NCT07636590Recruiting
Multi-Center, Prospective, Non-Interventional Study in Subjects With Limbal Stem Cell Deficiency
Claris Biotherapeutics, Inc.
Start Date
5/22/2026
Completion Date
3/1/2028
Summary
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).
Eligibility Criteria
Age Range: 12 years to 99 years
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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)
Note: Other inclusion/exclusion criteria apply.
Interventions
OTHER
Non-interventional
Conditions
Limbal Stem Cell Deficiency
Locations
Claris Investigative Site
Carmel, Indiana 46290
United States
Claris Investigative Site
Indianapolis, Indiana 46260
United States