Medical College of Wisconsin Ophthalmology and Visual Sciences Research Study - NEXAGON for Persistent Corneal Epithelial Defect (PCED)

Purpose of Study:

This project is being done to find out whether NEXAGON, an investigational topical gel for the eye, reduces the symptoms of Persistent Corneal Epithelial Defect (PCED), and whether it causes any problems (side effects). NEXAGON is still experimental and is not approved by the U.S. Food and Drug Administration.

What is Persistent Corneal Epithelial Defect (PCED)?

Persistent Corneal Epithelial Defect (PCED) is a condition that is caused by damage to the clear layer at the front of your eye (called the cornea). When the cornea is damaged, it normally heals within a few days to a couple weeks. When a cornea fails to heal within the normal time frame despite using the best available medicines and procedures, this is known as Persistent Corneal Epithelial Defect (PCED).

What is involved in this project?

This project will last for about 8-24 weeks, and participants will have study visits once each week. This study is divided into 2 different periods, a “Treatment Period” and an “Open Label Treatment Period.” During the Treatment Period, participants will be randomly assigned to receive NEXAGON vs. a placebo and will have a 50% chance of being assigned to NEXAGON over placebo. During the Open Label Period, all participants will receive NEXAGON. Participants will only be eligible to participate in the Open Label Treatment period if they do not respond to treatment during the Treatment Period or if their PCED has not healed or has reopened. Study visits may vary in length, but on average we anticipate they will take about 2-4 hours.