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

NCT06257355 | Recruiting Phase 1 FDA Drug

• 1 other identifier: CSB-C23-002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Corneal Scar

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Efficacy as Assessed by Area of Corneal Scar

  Screening through Day 56

• Efficacy as Assessed by Maximum Depth of Cornea Scar

  Screening through Day 56

• Efficacy as Assessed by Volume of Scar

  Screening through Day 56

• Efficacy as Assessed by Density of Scar

  Screening through Day 56

• Efficacy as Assessed by Contrast Sensitivity

  Screening through Day 56

Study Arms (2)

CSB-001 QID

EXPERIMENTAL

One drop CSB-001 four times daily for 14 days in the study eye

Biological: CSB-001 Ophthalmic Solution 0.1%

CSB-001 TID

EXPERIMENTAL

One drop CSB-001 three times daily for 14 days in the study eye

Biological: CSB-001 Ophthalmic Solution 0.1%

Interventions

CSB-001 Ophthalmic Solution 0.1% BIOLOGICAL

CSB-001: human recombinant dHGF (5-amino acid deleted hepatocyte growth factor)

CSB-001 QID; CSB-001 TID

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Claris Biotherapeutics, Inc.: lead

Study Sites (7)

Loma Linda University Eye Institute

Loma Linda, California, 92354, United States

RECRUITING

Midwest Cornea Associates, LLC

Carmel, Indiana, 46290, United States

RECRUITING

Francis Price Jr, MD

Indianapolis, Indiana, 46260, United States

RECRUITING

Minnesota Eye Consultants

Minnetonka, Minnesota, 55305, United States

RECRUITING

Legacy Devers Eye Institute

Portland, Oregon, 97210, United States

RECRUITING

Stuart A. Terry, MD PA

San Antonio, Texas, 78212, United States

RECRUITING

Virginia Eye Consultants

Norfolk, Virginia, 23502, United States

RECRUITING

MeSH Terms

Conditions

Corneal Injuries

Condition Hierarchy (Ancestors)

Eye Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Corneal Diseases; Eye Diseases; Wounds and Injuries

Central Study Contacts

Central Operations Representative

CONTACT

949-354-1299; clinicaltrials@clarisbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 13, 2024
• Study Start: February 5, 2024
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)