NCT04909450

Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Neurotrophic Keratitis Subjects

A Multi-Center, Randomized, Double-Masked, Vehicle-Controlled, Parallel-Group, Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Stage 2 and 3 Neurotrophic Keratitis Subjects

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: Claris Biotherapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will enroll subjects with stage 2 or 3 neurotrophic keratitis. Subjects will be randomized in a 1:1 ratio to the CSB-001 investigational treatment arm or vehicle control arm. All subjects will dose with the randomized treatment four times daily for 8 weeks (controlled treatment phase). During the controlled treatment phase, subjects will return to the clinic weekly from Day 0 to Week 8, and again at Week 10. Subjects randomized to the vehicle arm who are not healed will have the opportunity to participate in an open-label uncontrolled treatment phase.

Conditions

• Neurotrophic Keratitis

Interventions

Type	Name	Description
BIOLOGICAL	CSB-001 Ophthalmic Solution 0.1%	CSB-001: human recombinant dHGF (5-amino acid deleted hepatocyte growth factor)
BIOLOGICAL	Vehicle Control	Matching vehicle control without the drug substance

Timeline

• Start date: 2021-08-24
• Primary completion: 2024-05-07
• Completion: 2024-06-04
• First posted: 2021-06-01
• Last updated: 2024-09-19

Locations

48 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study