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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

Sponsor: Claris Biotherapeutics, Inc. · Participants: 500 · Started: May 22, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07636590

Locations in the U.S.

IndianaClaris Investigative Site, Carmel
Claris Investigative Site, Indianapolis
KansasClaris Investigative Site, Overland Park
KentuckyClaris Investigative Site, Louisville
MinnesotaClaris Investigative Site, Minnetonka
OregonClaris Investigative Site, Portland
TennesseeClaris Investigative Site, Smyrna
TexasClaris Investigative Site, San Antonio

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.