Recruiting
Phase 1

CSB-001

Sponsor:

Claris Biotherapeutics, Inc.

Code:

NCT06257355

Conditions

Corneal Scar

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

CSB-001 Ophthalmic Solution 0.1%

Study Details

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

Study ID

NCT06257355

Start date

Feb 5, 2024

Status verified date

Apr, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CSB-001 QID

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

experimental: CSB-001 TID

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

Interventions

CSB-001 Ophthalmic Solution 0.1%

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

Primary outcome measure

  • Safety as Assessed by Adverse Event Reporting [ Time Frame: Day 1 through Day 56 ]
  • Safety as Assessed by Slit-lamp Biomicroscopy [ Time Frame: Screening through Day 56 ]
  • Safety as Assessed by Best-Corrected Distance Visual Acuity [ Time Frame: Screening through Day 56 ]

Central Contacts and Locations

Central contacts

Central Operations Representative

949-354-1299clinicaltrials@clarisbio.com

Locations

Loma Linda University Eye Institute

Recruiting

Loma Linda, California, United States, 92354

Midwest Cornea Associates, LLC

Recruiting

Carmel, Indiana, United States, 46290

Francis Price Jr, MD

Recruiting

Indianapolis, Indiana, United States, 46260

Minnesota Eye Consultants

Recruiting

Minnetonka, Minnesota, United States, 55305

Legacy Devers Eye Institute

Recruiting

Portland, Oregon, United States, 97210

Stuart A. Terry, MD PA

Recruiting

San Antonio, Texas, United States, 78212

Virginia Eye Consultants

Recruiting

Norfolk, Virginia, United States, 23502

More Information

Sponsor

Claris Biotherapeutics, Inc.

Last update posted

Apr 7, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Claris Biotherapeutics, Inc. on 2026-04-07.