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Multi-Center, Prospective, Non-Interventional Study in Subjects With Limbal Stem Cell Deficiency
RecruitingObservational study
A Multi-Center, Prospective, Non-Interventional Study in Subjects With Limbal Stem Cell Deficiency
Who can join
Ages 12 to 99 · All sexes
Full eligibility criteria
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.
About the study
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).
What is being tested
- Non-interventional (other)
Sponsor: Claris Biotherapeutics, Inc. · Participants: 500 · Started: May 22, 2026
Contact the study team
- Central Operations Representative · Phone: 949-354-1299
Official record on ClinicalTrials.gov — NCT07636590
Locations in the U.S.
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.