Dompé Farmaceutici S.p.A
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).
Inclusion Criteria: * Men or women aged 18 years or above (in South Korea, 19 years or above). * Participants with PCED in the study eye with the following characteristics: 1. PCED ≥ 1.0 mm in greatest diameter 2. PCED of at least 14 days duration, refractory to 1 or more conventional nonsurgical treatments (ocular lubricants, discontinuation of preserved topical drops and medications, bandage contact lens) showing no clinical resolution. * Use of most topical ophthalmic medications (including glaucoma medications) indicated for ocular conditions other than PCED is permitted in the study…
Cenegermin is administered topically.
Vehicle is administered topically.