[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100510514":3},{"organization":4,"outcomesModule":7,"designInfo":13,"detailedDescription":11,"studyPopulation":11,"armGroups":20,"interventions":30,"overallOfficials":11,"centralContacts":11,"locations":37,"responsibleParty":58,"collaborators":11,"id":60,"slug":11,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":11,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":11,"enrollmentInfo":68,"targetDuration":11,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":11,"overallStatus":40,"whyStopped":11,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"BRIM Biotechnology Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":11,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Proportion of patients achieving complete healing of the PED or corneal ulcer determined by corneal fluorescein staining",null,"at or before 4 weeks",{"allocation":14,"interventionModel":15,"interventionModelDescription":16,"primaryPurpose":17,"observationalModel":11,"timePerspective":11,"maskingInfo":18},"RANDOMIZED","PARALLEL","Open-label, Randomized Study","TREATMENT",{"masking":19,"maskingDescription":11,"whoMasked":11},"NONE",[21,26],{"label":22,"type":23,"description":11,"interventionNames":24},"BRM424 Ophthalmic Solution - Dose1","ACTIVE_COMPARATOR",[25],"Drug: BRM424 Ophthalmic Solution - Dose1",{"label":27,"type":23,"description":11,"interventionNames":28},"BRM424 Ophthalmic Solution - Dose2",[29],"Drug: BRM424 Ophthalmic Solution - Dose2",[31,35],{"type":32,"name":22,"description":33,"armGroupLabels":34,"otherNames":11},"DRUG","A topical drop of BRM424 ophthalmic solution.",[22],{"type":32,"name":27,"description":33,"armGroupLabels":36,"otherNames":11},[27],[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Wilmington Eye","RECRUITING","Leland","North Carolina","28451","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-78.04471,34.25628,{"lat":50,"lon":49},[53],{"name":54,"role":55,"phone":56,"phoneExt":11,"email":57},"Crystal Wong","CONTACT","910-763-3601","cwong@wilmingtoneye.co",{"type":59,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100510514",false,"NCT05927428","Assessment of the Initial Efficacy and Safety of BRM424 Ophthalmic Solutions in Patients With Neurotrophic Keratitis","An Open-Label, Multi-Center, Phase 2 Dose Ranging Study of BRM424 Ophthalmic Solution in Patients With Neurotrophic Keratitis (NK)","Inclusion Criteria:\n\n* Be at least 18 years of age;\n* Provide written informed consent;\n* Patients with NK Stage 2 (PED) or Stage 3 (corneal ulcer);\n\nExclusion Criteria:\n\n* Any active ocular infection (bacterial, viral, fungal or protozoal) or active ocular inflammation not related to NK;\n* Anticipated need to use therapeutic contact lenses or contact lens wear for refractive correction during the 28-days Treatment Period in the eye(s) with NK;\n* Be a woman of childbearing potential who is not using an acceptable means of birth control;","ALL","18 Years",{"count":69,"type":70},12,"ESTIMATED","INTERVENTIONAL",[73],"PHASE2","The objective of this study is to obtain initial efficacy of BRM424 in patients with Stage 2 and Stage 3 NK and evaluate safety and tolerability.",[76],"Neurotrophic Keratitis","2024-10-24",{"date":79,"type":80},"2024-10-28","ACTUAL",{"date":82,"type":80},"2024-07-31",{"date":84,"type":70},"2025-11-30",{"name":5,"class":6},1]