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RECRUITING
NCT06452316
PHASE1

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.

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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