NCT07636590 Multi-Center, Prospective, Non-Interventional Study in Subjects With Limbal Stem Cell Deficiency
| NCT ID | NCT07636590 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Claris Biotherapeutics, Inc. |
| Condition | Limbal Stem Cell Deficiency |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2026-05-22 |
| Primary Completion | 2028-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2026-05-22 with a primary completion date of 2028-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07636590 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 99 Years, studying Limbal Stem Cell Deficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07636590 currently recruiting?
Yes, NCT07636590 is actively recruiting participants. Contact the research team at clinicaltrials@clarisbio.com for enrollment information.
Where is the NCT07636590 trial being conducted?
This trial is being conducted at Carmel, United States, Indianapolis, United States.
Who is sponsoring the NCT07636590 clinical trial?
NCT07636590 is sponsored by Claris Biotherapeutics, Inc.. The trial plans to enroll 500 participants.