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).
Men or women aged 18 years or above (in South Korea, 19 years or above).
PCED ≥ 1.0 mm in greatest diameter
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 eye, if the participant has been on a stable dose for at least 30 days and does not expect to have change in dosing regimen throughout the entire duration of the study. Please see
Use of prophylactic topical antibiotics up to 4 times per day in the study eye is permitted if the participant is already receiving them prior to enrollment.
Contralateral eye with vision of no light perception or anatomic absence of contralateral eye.
Bacterial, fungal, or protozoal infection at screening
Active infectious stromal infiltrates or edema at screening
Parallel
Cenegermin
DrugCenegermin is administered topically.
Vehicle
Other interventionVehicle is administered topically.
Proportion of responders achieving complete epithelial healing of the cornea at Week 4 and maintained at Week 8
Percentage change from baseline in maximum diameter of PCED at week 4
Percentage change from baseline in maximum diameter of PCED at week 8
Proportion of responders achieving complete epithelial healing of the cornea at Week 8 and maintained at Week 10
Linear change from baseline in maximum diameter of the PCED at week 4
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