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

Phase 4

Recruiting

• Conditions: Cataract
• Interventions: Drug: Dexamethasone; Drug: Prednisolone Acetate Ophthalmic

• Registration Number: NCT05191706
• Lead Sponsor: EyePoint Pharmaceuticals, Inc.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-13
• Study First Submitted QC: 2022-01-03
• Study Start: 2022-01-04
• Study First Posted: 2022-01-13
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-27
• Primary Completion: 2025-01
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DEXYCU (dexamethasoneintraocular suspension) 9%	Dexamethasone	A single 0.005-mL anterior chamber injection of DEXYCU (dexamethasoneintraocular suspension) 9%, equivalent to 517mcg dexamethasone.
Prednisolone acetate ophthalmic suspension (USP) 1%	Prednisolone Acetate Ophthalmic	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.

Primary Outcome Measures

Name	Time	Method
Grade of anterior chamber cells (ACC)	Post-Operative Day 14

Secondary Outcome Measures

Name	Time	Method
Grade of anterior chamber flare (ACF)	Post-Operative Day 14

Trial Locations

Locations (2)

EyePoint Investigative Site; 🇺🇸 New York, New York, United States

EyePoint Investigational Site; 🇺🇸 Charleston, South Carolina, United States