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Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Corneal Scars

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Dec 31, 2025 to Jun 30, 2027
    • Study completion date: Jan 31, 2026 to Jun 30, 2027
    v10
  2. Primary completion date: May 31, 2025 to Dec 31, 2025
    • Study completion date: Aug 31, 2025 to Jan 31, 2026
    v9
  3. Study sites: 4 to 7v8
  4. Primary completion date: Dec 31, 2024 to May 31, 2025
    • Study completion date: Feb 28, 2025 to Aug 31, 2025
    v7
  5. Study arms: 1 to 2v6
Show 4 earlier versionsHide 4 earlier versions
  1. Re-verified, no change to tracked fieldsv5
  2. Study sites: 3 to 4v4
  3. Study sites: 2 to 3v3
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 recently formed corneal scars that resulted from a corneal insult presenting and diagnosed within the past approximately 30 days and not less than approximately 7 days. All subjects will be assigned to CSB-001 investigational treatment on Day 1. All subjects will dose with CSB-001 four times daily or three times daily starting on Day 1 and continue until Day 14. Subjects with a resolved scar at Day 7 will discontinue dosing and return to the clinic on Day 14. Subjects will return on Days 21, 28, 56, and Month 3 for safety and efficacy assessments.
Trial Details
NCT Number NCT06257355
Lead Sponsor Claris Biotherapeutics, Inc.
Conditions
(from sponsor)		 Corneal Scar
Related terms Corneal Injuries
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov