Evaluate the Safety of DEXYCU for the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract

Study Overview
=================
Brief 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

Official Title
-----------------
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

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Drug: Dexamethasone
* Drug: Prednisolone Acetate Ophthalmic


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Maximum Age: 3 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, Randomized, Active Treatment-Controlled, Parallel-Design, Multicenter Study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DEXYCU (dexamethasoneintraocular suspension) 9%<br>A single 0.005-mL anterior chamber injection of DEXYCU (dexamethasoneintraocular suspension) 9%, equivalent to 517mcg dexamethasone. | Drug: Dexamethasone<br>* single anterior chamber injection<br>|
| Active Comparator: Prednisolone acetate ophthalmic suspension (USP) 1%<br>Active treatment control, prednisolone acetate ophthalmic suspension (USP) 1%, four times daily (QID) for 28days, followed by a treatment taper at the investigator's discretion. | Drug: Prednisolone Acetate Ophthalmic<br>* topical administration four times a day for 28 days, followed by treatment taper<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grade of anterior chamber cells (ACC) |  | Post-Operative Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grade of anterior chamber flare (ACF) |  | Post-Operative Day 14 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pediatric, cataract