Current Clinical Study
CSB-001 is being evaluated in an open-label, clinical study assessing safety and efficacy in participants with limbal stem cell deficiency (LSCD). In this trial, all enrolled subjects receive CSB-001 ophthalmic solution in either one or both eyes. The study is designed with two identical dosing periods separated by a treatment-free interval, followed by an observational phase to monitor longer-term safety and clinical observations.
The dosing periods allow investigators to gather information on safety, tolerability, and treatment effects over time, while the observational phase supports continued monitoring after active dosing is completed. This study structure enables Claris to refine its understanding of CSB-001’s profile and inform the design of future registrational trials.
LSCD Randomized-Controlled Pivotal Trial Design
