A Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery

EyePoint Pharmaceuticals, Inc.

Overview

A Phase 3, Prospective, Randomized, Double-masked, Placebo-controlled, Parallel-design, Multicenter Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated with Cataract Surgery

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Conditions

Cataract

Interventions

DexycuDRUG

103.4 mcg/mcl dexamethasone: equivalent dexamethasone dose: 517 mcg

Placebo/VehicleOTHER

Placebo/vehicle, 0 mcg/mcl dexamethasone: equivalent dexamethasone dose: 0 mcg

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female subjects at least 40 years of age scheduled for cataract surgery * Best corrected visual acuity (BCVA) of 20/30-20/200 in the study eye * Must be considered by the investigator to have visual (VA) acuity potential greater than 20/30 in the study eye. Exclusion Criteria: * Use of any corticosteroids within 7 days prior to Day 0 * Injection of any corticosteroids, systemic immunomodulators or alkylating agents into any body tissue within 90 days * Score greater than "0" on the Ocular Pain Assessment in the study eye at Screening.

Outcomes

Primary Outcomes

Proportion of subjects with absence of ocular pain (ie, score of '0') in the study eye at Day 8

Time frame: Day 8

Secondary Outcomes

Proportion of subjects with absence of ocular pain in the study eye at Days 1, 3, 15, and 30

Time frame: Days 1, 3, 15, and 30

Mean ocular pain scores in the study eye

Numerical Ocular Pain Scale from 0-10 with 0 being no pain and 10 being most severe