[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07636590":3,"trial-entities:NCT07636590":123,"trial-summary:NCT07636590":127},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":17,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":31,"secondary_outcomes":51,"sex":73,"minimum_age":74,"maximum_age":75,"healthy_volunteers":15,"eligibility_criteria":76,"std_ages":87,"locations":91,"central_contacts":116,"overall_officials":120,"references":121,"see_also_links":122},"NCT07636590","CSB-C26-001","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","RECRUITING","2028-03","2026-07","2026-07-28","2026-05-22","Claris Biotherapeutics, Inc.","INDUSTRY",false,"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).",null,[19],"Limbal Stem Cell Deficiency",[],"OBSERVATIONAL",[],{"count":24,"type":25},500,"ESTIMATED",[27],{"type":28,"name":29,"description":29,"armGroupLabels":30},"OTHER","Non-interventional",[29],[32,36,39,42,45,48],{"measure":33,"description":34,"timeFrame":35},"Natural Progression of LSCD as Assessed by Changes in Patient Reported Outcomes","Onset or changes (worsening or improving) in vision-related quality of life and ocular symptoms as captured with the National Eye Institute Visual Function Questionnaire-25 (VFQ-25) and Ocular Surface Disease Index (OSDI) questionnaires","Screening through Week 84",{"measure":37,"description":38,"timeFrame":35},"Natural Progression of LSCD as Assessed by Functional Changes (Photophobic BCVA)","Change in photophobic BCVA",{"measure":40,"description":41,"timeFrame":35},"Natural Progression of LSCD as Assessed by Functional Changes (Low-luminance BCVA)","Change in low-luminance BCVA",{"measure":43,"description":44,"timeFrame":35},"Natural Progression of LSCD as Assessed by Functional Changes (Low-contrast BCVA)","Change in low-contrast BCVA",{"measure":46,"description":47,"timeFrame":35},"Natural Progression of LSCD as Assessed by Functional Changes (Contrast Sensitivity)","Change in contrast sensitivity (Pelli-Robson)",{"measure":49,"description":50,"timeFrame":35},"Natural Progression of LSCD as Assessed by Anatomical\u002FStructural Changes","Change in area of central cornea conjunctivalization",[52,55,58,61,64,67,70],{"measure":53,"description":54,"timeFrame":35},"Changes that May be Correlated with LSCD as Assessed by Functional Changes (Corneal Sensitivity)","Changes (onset, improvement, or worsening) in corneal sensitivity",{"measure":56,"description":57,"timeFrame":35},"Changes that May be Correlated with LSCD as Assessed by Anatomical Changes (Corneal Topography\u002FTomography)","Changes (onset, improvement, or worsening) in corneal topography and\u002For tomography and\u002For densitometry",{"measure":59,"description":60,"timeFrame":35},"Changes that May be Correlated with LSCD as Assessed by Anatomical Changes (Epithelial Defect Frequency)","Changes (onset, improvement, or worsening) in epithelial defect frequency",{"measure":62,"description":63,"timeFrame":35},"Changes that May be Correlated with LSCD as Assessed by Anatomical Changes (Palisades of Vogt Crypts)","Changes (onset, improvement, or worsening) in Palisades of Vogt crypts",{"measure":65,"description":66,"timeFrame":35},"Changes that May be Correlated with LSCD as Assessed by Anatomical Changes (Epithelial and Total Corneal Thickness)","Changes (onset, improvement, or worsening) in epithelial and total corneal thickness",{"measure":68,"description":69,"timeFrame":35},"Changes that May be Correlated with LSCD as Assessed by Anatomical Changes (Pannus)","Changes (onset, improvement, or worsening) in pannus",{"measure":71,"description":72,"timeFrame":35},"Changes that May be Correlated with LSCD as Assessed by Changes Ocular and Systemic Health Outcome Measures","Changes (onset, improvement\u002Fresolution, or worsening) of an existing condition","ALL","12 Years","99 Years",{"inclusion":77,"exclusion":82,"raw_text":86},[78,79,80,81],"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","Qualifying LSCD diagnosis in the study eye(s) prior to enrollment at Day 1","Written confirmation that exclusions on retinal findings are met in the study eye(s) prior to enrollment at Day 1","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.",[83,84,85],"Any active ocular infection in either eye at either the Screening or Day 1 visits","Active sterile iritis or uveitis in either eye at Screening or Day 1 visits","Screening visit retinal exam finding, in the opinion of the investigator, that would limit potential for visual acuity gain in the study eye(s)","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.",[88,89,90],"CHILD","ADULT","OLDER_ADULT",[92,107],{"facility":93,"status":8,"city":94,"state":95,"zip":96,"country":97,"contacts":98,"geoPoint":104},"Claris Investigative Site","Carmel","Indiana","46290","United States",[99,102],{"name":100,"role":101},"Study Coordinator","CONTACT",{"role":101,"phone":103},"919-205-0012",{"lat":105,"lon":106},39.97837,-86.11804,{"facility":93,"status":8,"city":108,"state":95,"zip":109,"country":97,"contacts":110,"geoPoint":113},"Indianapolis","46260",[111,112],{"name":100,"role":101},{"role":101,"phone":103},{"lat":114,"lon":115},39.76838,-86.15804,[117],{"name":118,"role":101,"phone":103,"email":119},"Central Operations Representative","clinicaltrials@clarisbio.com",[],[],[],{"nct_id":4,"conditions":124,"biomarkers":126},[125],"Limbal stem cell deficiency",[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]