[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649140":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":31,"responsibleParty":44,"collaborators":20,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":20,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":20,"enrollmentInfo":55,"targetDuration":20,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":33,"whyStopped":20,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"NYU Langone Health","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Dry Eye Disease","EXPERIMENTAL","Participants will be treated with the TRYPTYR drug for one month",[13],"Drug: TRYPTYR (Acoltremon ophthalmic solution 0.003%)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","TRYPTYR (Acoltremon ophthalmic solution 0.003%)","TRYPTYR will be administered one drop in each eye twice daily (once every 12 hours) for 30 days.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Giacomina Massaro-Giordano, MD","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Jamika Singleton-Garvin","CONTACT","929-455-5522","Jamika.Singleton-Garvin@nyulangone.org",[32],{"facility":5,"status":33,"city":34,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":20},"RECRUITING","New York","10016","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-74.00597,40.71427,{"lat":42,"lon":41},{"type":45,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100649140","phase-4-tryptyr-as-a-treatment-for-patients-with-dry-eye-disease-ded-100649140",false,"NCT07732010","TRYPTYR as a Treatment for Patients With Dry Eye Disease (DED)","A Single Center Investigator Initiated Trial Using TRYPTYR as a Treatment for Patients With Dry Eye Disease","Inclusion Criteria:\n\n1. Adults (18 and older)\n2. Ability to provide informed consent and to understand the study procedures\n3. Patients diagnosed with dry eye disease\n4. Presence of dry eye symptoms determined by a validated questionnaire (OSDI- Attachment 1) with scores above a specified threshold AND\n5. Tear film break-up time (TBUT) below a set value (less than 8 seconds)\n6. Schirmer test (w\u002Fo drops) value below a set cut-off (less than 10 mm)\n7. Positive findings on ocular surface staining (NEI \\>\u002Fequal 3)\n8. Positive conjunctival staining (NEI \\>4)\n9. Moderate meibomian gland dysfunction (MGD)\n\nExclusion Criteria:\n\n* History or presence of any ocular disorder or condition (other than DED) in either eye that would, in the opinion of the investigator, interfere with the interpretation of the study results or subject safety\n* History of ocular surgery within 3 months prior to the Screening visit, including punctal cautery, corneal refractive, or anterior segment surgeries that affect corneal sensitivity (e.g., cataract surgery or any surgery involving limbal or corneal incision) or lid surgery\n* Have had a corneal transplant in either or both eyes\n* Patients with current steroid use\n* Pregnancy","ALL","18 Years",{"count":56,"type":57},50,"ESTIMATED","INTERVENTIONAL",[60],"PHASE4","The purpose of this research study is to determine the effectiveness of TRYPTYR as a treatment for Dry Eye Disease. The primary efficacy variable is change from baseline in the Ocular Surface Disease Index (OSDI) at week 2. The co-primary efficacy variables are change from baseline in the National Eye Institute (NEI) scale of the cornea and NEI scale of the conjunctiva at 1 month (the third visit).",[63],"Dry Eye Disease (DED)",[65,66],"DED","TRYPTYR","2026-07-23",{"date":69,"type":70},"2026-07-28","ACTUAL",{"date":72,"type":70},"2026-07-06",{"date":74,"type":57},"2027-05-25",{"name":5,"class":6},1]