grade/note; absent score, status and axes", "role": "Required", "role_reason": "This condition connects Subclaim grade/note; absent score, status and axes with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.", "criterion": "Material for Subclaim grade/note; absent score, status and axes must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Absent subclaim score, status and axes are not filled from parent values. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The selected subclaim grade is ?, with note “Patients with pre-existing dry eye were excluded.” Subclaim score, status and axes are absent from the original; parent C54 concerns the postoperative context.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Absent subclaim score, status and axes are not filled from parent values.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Absent subclaim score, status and axes are not filled from parent values." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Are general chronic-dry-eye patients the same as the actual surgical population?", "needed": "Chronic-dry-eye diagnosis, duration, severity and trial eligibility", "role": "Required", "role_reason": "This condition connects Chronic-dry-eye diagnosis, duration, severity and trial eligibility with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.", "criterion": "Material for Chronic-dry-eye diagnosis, duration, severity and trial eligibility must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Direct data by chronic-dry-eye diagnosis, duration, severity and subtype are unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The selected question concerns general chronic dry eye, but the original trial enrolled cataract patients without pre-existing dry eye and excluded those with existing dry eye. Its results are not transferred to direct findings in general chronic dry eye.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Direct data by chronic-dry-eye diagnosis, duration, severity and subtype are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct data by chronic-dry-eye diagnosis, duration, severity and subtype are unverified." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "What is recorded about the original surgical population at baseline?", "needed": "Surgery type, baseline tear-film and symptom status, and eligibility", "role": "Supplementary", "role_reason": "This condition connects Surgery type, baseline tear-film and symptom status, and eligibility with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.", "criterion": "Material for Surgery type, baseline tear-film and symptom status, and eligibility must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Baseline characteristics, exclusions, surgical method and test details are unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The original material records small-incision cataract surgery patients without pre-existing dry eye. Exact age, illnesses, surgery and baseline test details are absent from the stored summary.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Baseline characteristics, exclusions, surgical method and test details are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Baseline characteristics, exclusions, surgical method and test details are unverified." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Which population do the oral formulation and exposure describe?", "needed": "Postoperative research exposure and the chronic-dry-eye exposure gap", "role": "Required", "role_reason": "This condition connects Postoperative research exposure and the chronic-dry-eye exposure gap with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.", "criterion": "Material for Postoperative research exposure and the chronic-dry-eye exposure gap must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Manufacturing, source material, product specifications and direct exposure data in general chronic dry eye are unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "Oral lactoferrin 350 mg/day is research exposure from the postoperative trial. It does not fill gaps in formulation, exposure or treatment duration for general chronic dry eye.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Manufacturing, source material, product specifications and direct exposure data in general chronic dry eye are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Manufacturing, source material, product specifications and direct exposure data in general chronic dry eye are unverified." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Are postoperative timing and chronic-dry-eye follow-up distinguished?", "needed": "Use for 60 days from the day after surgery versus long-term follow-up", "role": "Required", "role_reason": "This condition connects Use for 60 days from the day after surgery versus long-term follow-up with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.", "criterion": "Material for Use for 60 days from the day after surgery versus long-term follow-up must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Actual adherence, post-treatment follow-up and time-specific results in chronic dry eye are unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "Existing product information records use for 60 days from the day after small-incision surgery. This is not read as direct treatment duration, persistence after discontinuation or long-term follow-up in general chronic dry eye.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Actual adherence, post-treatment follow-up and time-specific results in chronic dry eye are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual adherence, post-treatment follow-up and time-specific results in chronic dry eye are unverified." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Is the postoperative control the same as a chronic-dry-eye standard-care comparison?", "needed": "Routine postoperative care, add-on intervention and chronic-dry-eye comparators", "role": "Required", "role_reason": "This condition connects Routine postoperative care, add-on intervention and chronic-dry-eye comparators with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.", "criterion": "Material for Routine postoperative care, add-on intervention and chronic-dry-eye comparators must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Details and adherence of postoperative drops, and direct comparisons with specific chronic-dry-eye standard treatments, are unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The original trial compared routine postoperative care alone with lactoferrin added to that care, without placebo. The stored summary contains no direct comparison of adding to or replacing standard care for general chronic dry eye.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Details and adherence of postoperative drops, and direct comparisons with specific chronic-dry-eye standard treatments, are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Details and adherence of postoperative drops, and direct comparisons with specific chronic-dry-eye standard treatments, are unverified." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Are natural postoperative recovery and concurrent care distinguished?", "needed": "Natural recovery, shared drops and between-group differences", "role": "Required", "role_reason": "This condition connects Natural recovery, shared drops and between-group differences with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.", "criterion": "Material for Natural recovery, shared drops and between-group differences must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Baseline and time-specific recovery, shared treatment types, changes and adherence are unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The historical counterview records natural postoperative recovery, routine drops and no masking. Specific treatments and between-group differences are absent from the stored summary.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Baseline and time-specific recovery, shared treatment types, changes and adherence are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Baseline and time-specific recovery, shared treatment types, changes and adherence are unverified." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Which population does the day-60 tBUT value describe?", "needed": "Tear-breakup-time units, groups and timing", "role": "Supplementary", "role_reason": "This condition connects Tear-breakup-time units, groups and timing with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.", "criterion": "Material for Tear-breakup-time units, groups and timing must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Baseline values, repeated measurements, variance, effect CIs and endpoint-specific denominators are unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "Postoperative day-60 tBUT was 13.9 seconds with lactoferrin and 7.86 seconds with control. These are neither direct effects in general chronic dry eye nor changes from baseline.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Baseline values, repeated measurements, variance, effect CIs and endpoint-specific denominators are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Baseline values, repeated measurements, variance, effect CIs and endpoint-specific denominators are unverified." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "How is Schirmer testing distinguished from tBUT?", "needed": "Schirmer test 1, mm units, groups and timing", "role": "Supplementary", "role_reason": "This condition connects Schirmer test 1, mm units, groups and timing with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.", "criterion": "Material for Schirmer test 1, mm units, groups and timing must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Test conduct, anesthesia, baseline and variability, CIs and denominators are unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "Original postoperative day-60 Schirmer test 1 values were 30.9 mm with lactoferrin versus 15.86 mm with control. This differs from tBUT in seconds and is not a direct effect in general chronic dry eye.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Test conduct, anesthesia, baseline and variability, CIs and denominators are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Test conduct, anesthesia, baseline and variability, CIs and denominators are unverified." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "What does the proportion with at least mild OSDI symptoms answer?", "needed": "Symptom scale, threshold, timing and original proportions", "role": "Supplementary", "role_reason": "This condition connects Symptom scale, threshold, timing and original proportions with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.", "criterion": "Material for Symptom scale, threshold, timing and original proportions must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: The mild-symptom score threshold, event counts, exact denominators, CIs and assessment procedure are unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "Original postoperative day-60 proportions with at least mild OSDI symptoms were 26.6% with lactoferrin and 42.8% with control. These are not transferred to direct symptom results in general chronic dry eye and are distinguished from OSDI total-score changes.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "The mild-symptom score threshold, event counts, exact denominators, CIs and assessment procedure are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The mild-symptom score threshold, event counts, exact denominators, CIs and assessment procedure are unverified." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Has direct symptom improvement in general chronic dry eye been verified?", "needed": "Symptom scales and effects of interest in general chronic dry eye", "role": "Required", "role_reason": "This condition connects Symptom scales and effects of interest in general chronic dry eye with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.", "criterion": "Material for Symptom scales and effects of interest in general chronic dry eye must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Direct symptom effects, CIs, denominators and duration in general chronic dry eye are unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The preserved report concerns postoperative patients without pre-existing dry eye. The stored summary contains no direct comparative values for discomfort, pain, daily function or symptom scales in general chronic disease.", "condition_status": "Unverified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Direct symptom effects, CIs, denominators and duration in general chronic dry eye are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct symptom effects, CIs, denominators and duration in general chronic dry eye are unverified." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Have quality-of-life and functional results in general chronic dry eye been verified?", "needed": "Disease-related quality of life, function and clinical importance", "role": "Required", "role_reason": "This condition connects Disease-related quality of life, function and clinical importance with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.", "criterion": "Material for Disease-related quality of life, function and clinical importance must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Outcome definitions, effects of interest, importance and CIs in chronic dry eye are unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "Preserved original endpoints are tBUT, Schirmer test 1 and OSDI. Direct quality-of-life, daily-function, visual and other results in general chronic dry eye are not separately provided.", "condition_status": "Unverified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Outcome definitions, effects of interest, importance and CIs in chronic dry eye are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Outcome definitions, effects of interest, importance and CIs in chronic dry eye are unverified." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Do postoperative test differences answer general chronic-dry-eye treatment?", "needed": "Postoperative tests and symptoms versus patient-important chronic-dry-eye outcomes", "role": "Required", "role_reason": "This condition connects Postoperative tests and symptoms versus patient-important chronic-dry-eye outcomes with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.", "criterion": "Material for Postoperative tests and symptoms versus patient-important chronic-dry-eye outcomes must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Direct relationships among tests, symptoms and clinical outcomes in chronic dry eye are unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The parent records concordant objective tests, within a narrow postoperative population, 60 days and an open-label completer analysis. This is not extended to direct proof of general chronic-dry-eye treatment.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Direct relationships among tests, symptoms and clinical outcomes in chronic dry eye are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct relationships among tests, symptoms and clinical outcomes in chronic dry eye are unverified." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "What has been verified about the original randomized parallel design?", "needed": "Center, simple randomization, allocation concealment and parallel comparison", "role": "Supplementary", "role_reason": "This condition connects Center, simple randomization, allocation concealment and parallel comparison with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.", "criterion": "Material for Center, simple randomization, allocation concealment and parallel comparison must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Sequence generation, allocation concealment, baseline balance and allocation responsibility are unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The original design is a single-center nonblinded simple-randomized parallel trial; the research description records 32 participants allocated per group. Actual allocation methods and concealment have not been externally verified.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Sequence generation, allocation concealment, baseline balance and allocation responsibility are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Sequence generation, allocation concealment, baseline balance and allocation responsibility are unverified." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Have measurement procedures in the unmasked, no-placebo trial been verified?", "needed": "Participant and assessor masking, tests and symptom collection", "role": "Supplementary", "role_reason": "This condition connects Participant and assessor masking, tests and symptom collection with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.", "criterion": "Material for Participant and assessor masking, tests and symptom collection must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Assessor procedures, test standardization, OSDI collection and masking details are unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The stored summary records no placebo or masking. It does not provide the individual procedures for objective tests and symptom assessment.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Assessor procedures, test standardization, OSDI collection and masking details are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Assessor procedures, test standardization, OSDI collection and masking details are unverified." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "What are the original randomized, completed and analyzed denominators?", "needed": "64 randomized, 58 analyzed, group allocation and noncompletion", "role": "Supplementary", "role_reason": "This condition connects 64 randomized, 58 analyzed, group allocation and noncompletion with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.", "criterion": "Material for 64 randomized, 58 analyzed, group allocation and noncompletion must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Endpoint-specific valid denominators, missingness, group-specific dropout reasons and detailed original tables are unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "Original 64 randomized, 32 allocated per group, 58 completers analyzed and 6 not completing follow-up are preserved. The research description records 28 and 30 analyzed. These are not denominators for general chronic dry eye.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Endpoint-specific valid denominators, missingness, group-specific dropout reasons and detailed original tables are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Endpoint-specific valid denominators, missingness, group-specific dropout reasons and detailed original tables are unverified." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Have people, eyes and repeated measurements been distinguished?", "needed": "Participants, one or both eyes, and visit-specific observations", "role": "Required", "role_reason": "This condition connects Participants, one or both eyes, and visit-specific observations with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.", "criterion": "Material for Participants, one or both eyes, and visit-specific observations must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Operated/tested-eye selection, correlation between eyes, repeated-measure handling and denominators are unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The original participant count describes people. Whether one or both eyes were tested and the eye-specific or visit-specific analysis units are not verified in the stored summary.", "condition_status": "Unverified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Operated/tested-eye selection, correlation between eyes, repeated-measure handling and denominators are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Operated/tested-eye selection, correlation between eyes, repeated-measure handling and denominators are unverified." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Have completer analysis and missing-data handling been verified?", "needed": "Effects of interest in completers versus randomized participants and missing data", "role": "Required", "role_reason": "This condition connects Effects of interest in completers versus randomized participants and missing data with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.", "criterion": "Material for Effects of interest in completers versus randomized participants and missing data must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Analysis-population definitions, reasons for and handling of missing data, sensitivity analyses and adjusted models are unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The original material records the limitation of analyzing only 58 completers. ITT, PP, adjustment, imputation and sensitivity analyses are not newly inferred.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Analysis-population definitions, reasons for and handling of missing data, sensitivity analyses and adjusted models are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Analysis-population definitions, reasons for and handling of missing data, sensitivity analyses and adjusted models are unverified." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Are final values distinguished from baseline changes and adjusted effects?", "needed": "Day-60 final values, baseline values and effects of interest", "role": "Required", "role_reason": "This condition connects Day-60 final values, baseline values and effects of interest with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.", "criterion": "Material for Day-60 final values, baseline values and effects of interest must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Baseline, changes, variance, adjusted effects and CIs are unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "tBUT and Schirmer are provided as day-60 group values. Changes from baseline and baseline-adjusted between-group effects are not separately provided in the stored summary.", "condition_status": "Unverified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Baseline, changes, variance, adjusted effects and CIs are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Baseline, changes, variance, adjusted effects and CIs are unverified." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Have precision and clinical importance of the original results been verified?", "needed": "Variance, P values, CIs and importance of test and symptom results", "role": "Required", "role_reason": "This condition connects Variance, P values, CIs and importance of test and symptom results with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.", "criterion": "Material for Variance, P values, CIs and importance of test and symptom results must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: CIs, variance, denominators and clinical importance for test and OSDI effects are unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The original summary describes large differences but gives no result-specific P values, CIs, variance or clinical-importance thresholds. The parent's unrecorded precision is preserved.", "condition_status": "Unverified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "CIs, variance, denominators and clinical importance for test and OSDI effects are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "CIs, variance, denominators and clinical importance for test and OSDI effects are unverified." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Has the prespecified hierarchy of test and symptom outcomes been verified?", "needed": "Primary, secondary and coprimary outcomes, visits and multiplicity", "role": "Required", "role_reason": "This condition connects Primary, secondary and coprimary outcomes, visits and multiplicity with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.", "criterion": "Material for Primary, secondary and coprimary outcomes, visits and multiplicity must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Prespecified outcome hierarchy, visit analyses, multiplicity and selective-reporting plans are unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "Original endpoint fields list tBUT, Schirmer and OSDI together. Field names alone are not treated as verification of prespecified coprimary outcomes or hierarchy.", "condition_status": "Unverified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Prespecified outcome hierarchy, visit analyses, multiplicity and selective-reporting plans are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Prespecified outcome hierarchy, visit analyses, multiplicity and selective-reporting plans are unverified." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Have registration, protocol and analysis plans actually been read?", "needed": "Registration identifiers, prior plans and current reading scope", "role": "Required", "role_reason": "This condition connects Registration identifiers, prior plans and current reading scope with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.", "criterion": "Material for Registration identifiers, prior plans and current reading scope must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Actual registration existence, identifiers and plan contents are unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "Current evidence and citation lists contain no registration identifier, and the evidence record lacks the corresponding registration-number field. External registration, protocols and SAPs were neither searched nor read.", "condition_status": "Unverified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Actual registration existence, identifiers and plan contents are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual registration existence, identifiers and plan contents are unverified." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "What is the scope of the original funding and competing-interest statement?", "needed": "Original disclosures, funding, product provision and support roles", "role": "Supplementary", "role_reason": "This condition connects Original disclosures, funding, product provision and support roles with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.", "criterion": "Material for Original disclosures, funding, product provision and support roles must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Original disclosures, funding sources, product provision, employment, and design, analysis and publication roles remain unverified in detail. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The funding record says “No financial or competing interests reported.” External original disclosures, in-kind support and manufacturer involvement were not additionally checked during this production.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Original disclosures, funding sources, product provision, employment, and design, analysis and publication roles remain unverified in detail.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original disclosures, funding sources, product provision, employment, and design, analysis and publication roles remain unverified in detail." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "How are the same report, trial, people and tests distinguished?", "needed": "Devendra and Singh bibliography, study family and observation relationships", "role": "Required", "role_reason": "This condition connects Devendra and Singh bibliography, study family and observation relationships with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.", "criterion": "Material for Devendra and Singh bibliography, study family and observation relationships must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Related reports, populations and unique-trial/participant totals have not been newly established. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "One existing evidence entry and one citation are linked as one report. tBUT, Schirmer, OSDI, repeated visits, eye-level observations and the two subclaim questions are not counted as new independent trials.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Related reports, populations and unique-trial/participant totals have not been newly established.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Related reports, populations and unique-trial/participant totals have not been newly established." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Has direct independent replication in general chronic dry eye been verified?", "needed": "Direct reports, trial relationships and independence in the selected population", "role": "Required", "role_reason": "This condition connects Direct reports, trial relationships and independence in the selected population with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.", "criterion": "Material for Direct reports, trial relationships and independence in the selected population must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Identities and overlap of direct replication or independent reports in general chronic dry eye are unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "Parent R1/I2 and the historical description of an independent randomized trial concern the postoperative context. The current stored summary contains no material establishing direct independent replication for the general chronic-dry-eye question.", "condition_status": "Unverified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Identities and overlap of direct replication or independent reports in general chronic dry eye are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Identities and overlap of direct replication or independent reports in general chronic dry eye are unverified." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Can results be transferred to combinations, other formulations or subtypes?", "needed": "Boundaries between single lactoferrin and other products or populations", "role": "Supplementary", "role_reason": "This condition connects Boundaries between single lactoferrin and other products or populations with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.", "criterion": "Material for Boundaries between single lactoferrin and other products or populations must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Direct comparisons for combinations, other formulations and subtypes are unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "Existing product information records that no other vitamin/omega-3 combination efficacy was tested. Direct effects of other ingredients, formulations or chronic-dry-eye subtypes are not inferred.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Direct comparisons for combinations, other formulations and subtypes are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct comparisons for combinations, other formulations and subtypes are unverified." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Are persistence and post-treatment follow-up in general chronic dry eye available?", "needed": "Time-specific symptoms, tests and post-discontinuation outcomes", "role": "Required", "role_reason": "This condition connects Time-specific symptoms, tests and post-discontinuation outcomes with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.", "criterion": "Material for Time-specific symptoms, tests and post-discontinuation outcomes must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Persistence, recurrence, long-term effects, CIs and denominators in general chronic dry eye are unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "Day-60 postoperative material does not provide repeated-use, post-discontinuation persistence or long-term follow-up results in general chronic dry eye.", "condition_status": "Unverified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Persistence, recurrence, long-term effects, CIs and denominators in general chronic dry eye are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Persistence, recurrence, long-term effects, CIs and denominators in general chronic dry eye are unverified." }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Are acquisition, actual reading and source links distinguished?", "needed": "Stored summary versus external abstracts, full text and needed material", "role": "Required", "role_reason": "This condition connects Stored summary versus external abstracts, full text and needed material with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.", "criterion": "Material for Stored summary versus external abstracts, full text and needed material must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Current content verification of the external paper's methods and result tables remains incomplete. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The complete stored summary for verdict 2987 was read and copied for production. The original PubMed URL and PMCID bibliography are preserved, while external abstracts, full text, registration and other original material remain unread and were not accessed.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Current content verification of the external paper's methods and result tables remains incomplete.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Current content verification of the external paper's methods and result tables remains incomplete." }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Are original Korean/English values, dates and historical checks distinguished?", "needed": "Original bilingual text, evidence date, corrections, axes and empty values", "role": "Required", "role_reason": "This condition connects Original bilingual text, evidence date, corrections, axes and empty values with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.", "criterion": "Material for Original bilingual text, evidence date, corrections, axes and empty values must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Detailed translation and correction comparison against external originals were not performed this time. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "Original Korean/English text, 2026-09-07, empty correction and deliberation records, B/S/R1/I2/E+/B2, unrecorded precision, four false flags, empty override reasons and parent C54 are preserved. Historical PMC, bibliographic and scoring checks are not a passed clinical review now.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Detailed translation and correction comparison against external originals were not performed this time.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Detailed translation and correction comparison against external originals were not performed this time." }, { "item_id": "N31", "question_type": "Evidence condition", "question": "Have adverse-event collection and definitions been verified?", "needed": "Symptom collection, severity and active/passive assessment", "role": "Supplementary", "role_reason": "This condition connects Symptom collection, severity and active/passive assessment with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.", "criterion": "Material for Symptom collection, severity and active/passive assessment must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Collection methods, definitions, severity and other harm outcomes are unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The original material records no participants complaining of diarrhea, appetite loss, rash or constipation, but the stored summary lacks collection methods, definitions, time-specific assessment and the full range of harms.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Collection methods, definitions, severity and other harm outcomes are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Collection methods, definitions, severity and other harm outcomes are unverified." }, { "item_id": "N32", "question_type": "Evidence condition", "question": "What denominators and comparisons underlie no reports of four symptoms?", "needed": "58 analyzed, group-specific harm denominators and reporting scope", "role": "Supplementary", "role_reason": "This condition connects 58 analyzed, group-specific harm denominators and reporting scope with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.", "criterion": "Material for 58 analyzed, group-specific harm denominators and reporting scope must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Group-specific/all-randomized harm denominators, collection completeness and CIs are unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The original safety description records no reports of four symptoms among 58 analyzed. Group-specific harm denominators and collection across all randomized participants are not separately provided.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Group-specific/all-randomized harm denominators, collection completeness and CIs are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Group-specific/all-randomized harm denominators, collection completeness and CIs are unverified." }, { "item_id": "N33", "question_type": "Evidence condition", "question": "Have harm timing and long-term or delayed observation been verified?", "needed": "Exposure/follow-up timing and symptom observation periods", "role": "Supplementary", "role_reason": "This condition connects Exposure/follow-up timing and symptom observation periods with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.", "criterion": "Material for Exposure/follow-up timing and symptom observation periods must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Symptom onset/end and delayed or long-term harm follow-up are unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "Original 60-day use/assessment and the statement on four symptoms during the study are preserved. Post-treatment observations, symptom timing and delayed-harm data are absent from the stored summary.", "condition_status": "Unverified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Symptom onset/end and delayed or long-term harm follow-up are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Symptom onset/end and delayed or long-term harm follow-up are unverified." }, { "item_id": "N34", "question_type": "Evidence condition", "question": "Have alternative causes involving surgery, drops and baseline status been distinguished?", "needed": "Natural postoperative course, concurrent care and harm relationships", "role": "Supplementary", "role_reason": "This condition connects Natural postoperative course, concurrent care and harm relationships with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.", "criterion": "Material for Natural postoperative course, concurrent care and harm relationships must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Event-specific timing, concurrent medicines, baseline status and relatedness assessment are unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The original context includes natural postoperative recovery and routine drops. The stored summary lacks material distinguishing symptoms/harms related to surgery, shared care or lactoferrin.", "condition_status": "Unverified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Event-specific timing, concurrent medicines, baseline status and relatedness assessment are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Event-specific timing, concurrent medicines, baseline status and relatedness assessment are unverified." }, { "item_id": "N35", "question_type": "Evidence condition", "question": "Have effects of noncompletion on harms and efficacy been verified?", "needed": "Reasons for 6 noncompleters, group missingness and data handling", "role": "Supplementary", "role_reason": "This condition connects Reasons for 6 noncompleters, group missingness and data handling with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.", "criterion": "Material for Reasons for 6 noncompleters, group missingness and data handling must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Group-specific dropout reasons, discontinuation, missingness and event handling are unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "Original 6 not completing follow-up and 58 completers analyzed are preserved. Whether noncompletion involved harms, efficacy or other reasons, and event collection among noncompleters, are not provided.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Group-specific dropout reasons, discontinuation, missingness and event handling are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Group-specific dropout reasons, discontinuation, missingness and event handling are unverified." }, { "item_id": "N36", "question_type": "Evidence condition", "question": "Have separate harm data in general chronic dry eye been verified?", "needed": "Direct safety in the selected chronic-dry-eye population and formulation", "role": "Supplementary", "role_reason": "This condition connects Direct safety in the selected chronic-dry-eye population and formulation with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.", "criterion": "Material for Direct safety in the selected chronic-dry-eye population and formulation must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Identities of separate harm studies and reports in general chronic dry eye are unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The currently preserved postoperative report alone does not establish direct harms or safety in general chronic-dry-eye patients. Separate original harm material was not searched this time.", "condition_status": "Unverified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Identities of separate harm studies and reports in general chronic dry eye are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Identities of separate harm studies and reports in general chronic dry eye are unverified." }, { "item_id": "N37", "question_type": "Evidence condition", "question": "What is the scope for allergy, comorbidities, medicines and long-term use?", "needed": "Originally limited populations and actual collection/follow-up", "role": "Supplementary", "role_reason": "This condition connects Originally limited populations and actual collection/follow-up with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.", "criterion": "Material for Originally limited populations and actual collection/follow-up must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Eligibility, exposure, medicines, long-term events and denominators in those populations are unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The original safety description states that long-term safety cannot be judged in people with milk-protein allergy, other illnesses or medicines. Events/effects in those populations are not described as verified by this trial.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Eligibility, exposure, medicines, long-term events and denominators in those populations are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Eligibility, exposure, medicines, long-term events and denominators in those populations are unverified." }, { "item_id": "N38", "question_type": "Evidence condition", "question": "Is no reporting of selected symptoms distinguished from overall safety?", "needed": "Selected symptoms, parent safety history and selected-population safety", "role": "Supplementary", "role_reason": "This condition connects Selected symptoms, parent safety history and selected-population safety with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.", "criterion": "Material for Selected symptoms, parent safety history and selected-population safety must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Direct comparative harms, causality, precision and long-term event data are unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "Parent “Good” safety and no reports of four symptoms concern the original postoperative context. Comparative safety, absence of all harms and long-term causal safety for general chronic-dry-eye treatment have not been directly verified.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Direct comparative harms, causality, precision and long-term event data are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct comparative harms, causality, precision and long-term event data are unverified." }, { "item_id": "N39", "question_type": "Evidence condition", "question": "How will later evidence and condition versions be linked?", "needed": "New original material, before/after values, actual reading and condition changes", "role": "Supplementary", "role_reason": "This condition connects New original material, before/after values, actual reading and condition changes with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.", "criterion": "Material for New original material, before/after values, actual reading and condition changes must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: No later original material or actual reading/change event is currently recorded. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The production record linking the complete preserved original and application conditions is retained. If direct general chronic-dry-eye material is added, population, exposure, endpoints, denominators, duration, actual reading and original values will be recorded separately.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "No later original material or actual reading/change event is currently recorded.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "No later original material or actual reading/change event is currently recorded." }, { "item_id": "N40", "question_type": "Evidence condition", "question": "Are earlier production and current content verification distinguished?", "needed": "Original selection history, production, content and boundary review", "role": "Supplementary", "role_reason": "This condition connects Original selection history, production, content and boundary review with the selected question, actual surgical population, oral intervention, routine-care control, tests and symptoms, time points, people and eyes, denominators and harms.", "application_exception": "Preserve original numbers while distinguishing the selected population without pre-existing dry eye from general chronic dry eye, oral add-on treatment from routine care/natural recovery, tBUT/Schirmer/OSDI, people/eyes/repeated tests, times, denominators, exposure, support, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, dosing, product, eye-health, surgery, postoperative-care or dry-eye treatment instructions are created.", "criterion": "Material for Original selection history, production, content and boundary review must be linked to the selected subclaim, parent context, original report, test units, times, comparator and denominators, distinguishing unread external material.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Later content-review decisions and the final count of clinical independence remain undecided. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "Original candidate-selection, production-eligibility and independence markings are retained as history. Review of existing content and applicability boundaries remains incomplete; no new clinical independence or verdict is established.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Later content-review decisions and the final count of clinical independence remain undecided.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Later content-review decisions and the final count of clinical independence remain undecided." } ], "reports": [ { "report_id": "R01", "title": "Devendra J, Singh S. Effect of Oral Lactoferrin on Cataract Surgery Induced Dry Eye: A Randomised Controlled Trial. J Clin Diagn Res. 2015;9(10):NC06-NC09. PMID: 26557550. PMCID: PMC4625269. DOI: 10.7860/JCDR/2015/15797.6670.", "url": "https://pubmed.ncbi.nlm.nih.gov/26557550/", "report_type": "Context from a single-center nonblinded simple-randomized parallel trial in a different population; direct general chronic-dry-eye trials are unverified", "existence": "The stored evidence/citation lists contain the original report bibliography. External public availability and access status are unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registrations and plans unread", "study_family": "SF01", "independent_replication": "Review of existing content remains incomplete. The same report, population, conditions, eyes and repeated measurements are not counted as new independent trials.", "observed_result": "Day-60 tBUT 13.9 versus 7.86 seconds; Schirmer 30.9 versus 15.86 mm; at least mild OSDI symptoms 26.6% versus 42.8%", "result_level": "Day-60 open-label completer context in cataract surgery patients without pre-existing dry eye, distinguished from direct treatment, symptom, quality-of-life and long-term outcomes in general chronic dry eye", "source_evidence_date": "2026-09-07", "materials": [ { "material_type": "Stored summary", "public_status": "Preserved copy of the complete parent-verdict stored summary", "access_status": "Summary read", "acquired": true, "actually_read": "Summary read", "as_of": "2026-09-07", "qualification": "The original PubMed URL, PMCID bibliography and unrecorded registration-identifier state are preserved. No new reading, access, prespecification or condition fulfillment is certified; full-text/registration URLs are not inferred." }, { "material_type": "Abstract", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "The original PubMed URL, PMCID bibliography and unrecorded registration-identifier state are preserved. No new reading, access, prespecification or condition fulfillment is certified; full-text/registration URLs are not inferred." }, { "material_type": "Full paper", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "The original PubMed URL, PMCID bibliography and unrecorded registration-identifier state are preserved. No new reading, access, prespecification or condition fulfillment is certified; full-text/registration URLs are not inferred." }, { "material_type": "Registration material", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "The original PubMed URL, PMCID bibliography and unrecorded registration-identifier state are preserved. No new reading, access, prespecification or condition fulfillment is certified; full-text/registration URLs are not inferred." }, { "material_type": "Protocol", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "The original PubMed URL, PMCID bibliography and unrecorded registration-identifier state are preserved. No new reading, access, prespecification or condition fulfillment is certified; full-text/registration URLs are not inferred." }, { "material_type": "Statistical analysis plan", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "The original PubMed URL, PMCID bibliography and unrecorded registration-identifier state are preserved. No new reading, access, prespecification or condition fulfillment is certified; full-text/registration URLs are not inferred." }, { "material_type": "Result tables and population/eye/harms records", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "The original PubMed URL, PMCID bibliography and unrecorded registration-identifier state are preserved. No new reading, access, prespecification or condition fulfillment is certified; full-text/registration URLs are not inferred." }, { "material_type": "Funding/conflict-of-interest disclosures", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "The original PubMed URL, PMCID bibliography and unrecorded registration-identifier state are preserved. No new reading, access, prespecification or condition fulfillment is certified; full-text/registration URLs are not inferred." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/26557550/" } ] } ], "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 records of methodological application were referenced. Methodological source content was not newly reviewed in this work." }, { "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 records of methodological application were referenced. Methodological source content was not newly reviewed in this work." }, { "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 records of methodological application were referenced. Methodological source content was not newly reviewed in this work." }, { "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 records of methodological application were referenced. Methodological source content was not newly reviewed in this work." }, { "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 records of methodological application were referenced. Methodological source content was not newly reviewed in this work." } ], "status_dictionary": { "Met": "The original content has been reviewed as meeting the conditions. This status is not used in this preparation.", "Partly verified": "Some information in the stored summary was linked during preparation; clinical verification or review is not complete.", "Unverified": "Required direct values, definitions or materials have not been established within the current storage and reading scope. This does not mean zero effect, no papers or failed access.", "Review incomplete": "Review of existing content or actual review incomplete.", "Not reported": "Used only when original materials were actually read and the outcome was judged unreported. Not used for external materials unread in this work.", "Inaccessible": "Used only when an actual access attempt has a recorded failure. Not used for access that was not attempted in this work.", "Insufficient evidence for the conditions": "Indicates insufficient direct materials for the relevant scope or conditions; it is not a new grade.", "Not applicable": "Used when the reason it does not apply to the original question is stated.", "Conflicting data": "Retains the scope of conflicting statements in original materials; it is not an arbitrary reassessment." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "Parent verdict 2987 and two subclaim sheets share the postoperative cataract study in the single Devendra and Singh 2015 report. Original 64 randomized, 58 completers, 32 allocated per group, 28 and 30 analyzed and 6 noncompleters are retained; people, eyes, repeated tests, conditions, times and sheets are not added as independent trials or participants. tBUT/Schirmer tests are distinguished from OSDI symptom proportions, and day-60 postoperative results from general chronic dry eye. Confirmed unique-trial, participant and independent-replication totals remain unrecorded." }, "history": [ { "date": "2026-10-16", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "The public page and data were prepared from the existing 40 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-16" }