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

Phase 3

Not yet recruiting

• Conditions: Cataract
• Interventions: Drug: Dexycu; Other: Placebo/Vehicle

• Registration Number: NCT05550350
• Lead Sponsor: EyePoint Pharmaceuticals, Inc.

Brief Summary

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

Detailed Description

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 Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-16
• Study First Submitted QC: 2022-09-21
• Last Update Submitted: 2022-09-21
• Study First Posted: 2022-09-22
• Last Update Posted: 2022-09-22
• Study Start: 2023-03
• Primary Completion: 2024-04
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DEXYCU	Dexycu	DEXYCU, 103.4 mcg/mcl dexamethasone: equivalent dexamethasone dose: 517 mcg
Placebo	Placebo/Vehicle	Placebo/vehicle, 0 mcg/mcl dexamethasone: equivalent dexamethasone dose: 0 mcg

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects with absence of ocular pain in the study eye at Days 1, 3, 15, and 30	Days 1, 3, 15, and 30
Rates of ocular (study eye and fellow eye) and non-ocular TEAEs	up to day 30
Mean ocular pain scores in the study eye	Days 1, 3, 8, 15 and 30	Numerical Ocular Pain Scale from 0-10 with 0 being no pain and 10 being most severe
Proportion of subjects with absence of cells in the AC of the study eye	Days 1, 3, 8, 15 and 30
Proportion of subjects with absence of flare in the AC of the study eye	Days 1, 3, 8, 15 and 30
Mean AC cell score in the study eye	Days 1, 3, 8, 15 and 30	AC count by Slit Lamp Biomicroscopy with 0 being none and 4 being most severe
Mean AC flare score in the study eye	Days 1, 3, 8, 15 and 30	AC count by Slit Lamp Biomicroscopy with 0 being absent and 4 being strong intensity