Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Limbal Stem Cell Deficiency
Start Date
5/15/2024
Completion Date
12/31/2027
Summary
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).
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
CSB-001 Ophthalmic Solution 0.1%
Conditions
Locations
Loma Linda University Eye Institute
Loma Linda, California 92354
United States
Midwest Cornea Associates, LLC
Carmel, Indiana 46290
United States
Francis Price Jr, MD
Indianapolis, Indiana 46260
United States
Minnesota Eye Consultants
Minnetonka, Minnesota 55305
United States
Legacy Devers Eye Institute
Portland, Oregon 97210
United States
Stuart A. Terry, MD PA
San Antonio, Texas 78212
United States