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HIPAA Compliant
ISO 27001 Certified

Actively Recruiting

Phase 1
Age: 18Years - 80Years
All Genders
ID06257355

Study of CSB-001 Eye Drops to Treat Corneal Scars in Adults Aged 18 to 80

Led by Claris Biotherapeutics, Inc. · Updated on 2026-04-07

20

Participants Needed

7

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of an investigational eye drop called CSB-001 Ophthalmic Solution 0.1% in adults with recent corneal scars caused by various eye injuries or conditions that occurred within the past 7 to 30 days. This Phase 1 study focuses on scars located near the center of the cornea that affect vision, aiming to understand how well the treatment works and how safe it is for participants. All participants will receive CSB-001 starting on Day 1, dosing either four times daily or three times daily in the affected eye for up to 14 days. If a participants scar has resolved by Day 7, they will stop treatment but continue follow-up visits. Scheduled visits occur on Days 14, 21, 28, 56, and at Month 3 to monitor progress and safety. Participants will have safety assessments including eye exams with slit-lamp biomicroscopy and vision tests from screening through Day 56. Researchers will also measure scar size, depth, volume, density, contrast sensitivity, and distance vision to evaluate the treatments effects. The study includes careful monitoring for any side effects and lasts about three months for each participant.

CONDITIONS

Brief Title

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

Research Team

C

Central Operations Representative

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