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.
Who Can Participate?
Eligibility
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.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Looking for Healthy Participants
No
What is Involved?
Description
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.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
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
Akpek
Protocol Number
PRO00120543
NCT ID
NCT07519902
Phase
III
Enrollment Status
Pending Open to Enrollment