[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Claris Biotherapeutics, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":86},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,39,63],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100642892","multi-center-prospective-non-interventional-study-in-subjects-with-limbal-stem-cell-deficiency-100642892",false,"NCT07636590","Multi-Center, Prospective, Non-Interventional Study in Subjects With Limbal Stem Cell Deficiency","A Multi-Center, Prospective, Non-Interventional Study in Subjects With Limbal Stem Cell Deficiency","Inclusion Criteria:\n\n* A photopic BCVA in the prospective study eye(s) of ≤ 70 letters at the Screening and Day 1 visits AND a change of ≤ 10 letters in photopic BCVA at Day 1 compared to the Screening Visit\n* Qualifying LSCD diagnosis in the study eye(s) prior to enrollment at Day 1\n* Written confirmation that exclusions on retinal findings are met in the study eye(s) prior to enrollment at Day 1\n* Inflammation associated with LSCD or other non-infectious inflammation (e.g., dry eye, ocular rosacea, and blepharitis) that will not interfere with the subject's participation in the opinion of the investigator is permitted.\n\nExclusion Criteria:\n\n* Any active ocular infection in either eye at either the Screening or Day 1 visits\n* Active sterile iritis or uveitis in either eye at Screening or Day 1 visits\n* Screening visit retinal exam finding, in the opinion of the investigator, that would limit potential for visual acuity gain in the study eye(s)\n\nNote: Other inclusion\u002Fexclusion criteria apply.","ALL","12 Years","99 Years",{"count":20,"type":21},500,"ESTIMATED","OBSERVATIONAL","The goal of this non-interventional, observational study is to describe the natural history, clinical course, and management patterns of subjects with limbal stem cell deficiency (LSCD).",[25],"Limbal Stem Cell Deficiency","RECRUITING","2026-06-03",{"date":29,"type":30},"2026-06-09","ACTUAL",{"date":32,"type":30},"2026-05-22",{"date":34,"type":21},"2028-03",{"name":36,"class":37},"Claris Biotherapeutics, Inc.","INDUSTRY",2,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":62},"100550841","phase-1-study-to-evaluate-the-safety-and-efficacy-of-csb-001-ophthalmic-solution-01-in-subjects-with-limbal-stem-cell-deficiency-100550841","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.","18 Years",{"count":48,"type":21},75,"INTERVENTIONAL",[51],"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).",[25],"2026-04-27",{"date":56,"type":30},"2026-04-30",{"date":58,"type":30},"2024-05-15",{"date":60,"type":21},"2027-12-31",{"name":36,"class":37},6,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":70,"enrollmentInfo":71,"targetDuration":4,"studyType":49,"phases":73,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},"100535863","phase-1-study-to-evaluate-the-safety-and-efficacy-of-csb-001-ophthalmic-solution-01-in-subjects-with-corneal-scars-100535863","NCT06257355","Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Corneal Scars","A Two-Arm Open-Label Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Corneal Scars","Inclusion Criteria:\n\n* Centrally or paracentrally located scar approximately ≤5 mm and ≥2 mm in the greatest diameter and with a portion of the scar within approximately 3.5 mm of the optical center of the cornea assessed at Screening and confirmed at Baseline, and subject reports ability to detect any effect of scar on any element of vision.\n* Eye with a recent corneal insult approximately ≤30 days and ≥7 days from the Screening Visit.\n* Corneal insult includes but is not limited to mechanical \u002F chemical \u002F thermal injury, bacterial keratitis, PRK, and contact lens related ulcer.\n* Eye with observed rate of epithelialization that in the investigator's opinion does not demonstrate clinical characteristics of a slow healing (persistent defect) cornea.\n* Subjects must have the ability and willingness to comply with study procedures.\n\nExclusion Criteria:\n\n* Corneal scar that encompasses more than approximately 50% of the depth of the remaining stroma as guided by ASOCT image at the Screening Visit.\n* Maximum scar diameter greater than approximately 5 mm without prior approval by the Sponsor based on Screening Visit images.\n* No portion of the scar is within the approximate 3.5 mm of the optical center of the cornea based on Screening Visit images.\n* Any active ocular infection in the opinion of the investigator (bacterial, viral, fungal, or protozoal) at the Screening or Day 1 Visits. Subjects with an active bacterial infection at the Screening or Day 1 Visit in the opinion of the investigator may be rescheduled to reassess the status of the infection and continue in the study if infection is deemed not active.\n* Ocular surgery planned during the study treatment period.\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, could possibly interfere with the interpretation of study results, or could be judged by the investigator to be incompatible with the study visit schedule or conduct.\n\nNote: Other inclusion\u002Fexclusion criteria apply.","80 Years",{"count":72,"type":21},20,[51],"This study will enroll subjects with recently formed corneal scars that resulted from a corneal insult presenting and diagnosed within the past approximately 30 days and not less than approximately 7 days. All subjects will be assigned to CSB-001 investigational treatment on Day 1. All subjects will dose with CSB-001 four times daily or three times daily starting on Day 1 and continue until Day 14. Subjects with a resolved scar at Day 7 will discontinue dosing and return to the clinic on Day 14. Subjects will return on Days 21, 28, 56, and Month 3 for safety and efficacy assessments.",[76],"Corneal Scar","2026-04-01",{"date":79,"type":30},"2026-04-07",{"date":81,"type":30},"2024-02-05",{"date":83,"type":21},"2027-06-30",{"name":36,"class":37},7,""]