NCT07519902

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

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)

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Dompé Farmaceutici S.p.A · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Persistent Corneal Epithelial Defect

Interventions

Type	Name	Description
DRUG	Cenegermin	Cenegermin is administered topically.
OTHER	Vehicle	Vehicle is administered topically.

Timeline

• Start date: 2026-04-30
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2026-04-09
• Last updated: 2026-04-09

Regulatory

• FDA-regulated drug study