A STUDY TO EVALUATE THE SAFETY AND EFFICACY OF KPI-012 OPHTHALMIC SOLUTION IN PARTICIPANTS WITH PERSISTENT CORNEAL EPITHELIAL DEFECT (PCED)
Primary Objective
The primary objective of the study is to investigate the safety and efficacy of KPI-012 compared to vehicle in participants who have a documented clinical diagnosis of PCED
![](https://researchstudies.cuanschutz.edu/Content/images/study-category-images/eyes.jpg)
Description
PCED is a persistent non-healing corneal defect or wound that does not heal with traditional treatments. There are many causes of PCED including mechanical trauma, corneal dryness, neurotrophic disease, post-surgical changes, and infection. In patients with PCED, the corneal epithelium (outer most corneal layer) breaks down causing corneal wounds, ulcers, ocular damage, and scarring resulting in symptoms such as pain, tearing, foreign body sensation, redness, and blurry vision. The purpose of Cohort 2 of this study is to see if two doses (low and high) of the KPI-012 eye drops are safe and work to repair (heal) persistent corneal epithelial defects compared to the placebo eye drops. Cohort 1 of this study assessed if the KPI-012 High Dose was safe to include in Cohort 2 of this study.
Details
Locations
University of Colorado Hospital
Principal Investigator
![Photograph of Cecelia Koetting](https://researchstudies.cuanschutz.edu/Content/images/investigators/no-photo.jpg)
Cecelia Koetting
Study ID
Protocol Number: 24-0739
More information available at ClinicalTrials.gov: NCT05727878
Categories
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