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

Sponsor

EyePoint Pharmaceuticals, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05191706

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Cataract	Drug: Dexamethasone Drug: Prednisolone Acetate Ophthalmic	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective, Randomized, Active Treatment-Controlled, Parallel-Design, Multicenter StudyProspective, Randomized, Active Treatment-Controlled, Parallel-Design, Multicenter Study

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DEXYCU (dexamethasoneintraocular suspension) 9% A single 0.005-mL anterior chamber injection of DEXYCU (dexamethasoneintraocular suspension) 9%, equivalent to 517mcg dexamethasone.	Drug: Dexamethasone single anterior chamber injection
Active Comparator: Prednisolone acetate ophthalmic suspension (USP) 1% 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 topical administration four times a day for 28 days, followed by treatment taper

Arm

Intervention/Treatment

Experimental: DEXYCU (dexamethasoneintraocular suspension) 9%

A single 0.005-mL anterior chamber injection of DEXYCU (dexamethasoneintraocular suspension) 9%, equivalent to 517mcg dexamethasone.

Drug: Dexamethasone

single anterior chamber injection

Active Comparator: Prednisolone acetate ophthalmic suspension (USP) 1%

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

topical administration four times a day for 28 days, followed by treatment taper

Outcome Measures

Primary Outcome Measures

Grade of anterior chamber cells (ACC) [Post-Operative Day 14]

Secondary Outcome Measures

Grade of anterior chamber flare (ACF) [Post-Operative Day 14]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 3 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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