clinical trial · NCT06452316
Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Limbal Stem Cell Deficiency
Claris Biotherapeutics, Inc.·phase1·recruiting·n = 65
Limbal Stem Cell DeficiencyCSB-001 Ophthalmic Solution 0.1%
brief 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).
started
May 15, 2024
primary completion
Dec 31, 2027
completion
Dec 31, 2027
last updated
Apr 7, 2026
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol