Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Corneal Scars
Claris Biotherapeutics, Inc. · NCT06257355
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–80 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 1
- Target enrollment
- 20
- US sites recruiting
- 7
- Study start
- February 5, 2024
- Record last updated
- April 7, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study 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.
Being studied: CSB-001 Ophthalmic Solution 0.1%
Conditions: Corneal Scar
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- Centrally or paracentrally located scar approximately ≤5 mm and ≥2 mm in the greatest diameter and with a portion of the scar within approximately 3.5 mm of the optical center of the cornea assessed at Screening and confirmed at Baseline, and subject reports ability to detect any effect of scar on any element of vision.
- Eye with a recent corneal insult approximately ≤30 days and ≥7 days from the Screening Visit.
- Corneal insult includes but is not limited to mechanical / chemical / thermal injury, bacterial keratitis, PRK, and contact lens related ulcer.
- Eye with observed rate of epithelialization that in the investigator's opinion does not demonstrate clinical characteristics of a slow healing (persistent defect) cornea.
- Subjects must have the ability and willingness to comply with study procedures.
Exclusion Criteria
- Corneal scar that encompasses more than approximately 50% of the depth of the remaining stroma as guided by ASOCT image at the Screening Visit.
- Maximum scar diameter greater than approximately 5 mm without prior approval by the Sponsor based on Screening Visit images.
- No portion of the scar is within the approximate 3.5 mm of the optical center of the cornea based on Screening Visit images.
- Any active ocular infection in the opinion of the investigator (bacterial, viral, fungal, or protozoal) at the Screening or Day 1 Visits. Subjects with an active bacterial infection at the Screening or Day 1 Visit in the opinion of the investigator may be rescheduled to reassess the status of the infection and continue in the study if infection is deemed not active.
- Ocular surgery planned during the study treatment period.
- Presence or history of any ocular or systemic disorder, condition or procedure that might hinder the efficacy of the study treatment or its evaluation, could possibly interfere with the interpretation of study results, or could be judged by the investigator to be incompatible with the study visit schedule or conduct.
Note: Other inclusion/exclusion criteria apply.
Recruiting US locations
Loma Linda University Eye Institute
Loma Linda, CA 92354
Site contact: Study Coordinator
Midwest Cornea Associates, LLC
Carmel, IN 46290
Site contact: Study Coordinator
Francis Price Jr, MD
Indianapolis, IN 46260
Site contact: Study Coordinator
Minnesota Eye Consultants
Minnetonka, MN 55305
Site contact: Study Coordinator
Legacy Devers Eye Institute
Portland, OR 97210
Site contact: Study Coordinator
Stuart A. Terry, MD PA
San Antonio, TX 78212
Site contact: Study Coordinator
Virginia Eye Consultants
Norfolk, VA 23502
Site contact: Study Coordinator
Study contacts (from the official record)
- Central Operations Representative · 949-354-1299 · clinicaltrials@clarisbio.com
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