Multi-Center, Prospective, Non-Interventional Study in Subjects With Limbal Stem Cell Deficiency (NCT07636590) | Clinical Trial Compass
RecruitingNot Applicable
Multi-Center, Prospective, Non-Interventional Study in Subjects With Limbal Stem Cell Deficiency
United States500 participantsStarted 2026-05-22
Plain-language 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).
Who can participate
Age range
12 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Natural Progression of LSCD as Assessed by Changes in Patient Reported Outcomes
Timeframe: Screening through Week 84
2
Natural Progression of LSCD as Assessed by Functional Changes (Photophobic BCVA)
Timeframe: Screening through Week 84
3
Natural Progression of LSCD as Assessed by Functional Changes (Low-luminance BCVA)
Timeframe: Screening through Week 84
4
Natural Progression of LSCD as Assessed by Functional Changes (Low-contrast BCVA)
Timeframe: Screening through Week 84
5
Natural Progression of LSCD as Assessed by Functional Changes (Contrast Sensitivity)
Timeframe: Screening through Week 84
6
Natural Progression of LSCD as Assessed by Anatomical/Structural Changes