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
EyePoint Pharmaceuticals, Inc.
Summary
A Phase 3/4, Prospective, Randomized, Active Treatment-Controlled, Parallel-Design, Multicenter Study to Evaluate the Safety of DEXYCUfor the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract
Eligibility
- Age range
- Up to 3 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Undergoing uncomplicated cataract surgery with or without a posterior chamber intraocular lens (IOL) implantation. * If a contact lens is used for correction of post-operative aphakia, it must be a silicone elastomer lens or a rigid gas permeable lens (no water content). * Other protocol-specified inclusion criteria may apply. Exclusion Criteria: * Presence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, endocrine, neurological, psychiatric, respiratory, or other medical condition that could increase the risk to the subject as…
Interventions
- DrugDexamethasone
single anterior chamber injection
- DrugPrednisolone Acetate Ophthalmic
topical administration four times a day for 28 days, followed by treatment taper
Locations (9)
- EyePoint Investigational SiteHuntington Beach, California
- EyePoint Investigational SitePalo Alto, California
- EyePoint Investigative SiteBoston, Massachusetts
- EyePoint Investigational SiteJackson, Mississippi
- EyePoint Investigational SiteOmaha, Nebraska
- EyePoint Investigational SiteBuffalo, New York