NCT06257355

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Claris Biotherapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	CSB-001 Ophthalmic Solution 0.1%	CSB-001: human recombinant dHGF (5-amino acid deleted hepatocyte growth factor)

Timeline

• Start date: 2024-02-05
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2024-02-13
• Last updated: 2026-04-07

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study