Actively Recruiting
Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Limbal Stem Cell Deficiency
Led by Claris Biotherapeutics, Inc. · Updated on 2026-04-30
75
Participants Needed
6
Research Sites
189 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will enroll subjects with qualifying limbal stem cell deficiency (LSCD). All subjects will receive CSB-001 investigational drug in either one or both study eyes. The study is comprised of two identical phases (Dosing Phase I and II) of test article dosing separated by a 31- to 40-day period, the Dosing Holiday, where no test article is administered. Dosing Phase II is followed by an observational, noninterventional phase (Observation Phase).
CONDITIONS
Official Title
Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Limbal Stem Cell Deficiency
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have an area of the central 5 mm zone of cornea affected with at least one clinical sign observed by slit-lamp examination with white light and/or cobalt blue light, fluorescein, and a Wratten filter, and at least one clinical sign observed with AS-OCT
- If using Acthar at Screening, must have stable dosing for approximately 8 weeks, plan to maintain the same dose and regimen, and have little to no improvement in LSCD severity
- Sponsor written confirmation of qualifying LSCD diagnosis
- Inflammation associated with LSCD or other non-infectious inflammation that does not interfere with participation
You will not qualify if you...
- Any active ocular infection (bacterial, viral, fungal, or protozoan) in either eye
- Ocular surgery within 30 days of Day 0 where healing is not complete or stable
- Planned ocular surgery on or before Week 20 visit
- Any ocular or systemic disorder, condition, or procedure that might hinder treatment efficacy or evaluation, or interfere with results interpretation as assessed by investigator
- Note: Other inclusion/exclusion criteria apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Loma Linda University Eye Institute
Loma Linda, California, United States, 92354
Actively Recruiting
2
Midwest Cornea Associates, LLC
Carmel, Indiana, United States, 46290
Actively Recruiting
3
Francis Price Jr, MD
Indianapolis, Indiana, United States, 46260
Actively Recruiting
4
Minnesota Eye Consultants
Minnetonka, Minnesota, United States, 55305
Actively Recruiting
5
Legacy Devers Eye Institute
Portland, Oregon, United States, 97210
Actively Recruiting
6
Stuart A. Terry, MD PA
San Antonio, Texas, United States, 78212
Actively Recruiting
Research Team
C
Central Operations Representative
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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