Phase 3, Multicenter, Randomized, Double-Masked, Vehicle-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Recombinant Human Nerve Growth Factor Eye Drop Solution in Participants With Persistent Corneal Epithelial Defect (PCED)

Summary

This is a phase 3, randomized, multicenter, double-masked, parallel group, vehicle-controlled prospective clinical trial to evaluate the safety and efficacy of cenegermin in inducing complete epithelial healing in participants with PCED. The primary objective is the evaluation of complete epithelial healing after 4 weeks of treatment. The study is comprised of 3 periods: an 8-week initial treatment period (Day 1 to Week 8), an 8-week extension treatment period (Week 9 to Week 16), and a 24-week follow-up period (Week 17 to Week 40).

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No