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

Corneal Scar Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06257355
• Other study ID #: CSB-C23-002
• Status: Recruiting
• Phase: Phase 1
• Start date: February 5, 2024
• Est. completion date: February 28, 2025

Study information

• Verified date: June 2024
• Source: Claris Biotherapeutics, Inc.
• Contact: Central Operations Representative
• Phone: 949-354-1299
• Email: clinicaltrials[@]clarisbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 28, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Corneal Injuries
• Corneal Scar

Intervention

Biological:
• CSB-001 Ophthalmic Solution 0.1%
CSB-001: human recombinant dHGF (5-amino acid deleted hepatocyte growth factor)

Locations

Country	Name	City	State
United States	Midwest Cornea Associates, LLC	Carmel	Indiana
United States	Virginia Eye Consultants	Norfolk	Virginia
United States	Legacy Devers Eye Institute	Portland	Oregon
United States	Stuart A. Terry, MD PA	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Claris Biotherapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety as Assessed by Adverse Event Reporting	Incidence of ocular and systemic adverse events	Day 1 through Day 56
Primary	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
Primary	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	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
Secondary	Efficacy as Assessed by Maximum Depth of Cornea Scar	Depth measured with AS-OCT imaging	Screening through Day 56
Secondary	Efficacy as Assessed by Volume of Scar	Volume measured with AS-OCT imaging	Screening through Day 56
Secondary	Efficacy as Assessed by Density of Scar	Density based on AS-OCT and Pentacam imaging	Screening through Day 56
Secondary	Efficacy as Assessed by Contrast Sensitivity	Contrast sensitivity measured using Pelli-Robson chart	Screening through Day 56
Secondary	Efficacy as Assessed by Distance Visual Acuity	Visual acuity measured using the EDTRS visual acuity chart	Screening through Day 56