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

Last updated: May 15, 2025
Sponsor: Claris Biotherapeutics, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

CSB-001 Ophthalmic Solution 0.1%

Clinical Study ID

NCT06257355
CSB-C23-002
  • Ages 18-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Centrally or paracentrally located scar approximately ≤5 mm and ≥2 mm in thegreatest diameter and with a portion of the scar within approximately 3.5 mm of theoptical center of the cornea assessed at Screening and confirmed at Baseline, andsubject 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 theScreening Visit.

  • Corneal insult includes but is not limited to mechanical / chemical / thermalinjury, bacterial keratitis, PRK, and contact lens related ulcer.

  • Eye with observed rate of epithelialization that in the investigator's opinion doesnot demonstrate clinical characteristics of a slow healing (persistent defect)cornea.

  • Subjects must have the ability and willingness to comply with study procedures.

Exclusion

Exclusion Criteria:

  • Corneal scar that encompasses more than approximately 50% of the depth of theremaining stroma as guided by ASOCT image at the Screening Visit.

  • Maximum scar diameter greater than approximately 5 mm without prior approval by theSponsor based on Screening Visit images.

  • No portion of the scar is within the approximate 3.5 mm of the optical center of thecornea 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 activebacterial infection at the Screening or Day 1 Visit in the opinion of theinvestigator may be rescheduled to reassess the status of the infection and continuein 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 thatmight hinder the efficacy of the study treatment or its evaluation, could possiblyinterfere with the interpretation of study results, or could be judged by theinvestigator to be incompatible with the study visit schedule or conduct.

Note: Other inclusion/exclusion criteria apply.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: CSB-001 Ophthalmic Solution 0.1%
Phase: 1
Study Start date:
February 05, 2024
Estimated Completion Date:
August 31, 2025

Connect with a study center

  • Loma Linda University Eye Institute

    Loma Linda, California 92354
    United States

    Active - Recruiting

  • Midwest Cornea Associates, LLC

    Carmel, Indiana 46290
    United States

    Active - Recruiting

  • Francis Price Jr, MD

    Indianapolis, Indiana 46260
    United States

    Active - Recruiting

  • Minnesota Eye Consultants

    Minnetonka, Minnesota 55305
    United States

    Active - Recruiting

  • Legacy Devers Eye Institute

    Portland, Oregon 97210
    United States

    Active - Recruiting

  • Stuart A. Terry, MD PA

    San Antonio, Texas 78212
    United States

    Active - Recruiting

  • Virginia Eye Consultants

    Norfolk, Virginia 23502
    United States

    Active - Recruiting

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