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

EyePoint Pharmaceuticals

Status and phase: Enrolling; Phase 4

Conditions: Cataract

Treatments: Drug: Dexamethasone; Drug: Prednisolone Acetate Ophthalmic

Study type: Interventional

Funder types: Industry

Identifiers

NCT05191706

EYP-DIP-001

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: Under 3 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

DEXYCU (dexamethasoneintraocular suspension) 9%

Experimental group

Description:

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

Treatment:

Drug: Dexamethasone

Prednisolone acetate ophthalmic suspension (USP) 1%

Active Comparator group

Description:

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.

Treatment:

Drug: Prednisolone Acetate Ophthalmic