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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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. 2 versions Re-verified since Aug 5, 2026, no change to tracked fieldsv11-v12
  2. Enrollment increased: 65 → 75 participants
    • Secondary endpoints: details revised at 2 of 2 entries
    v10
  3. Primary completion date: Nov 2025 to Dec 31, 2027
    • Study completion date: May 2026 to Dec 31, 2027
    v9
  4. Secondary endpoints: details revised at 2 of 2 entriesv8
  5. Primary completion date: Aug 2025 to Nov 2025
    • Study completion date: Aug 2025 to May 2026
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Enrollment target: 40 to 65v6
  2. Study sites: 3 to 6v5
  3. Enrollment target: 20 to 40
    • Study arms: 1 to 2
    v4
  4. Study sites: 2 to 3v3
  5. Study sites: 1 to 2v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06452316
Lead Sponsor Claris Biotherapeutics, Inc.
Conditions
(from sponsor)		 Limbal Stem Cell Deficiency
Related terms Limbal Stem Cell Deficiency
Enrollment 75 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov