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

Status Recruiting

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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Corneal Injuries
• Corneal Scar

• NCT number: NCT06257355
• Study type: Interventional
• Source: Claris Biotherapeutics, Inc.
• Contact: Central Operations Representative
• Phone: 919-205-0012
• Email: clinicaltrials@clarisbio.com
• Status: Recruiting
• Phase: Phase 1
• Start date: February 5, 2024
• Completion date: February 28, 2025