NCT05191706PHASE4Recruiting
Evaluate the Safety of DEXYCU for the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract
EyePoint Pharmaceuticals, Inc.
Start Date
1/4/2022
Completion Date
2/1/2026
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 Criteria
Age Range: No minimum to 3 years
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 determined by the investigator.
* Has a post-traumatic cataract.
* Presence of active or suspected viral, bacterial, or fungal disease in the study eye.
* Ocular hypertension with an IOP in the study eye \>25 mmHg at Screening with or without treatment with anti-glaucoma monotherapy.
* Subjects who have received a periocular corticosteroid injection in the study eye in the 3 months prior to Screening.
* Subjects who have received any intravitreal corticosteroid delivery vehicle (eg, Retisert®, Ozurdex®, Iluvien®) in the study eye at any time.
* Other protocol-specified exclusion criteria may apply
Interventions
DRUG
Dexamethasone
DRUG
Prednisolone Acetate Ophthalmic
Conditions
Cataract
Locations
EyePoint Investigational Site
Huntington Beach, California 92647
United States
EyePoint Investigational Site
Palo Alto, California 94303
United States
EyePoint Investigative Site
Boston, Massachusetts 02118
United States
EyePoint Investigational Site
Jackson, Mississippi 39216
United States
EyePoint Investigational Site
Omaha, Nebraska 68114
United States
EyePoint Investigational Site
Buffalo, New York 14209
United States
EyePoint Investigative Site
New York, New York 10032
United States
EyePoint Investigational Site
Rochester, New York 14642
United States
EyePoint Investigational Site
Charleston, South Carolina 29425
United States