Actively Recruiting
Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Corneal Scars
Led by Claris Biotherapeutics, Inc. · Updated on 2026-04-07
20
Participants Needed
7
Research Sites
177 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Corneal Scars
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Centrally or paracentrally located corneal scar about 2 to 5 mm in size with part of the scar within about 3.5 mm of the cornea's center
- Corneal scar formed from a recent eye injury or infection within 7 to 30 days before screening
- Corneal injuries include mechanical, chemical, thermal damage, bacterial keratitis, PRK, or contact lens ulcers
- Eye shows normal healing without signs of slow recovery
- Ability and willingness to follow all study procedures
You will not qualify if you...
- Corneal scar involving more than about 50% depth of the cornea's remaining stromal layer
- Scar diameter larger than about 5 mm without sponsor approval
- No part of the scar is within about 3.5 mm of the cornea's center
- Active eye infections like bacterial, viral, fungal, or protozoal infections at screening or Day 1
- Planned eye surgery during the treatment period
- Any eye or systemic condition that might interfere with treatment effect or study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Loma Linda University Eye Institute
Loma Linda, California, United States, 92354
Actively Recruiting
2
Midwest Cornea Associates, LLC
Carmel, Indiana, United States, 46290
Actively Recruiting
3
Francis Price Jr, MD
Indianapolis, Indiana, United States, 46260
Actively Recruiting
4
Minnesota Eye Consultants
Minnetonka, Minnesota, United States, 55305
Actively Recruiting
5
Legacy Devers Eye Institute
Portland, Oregon, United States, 97210
Actively Recruiting
6
Stuart A. Terry, MD PA
San Antonio, Texas, United States, 78212
Actively Recruiting
7
Virginia Eye Consultants
Norfolk, Virginia, United States, 23502
Actively Recruiting
Research Team
C
Central Operations Representative
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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