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

Study Overview

• Status: Recruiting
• Conditions: Corneal Scar
• Intervention / Treatment: Biological: CSB-001 Ophthalmic Solution 0.1%

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Central Operations Representative; Phone Number: 949-354-1299; Email: clinicaltrials@clarisbio.com

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Recruiting
      • Loma Linda University Eye Institute
      • Contact: Study Coordinator
  • Indiana
    • Carmel, Indiana, United States, 46290
      • Recruiting
      • Midwest Cornea Associates, LLC
      • Contact: Study Coordinator
    • Indianapolis, Indiana, United States, 46260
      • Recruiting
      • Francis Price Jr, MD
      • Contact: Study Coordinator
  • Minnesota
    • Minnetonka, Minnesota, United States, 55305
      • Recruiting
      • Minnesota Eye Consultants
      • Contact: Study Coordinator
  • Oregon
    • Portland, Oregon, United States, 97210
      • Recruiting
      • Legacy Devers Eye Institute
      • Contact: Study Coordinator
  • Texas
    • San Antonio, Texas, United States, 78212
      • Recruiting
      • Stuart A. Terry, MD PA
      • Contact: Study Coordinator
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Recruiting
      • Virginia Eye Consultants
      • Contact: Study Coordinator

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety as Assessed by Adverse Event Reporting	Incidence of ocular and systemic adverse events	Day 1 through Day 56
Safety as Assessed by Slit-lamp Biomicroscopy	Change from baseline in staining using NEI scale (0 = absent to 3 = severe for 5 areas of the cornea) with Grade 0 (no staining) to maximum of Grade 15	Screening through Day 56
Safety as Assessed by Best-Corrected Distance Visual Acuity	Change from baseline using the Early Treatment Diabetic Retinopathy Study (EDTRS) visual acuity chart	Screening through Day 56

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy as Assessed by Area of Corneal Scar	Area of corneal scar as measured by slit lamp and anterior segment optical coherence tomography (AS-OCT) imaging	Screening through Day 56
Efficacy as Assessed by Maximum Depth of Cornea Scar	Depth measured with AS-OCT imaging	Screening through Day 56
Efficacy as Assessed by Volume of Scar	Volume measured with AS-OCT imaging	Screening through Day 56
Efficacy as Assessed by Density of Scar	Density based on AS-OCT and Pentacam imaging	Screening through Day 56
Efficacy as Assessed by Contrast Sensitivity	Contrast sensitivity measured using Pelli-Robson chart	Screening through Day 56
Efficacy as Assessed by Distance Visual Acuity	Visual acuity measured using the EDTRS visual acuity chart	Screening through Day 56

Collaborators and Investigators

• Sponsor: Claris Biotherapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: February 6, 2024
• First Submitted That Met QC Criteria: February 6, 2024
• First Posted (Actual): February 13, 2024

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Eye Diseases; Corneal Diseases; Craniocerebral Trauma; Trauma, Nervous System; Eye Injuries; Facial Injuries; Corneal Injuries; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: CSB-C23-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No