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NCT05550363 | Withdrawn | Cataract

A Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery (2)
Sponsor:

EyePoint Pharmaceuticals, Inc.

Brief Summary:

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

Condition or disease

Cataract

Intervention/treatment

Dex a cluster

Placebo/Vehicle

Phase

Phase 3

Study Type : Interventional
Estimated Enrollment : 0 participants
Masking : Triple
Masking Description : Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose : Treatment
Official Title : 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
Actual Study Start Date : September 2022
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023
Arm Intervention/treatment

Experimental: D

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

Drug: Dexycu

Placebo Comparator: Placebo

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

Other: Placebo/Vehicle
Ages Eligible for Study: 40 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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.
A Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery (2)

Location Details

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A Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery (2)

How to Participate

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