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

NCT ID: NCT05550350

Last Updated: 2025-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-30

Study Completion Date

2023-09-30

Brief Summary

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

Detailed Description

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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

Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, Randomized, Double-masked, Placebo-controlled,Parallel-design, Multicenter Study
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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DEXYCU

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

Group Type EXPERIMENTAL

Dexycu

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo/Vehicle

Intervention Type OTHER

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

Interventions

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Dexycu

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

Intervention Type DRUG

Placebo/Vehicle

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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EyePoint Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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EYP-DIP-301

Identifier Type: -

Identifier Source: org_study_id

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