An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of 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).

Timeline

Start

2026-06-02

Primary completion

2027-12

Completion

2027-12

Drugs

Indications