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

September 21, 2022 updated by: EyePoint Pharmaceuticals, Inc.

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DEXYCU
DEXYCU, 103.4 mcg/mcl dexamethasone: equivalent dexamethasone dose: 517 mcg
Drug: Dexycu
103.4 mcg/mcl dexamethasone: equivalent dexamethasone dose: 517 mcg
Placebo Comparator: Placebo
Placebo/vehicle, 0 mcg/mcl dexamethasone: equivalent dexamethasone dose: 0 mcg
Other: Placebo/Vehicle
Placebo/vehicle, 0 mcg/mcl dexamethasone: equivalent dexamethasone dose: 0 mcg

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EyePoint Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2023

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

April 1, 2024

Study Registration Dates

First Submitted

September 16, 2022

First Submitted That Met QC Criteria

September 21, 2022

First Posted (Actual)

September 22, 2022

Study Record Updates

Last Update Posted (Actual)

September 22, 2022

Last Update Submitted That Met QC Criteria

September 21, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EYP-DIP-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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