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
Claris Investigative Site
Overland Park, Kansas 66204
United States
Claris Investigative Site
Louisville, Kentucky 40206
United States
Claris Investigative Site
Minnetonka, Minnesota 53052
United States
Claris Investigative Site
Portland, Oregon 97210
United States
Claris Investigative Site
Smyrna, Tennessee 37167
United States
Claris Investigative Site
San Antonio, Texas 78212
United States