[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636872":3},{"organization":4,"outcomesModule":7,"designInfo":53,"detailedDescription":59,"studyPopulation":52,"armGroups":60,"interventions":67,"overallOfficials":73,"centralContacts":77,"locations":83,"responsibleParty":101,"collaborators":52,"id":104,"slug":52,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":52,"eligibilityCriteria":109,"healthyVolunteers":105,"sex":110,"minAge":111,"maxAge":52,"enrollmentInfo":112,"targetDuration":52,"studyType":115,"phases":116,"briefSummary":117,"conditions":118,"keywords":121,"overallStatus":86,"whyStopped":52,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"Universidad Autonoma de Nuevo Leon","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":52},[9],{"measure":10,"description":11,"timeFrame":12},"1. Effectiveness","To evaluate signs and symptoms of dry eye, after superior lacrimal punctal occlusion with plug in patients with aqueous-deficient dry eye who have previously occlusion of the inferior lacrimal punctum at baseline, 2 weeks, 4 weeks, 3 months and 6 months","Baseline, 2 weeks, 4 weeks, 3 months and 6 months",[14,18,21,24,27,30,33,36,39,42,45,49],{"measure":15,"description":16,"timeFrame":17},"Change in lower tear meniscus heigh","Change in lower tear meniscus height measured using Keratograph and optical coherence tomography (OCT) after upper punctal plug placement.","Baseline to 3 months after upper punctal plug placement.",{"measure":19,"description":20,"timeFrame":17},"Change in lower tear meniscus area","Change in lower tear meniscus area measured using Keratograph and optical coherence tomography (OCT) after upper punctal plug placement.",{"measure":22,"description":23,"timeFrame":17},"Change from baseline in dry eye severity as assessed by the Ocular Surface Disease Index (OSDI)","The OSDI is a validated 12-item questionnaire evaluating dry eye symptoms and their impact on vision-related functioning across three domains: ocular symptoms, visual function, and environmental triggers. Each item is scored on a 5-point scale (0 = none of the time to 4 = all of the time). The total OSDI score is calculated as:\n\nOSDI= number of questions answered (sum of scores)×25\n\nScores range from 0 to 100, with higher scores indicating greater disability. Severity categories are: normal (0-12), mild (13-22), moderate (23-32), and severe (33-100).",{"measure":25,"description":26,"timeFrame":17},"Change from baseline in dry eye symptoms as assessed by the Symptom Assessment in Dry Eye (SANDE) scale.","The SANDE is a validated, patient-reported outcome measuring dry eye symptom burden using two 100-mm visual analog scales assessing frequency and severity of symptoms (0 = none, 100 = maximal). The composite SANDE score is calculated as the square root of the product of frequency and severity scores:\n\nHigher scores indicate worse symptoms.",{"measure":28,"description":29,"timeFrame":17},"Change in tear film break-up time (TFBUT).","Change in tear film break-up time measured with fluorescein after upper punctal plug placement.",{"measure":31,"description":32,"timeFrame":17},"Change in non-invasive tear break-up time (NIBUT).","Change in non-invasive tear break-up time measured using Keratograph after upper punctal plug placement.",{"measure":34,"description":35,"timeFrame":17},"Change from baseline in ocular surface damage as assessed by the SICCA Ocular Surface Staining Score (OSS).","The SICCA OSS is a standardized clinical grading system developed by the Sjögren's International Collaborative Clinical Alliance to quantify ocular surface epithelial damage using vital dyes. The score combines fluorescein corneal staining and lissamine green conjunctival staining in each eye.",{"measure":37,"description":38,"timeFrame":17},"Change from baseline in corneal epithelial damage as assessed by the National Eye Institute Corneal Fluorescein Staining (NEI) score","The NEI corneal fluorescein staining score is a standardized slit-lamp-based grading system used to quantify corneal epithelial damage after fluorescein instillation. The cornea is divided into five regions (central, superior, inferior, nasal, and temporal). Each region is graded on a 0 to 3 scale based on staining density and extent:\n\n0 = no staining\n\n1. = sparse punctate staining\n2. = moderate\u002Fdense punctate staining\n3. = severe staining or coalescent areas\n\nThe total NEI score is the sum of all regions, ranging from 0 to 15, with higher scores indicating greater corneal epithelial damage.",{"measure":40,"description":41,"timeFrame":17},"Change in Schirmer I test results.","Change in tear production measured using the Schirmer I test with and without anesthesia after upper punctal plug placement.",{"measure":43,"description":44,"timeFrame":17},"Change in corneal sensitivity.","Change in corneal sensitivity measured by corneal esthesiometry after upper punctal plug placement.",{"measure":46,"description":47,"timeFrame":48},"Incidence of epiphora after upper punctal plug placement.","Incidence of epiphora reported after upper punctal plug placement during the follow-up period.","Up to 3 months after upper punctal plug placement.",{"measure":50,"description":51,"timeFrame":48},"Upper punctal plug retention rate.","Proportion of upper punctal plugs remaining in place during the follow-up period after placement.",null,{"allocation":54,"interventionModel":55,"interventionModelDescription":56,"primaryPurpose":6,"observationalModel":52,"timePerspective":52,"maskingInfo":57},"NA","SINGLE_GROUP","Prospective, consecutive, interventional case series study of patients with aqueous-deficient dry eye disease.",{"masking":58,"maskingDescription":52,"whoMasked":52},"NONE","This prospective, consecutive, interventional, longitudinal, case series study includes patients with aqueous-deficient dry eye disease who have inferior punctal occlusion. The study aims to evaluate the effect of superior lacrimal punctal occlusion with a plug dry eye symptoms and signs. Assessments will be performed at baseline and at 2 weeks, 4 weeks, 3 months, and 6 months following superior punctal occlusion",[61],{"label":62,"type":63,"description":64,"interventionNames":65},"1 arm, superior lacrimal punctal occlusion with plug in patients with aqueous-deficient dry eye who","EXPERIMENTAL","1 arm, superior lacrimal punctal occlusion with plug in patients with aqueous-deficient dry eye who have previously occlusion of the inferior lacrimal punctum.",[66],"Procedure: Punctal plug occlusion",[68],{"type":69,"name":70,"description":71,"armGroupLabels":72,"otherNames":52},"PROCEDURE","Punctal plug occlusion","Superior lacrimal punctal occlusion with plug in patients with aqueous-deficient dry eye who have previously occlusion of the inferior lacrimal punctum.",[62],[74],{"name":75,"affiliation":5,"role":76},"Karim Mohamed-Noriega, Dr. med.","PRINCIPAL_INVESTIGATOR",[78],{"name":75,"role":79,"phone":80,"phoneExt":81,"email":82},"CONTACT","+52 8113404960","8514","karim.mohamednr@uanl.edu.mx",[84],{"facility":85,"status":86,"city":87,"state":88,"zip":89,"country":90,"countryCode":91,"cosmosGeoPoint":92,"geoPoint":97,"contacts":98},"Ophthalmology Department","RECRUITING","Monterrey","Nuevo León","64460","Mexico","MX",{"type":93,"coordinates":94},"Point",[95,96],-100.31721,25.68435,{"lat":96,"lon":95},[99],{"name":75,"role":79,"phone":80,"phoneExt":81,"email":100},"karim.mohamednrg@uanl.edu.mx",{"type":76,"investigatorFullName":102,"investigatorTitle":103,"investigatorAffiliation":5,"oldNameTitle":52,"oldOrganization":52},"Karim Mohamed-Noriega","Principal Investigator","100636872",false,"NCT07571330","Upper Punctal Plug Occlusion in Previous Lower Punctal Occlusion.","Effectiveness of Upper Punctal Plug Occlusion in Patients With Dry Eye Disease With Previous Lower Punctal Occlusion.","Inclusion Criteria:\n\n* Patients of both sexes\n* One or both eyes may be included\n* Inferior lacrimal punctum occluded (with a punctal plug or cauterization), clinically sealed under slit-lamp examination\n* Functional superior lacrimal punctum\n* Aqueous-deficient dry eye (such as Sjögren's disease, graft-versus-host disease, or primary dry eye disease.)\n* Age \\>18 years\n* OSDI score \\>13 and one of the following signs: Tear film markers (Fluorescein tear break up-time \\\u003C5, First non-invasive tear breakup time \\\u003C10, Schirmer test without anesthesia \\\u003C10 mm, Schirmer test with anesthesia \\\u003C10 mm), Ocular surface markers (corneal staining \\>5 spots or conjunctival staining \\>9 spots).\n\nExclusion Criteria:\n\n* Active ocular surface infection.\n* Patients who are unwilling to participate or to provide written informed consent.","ALL","18 Years",{"count":113,"type":114},36,"ESTIMATED","INTERVENTIONAL",[54],"This study evaluates the therapeutic effect of upper punctal plug occlusion in patients with dry eye disease with previous lower punctal occlusion.",[119,120],"DED","Aqueous-deficient Dry Eye Disease",[122,119,123,124],"Aqueous-deficient dry eye disease","Punctual plug","Superior punctual plug","2026-05-04",{"date":127,"type":128},"2026-05-06","ACTUAL",{"date":130,"type":128},"2026-02-12",{"date":132,"type":114},"2026-11-01",{"name":5,"class":6},1]