A Phase 3/4, Prospective, Randomized, Active Treatment Controlled, Parallel-Design, Multicenter Study to Evaluate the Safety of DEXYCU for the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract

Date Added
September 28th, 2021
PRO Number
Pro00114633
Researcher
Marion Wilson

List of Studies


Keywords
Vision/ Eye
Summary

The purpose of this study is to test the safety of an investigational drug product, IBI-10090 (DEXYCU), in children to treat eye inflammation (redness) caused by cataract surgery. DEXYCU was approved by the FDA in February 2018 for use in adults, however; has not yet been approved for use in children. The active ingredient in DEXYCU is dexamethasone. Instead of being an eye drop containing dexamethasone, DEXYCU remains in the eye as a tiny droplet and slowly releases dexamethasone over a period of approximately two to three weeks. After that time the droplet is absorbed by the body. Subjects 0 to 3 years of age who are undergoing cataract surgery will be eligible for this study. The study starts at screening visit which is 3-29 days before surgery. Any study-related procedures will be performed only after obtaining informed consent. Child will be in the study for about 90 days after signing informed consent. Enrollment in this study requires a total of 8 visits. If child is eligible he/she will be randomly assigned (like the flip of a coin) to either study group DEXYCU or control group, prednisolone acetate. Child will have study visits 1 day following cataract surgery, and then at approximately 1 week, 2 weeks, 4 weeks, 6 weeks and 3 months after surgery. All visits are standard of care visits for all cataract surgery patients except 2 weeks and 6 weeks after surgery visits.

Institution
MUSC
Recruitment Contact
Carol Bradham
843-792-2338
bradhamc@muscs.edu



-- OR --