Evaluating a new eye treatment for corneal scars

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Central Operations Representative
• Email: clinicaltrials@clarisbio.com
• Phone: 949-354-1299

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.