An Open-Label Study Evaluating the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Limbal Stem Cell Deficiency

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).

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * Have an area of the central 5 mm zone of cornea affected, presence of 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 dosing with Acthar at time of Screening Visit, must have a history of stable dosing for approximately 8 weeks, plan to maintain the same Acthar treatment dose and regimen, and have demonstrated little to no improvement in severity of LSCD. * Sponsor written confirmation of qualifying LSCD diagnosis. * Inflamm…

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
Midwest Cornea Associates, LLC
Carmel, Indiana
Francis Price Jr, MD
Indianapolis, Indiana
Minnesota Eye Consultants
Minnetonka, Minnesota
Legacy Devers Eye Institute
Portland, Oregon
Stuart A. Terry, MD PA
San Antonio, Texas