Open for Enrollment Soon
This study will open for enrollment soon. Please contact the study team for more information and check back frequently.

NGF-PCED-301 - Clinical Trial

What is the Purpose of this Study?

In this study, participants will use eye drops in one eye six times each day for eight weeks. The eye drops will contain either the study medicine called cenegermin or a liquid with no medicine. Participants will write down each time they use the eye drops in a study diary. After the first eight weeks, the doctor will decide which group each person will be in for the next part of the study. During this next period, participants will continue using eye drops for another eight weeks. After that, they will use standard eye drops without preservatives for twenty four weeks.

What is the Condition Being Studied?

Persistent Corneal Epithelial Defect (PCED) of at least 14 days duration

Who Can Participate in the Study?

People can join this study if they are 18 years old or older and have a problem with the surface of the eye called a persistent corneal epithelial defect. The sore area on the eye must be at least 1 millimeter in size and must have been present for at least 14 days. The problem must not have improved even after trying one or more standard treatments that do not involve surgery.

What is Involved?

The purpose of this study is to see if an eye medicine called cenegermin works better than a liquid with no medicine to help heal damage on the surface of the eye. Researchers want to find out if the medicine can fully heal the eye after four weeks of treatment.

Study Details

Full Title
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)
Principal Investigator
Esen K. Akpek, MD
Ocular Immunologist
Protocol Number
IRB: PRO00120543
NCT: NCT07519902
Phase
Phase III
ClinicalTrials.gov
Enrollment Status
Open for Enrollment Soon
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