Evaluating a new eye treatment for corneal scars

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

This study is testing a new eye treatment called CSB-001 to see if it can help people with recent corneal scars improve their vision.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Claris Biotherapeutics, Inc. (Industry-sponsored)
• Locations: 7 sites (Loma Linda, California and 6 other locations)
• Trial ID: NCT06257355 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of CSB-001, an ophthalmic solution, in patients with recently formed corneal scars. Participants will receive the treatment four or three times daily for 14 days, depending on their dosing schedule. The study will monitor the resolution of the scar and assess safety and efficacy through follow-up visits at specified intervals. The goal is to determine if CSB-001 can effectively improve vision by treating corneal scars resulting from various insults.

Who should consider this trial

Good fit: Ideal candidates are individuals with centrally or paracentrally located corneal scars that are between 2 mm and 5 mm in diameter and have occurred within the last 7 to 30 days.

Not a fit: Patients with corneal scars that are too deep or those whose scars encompass more than 50% of the remaining stroma may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could significantly improve vision for patients suffering from corneal scars.

How similar studies have performed: While this approach is novel for treating corneal scars, similar interventions in ocular treatments have shown promising results in other contexts.

Eligibility 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.

Where this trial is running

Loma Linda, California and 6 other locations

• Loma Linda University Eye Institute — Loma Linda, California, United States (Recruiting)
• Midwest Cornea Associates, LLC — Carmel, Indiana, United States (Recruiting)
• Francis Price Jr, MD — Indianapolis, Indiana, United States (Recruiting)
• Minnesota Eye Consultants — Minnetonka, Minnesota, United States (Recruiting)
• Legacy Devers Eye Institute — Portland, Oregon, United States (Recruiting)
• Stuart A. Terry, MD PA — San Antonio, Texas, United States (Recruiting)
• Virginia Eye Consultants — Norfolk, Virginia, United States (Recruiting)

Study contacts

• Study coordinator: Central Operations Representative

Conditions Corneal Scar