[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550841":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":25,"locations":31,"responsibleParty":108,"collaborators":24,"id":110,"slug":111,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":24,"eligibilityCriteria":116,"healthyVolunteers":112,"sex":117,"minAge":118,"maxAge":24,"enrollmentInfo":119,"targetDuration":24,"studyType":122,"phases":123,"briefSummary":125,"conditions":126,"keywords":24,"overallStatus":34,"whyStopped":24,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},{"fullName":5,"class":6},"Claris Biotherapeutics, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control","EXPERIMENTAL","Period I: Subjects will be observed (non-interventional) for 20 weeks. Period II: Subjects will be dosed one drop CSB-001 four times daily for two 8-week dosing periods in the study eye(s) separated by \\>30 days and \\\u003C40 days (dosing holiday) followed by observation (non-interventional) to Week 48. Period III: Subjects may elect to participate in the Observation Extension Phase (non-interventional) for an additional 36 months to Week 144.",[13],"Biological: CSB-001 Ophthalmic Solution 0.1%",{"label":15,"type":10,"description":16,"interventionNames":17},"CSB-001 QID","Period I: Subjects will be dosed one drop CSB-001 four times daily for two 8-week dosing periods in the study eye(s) separated by \\>30 days and \\\u003C40 days (dosing holiday) followed by observation (non-interventional) to Week 20. Period II: Subject will be observed (non-interventional) for 28 weeks to Week 48. Period III: Subjects may elect to participate in the Observation Extension Phase (non-interventional) for an additional 36 months to Week 144.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"BIOLOGICAL","CSB-001 Ophthalmic Solution 0.1%","CSB-001: human recombinant dHGF (5-amino acid deleted hepatocyte growth factor)",[15,9],null,[26],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},"Central Operations Representative","CONTACT","919-354-1299","clinicaltrials@clarisbio.com",[32,49,61,72,84,96],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Loma Linda University Eye Institute","RECRUITING","Loma Linda","California","92354","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-117.26115,34.04835,{"lat":44,"lon":43},[47],{"name":48,"role":28,"phone":24,"phoneExt":24,"email":24},"Study Coordinator",{"facility":50,"status":34,"city":51,"state":52,"zip":53,"country":38,"countryCode":39,"cosmosGeoPoint":54,"geoPoint":58,"contacts":59},"Midwest Cornea Associates, LLC","Carmel","Indiana","46290",{"type":41,"coordinates":55},[56,57],-86.11804,39.97837,{"lat":57,"lon":56},[60],{"name":48,"role":28,"phone":24,"phoneExt":24,"email":24},{"facility":62,"status":34,"city":63,"state":52,"zip":64,"country":38,"countryCode":39,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Francis Price Jr, MD","Indianapolis","46260",{"type":41,"coordinates":66},[67,68],-86.15804,39.76838,{"lat":68,"lon":67},[71],{"name":48,"role":28,"phone":24,"phoneExt":24,"email":24},{"facility":73,"status":34,"city":74,"state":75,"zip":76,"country":38,"countryCode":39,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Minnesota Eye Consultants","Minnetonka","Minnesota","55305",{"type":41,"coordinates":78},[79,80],-93.50329,44.9133,{"lat":80,"lon":79},[83],{"name":48,"role":28,"phone":24,"phoneExt":24,"email":24},{"facility":85,"status":34,"city":86,"state":87,"zip":88,"country":38,"countryCode":39,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Legacy Devers Eye Institute","Portland","Oregon","97210",{"type":41,"coordinates":90},[91,92],-122.67621,45.52345,{"lat":92,"lon":91},[95],{"name":48,"role":28,"phone":24,"phoneExt":24,"email":24},{"facility":97,"status":34,"city":98,"state":99,"zip":100,"country":38,"countryCode":39,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Stuart A. Terry, MD PA","San Antonio","Texas","78212",{"type":41,"coordinates":102},[103,104],-98.49363,29.42412,{"lat":104,"lon":103},[107],{"name":48,"role":28,"phone":24,"phoneExt":24,"email":24},{"type":109,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100550841","phase-1-study-to-evaluate-the-safety-and-efficacy-of-csb-001-ophthalmic-solution-01-in-subjects-with-limbal-stem-cell-deficiency-100550841",false,"NCT06452316","Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Limbal Stem Cell Deficiency","An Open-Label Study Evaluating the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Limbal Stem Cell Deficiency","Inclusion Criteria:\n\n* Have an area of the central 5 mm zone of cornea affected, presence of at least one clinical sign observed by slit-lamp examination with white light and\u002For cobalt blue light, fluorescein, and a Wratten filter, and at least one clinical sign observed with AS-OCT.\n* If dosing with Acthar at time of Screening Visit, must have a history of stable dosing for approximately 8 weeks, plan to maintain the same Acthar treatment dose and regimen, and have demonstrated little to no improvement in severity of LSCD.\n* Sponsor written confirmation of qualifying LSCD diagnosis.\n* Inflammation associated with LSCD or other non-infectious inflammation that will not interfere with subject's participation.\n\nExclusion Criteria:\n\n* Any active ocular infection (bacterial, viral, fungal, or protozoan) in either eye.\n* Ocular surgery within 30 days of Day 0 where investigator assesses that healing is not considered complete\u002Fstable.\n* Planned ocular surgery on or before Week 20 visit.\n* Presence or history of any ocular or systemic disorder, condition, or procedure that might hinder the efficacy of the study treatment or its evaluation, or could interfere with the interpretation of study results, in the opinion of the investigator.\n\nNote: Other inclusion\u002Fexclusion criteria apply.","ALL","18 Years",{"count":120,"type":121},75,"ESTIMATED","INTERVENTIONAL",[124],"PHASE1","This study will enroll subjects with qualifying limbal stem cell deficiency (LSCD). All subjects will receive CSB-001 investigational drug in either one or both study eyes. The study is comprised of two identical phases (Dosing Phase I and II) of test article dosing separated by a 31- to 40-day period, the Dosing Holiday, where no test article is administered. Dosing Phase II is followed by an observational, noninterventional phase (Observation Phase).",[127],"Limbal Stem Cell Deficiency","2026-04-27",{"date":130,"type":131},"2026-04-30","ACTUAL",{"date":133,"type":131},"2024-05-15",{"date":135,"type":121},"2027-12-31",{"name":5,"class":6},6]