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)
Dompé Farmaceutici S.p.A
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
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…
Interventions
- DrugCenegermin
Cenegermin is administered topically.
- OtherVehicle
Vehicle is administered topically.
Locations (77)
- Azul Vision, INCHuntington Beach, California
- Harvard Eye AssociatesLaguna Hills, California
- Loma Linda University Adventist Health Sciences CenterLoma Linda, California
- UCLA - Jules Stein Eye Institute (JSEI) - Diabetic Eye DiseLos Angeles, California
- California Eye Specialists Medical Group, Inc.Redlands, California
- East Coast Institute for Research - Florida Eye SpecialistsJacksonville, Florida