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

Purpose

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.

Condition

  • Corneal Scar

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
CSB-001 QID 		One drop CSB-001 four times daily for 14 days in the study eye
  • Biological: CSB-001 Ophthalmic Solution 0.1%
    CSB-001: human recombinant dHGF (5-amino acid deleted hepatocyte growth factor)
Experimental
CSB-001 TID 		One drop CSB-001 three times daily for 14 days in the study eye
  • Biological: CSB-001 Ophthalmic Solution 0.1%
    CSB-001: human recombinant dHGF (5-amino acid deleted hepatocyte growth factor)

Recruiting Locations

Loma Linda University Eye Institute
Loma Linda, California 92354
Contact:
Study Coordinator

Midwest Cornea Associates, LLC
Carmel, Indiana 46290
Contact:
Study Coordinator

Francis Price Jr, MD
Indianapolis, Indiana 46260
Contact:
Study Coordinator

Minnesota Eye Consultants
Minnetonka, Minnesota 55305
Contact:
Study Coordinator

Legacy Devers Eye Institute
Portland, Oregon 97210
Contact:
Study Coordinator

Stuart A. Terry, MD PA
San Antonio, Texas 78212
Contact:
Study Coordinator

Virginia Eye Consultants
Norfolk, Virginia 23502
Contact:
Study Coordinator

More Details

Status
Recruiting
Sponsor
Claris Biotherapeutics, Inc.

Study Contact

Central Operations Representative
949-354-1299
clinicaltrials@clarisbio.com