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Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Limbal Stem Cell Deficiency
Sponsor: Claris Biotherapeutics, Inc.
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).
Official title: An Open-Label Study Evaluating the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Limbal Stem Cell Deficiency
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
65
Start Date
2024-05-15
Completion Date
2027-12-31
Last Updated
2026-04-07
Healthy Volunteers
No
Conditions
Interventions
CSB-001 Ophthalmic Solution 0.1%
CSB-001: human recombinant dHGF (5-amino acid deleted hepatocyte growth factor)
Locations (6)
Loma Linda University Eye Institute
Loma Linda, California, United States
Midwest Cornea Associates, LLC
Carmel, Indiana, United States
Francis Price Jr, MD
Indianapolis, Indiana, United States
Minnesota Eye Consultants
Minnetonka, Minnesota, United States
Legacy Devers Eye Institute
Portland, Oregon, United States
Stuart A. Terry, MD PA
San Antonio, Texas, United States