At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating CSB-001 Ophthalmic Solution 0.1% and Vehicle Control for Neurotrophic Keratitis. Completed, enrolled 131 participants across 48 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
CSB-001: human recombinant dHGF (5-amino acid deleted hepatocyte growth factor)
Matching vehicle control without the drug substance