Evaluate the Safety of DEXYCU for the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract

Part of paid clinical trials in Huntington Beach, California.

Sponsor
EyePoint Pharmaceuticals, Inc.
Study ID
NCT05191706
Phase
PHASE4
Status
Recruiting
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Conditions

  • Cataract

Eligibility Criteria

Sex
ALL
Age
N/A - 3 Years
Healthy Volunteers
Not accepted

Interventions

  • Dexamethasone — DRUG
    single anterior chamber injection
  • Prednisolone Acetate Ophthalmic — DRUG
    topical administration four times a day for 28 days, followed by treatment taper

Study Details

A Phase 3/4, Prospective, Randomized, Active Treatment-Controlled, Parallel-Design, Multicenter Study to Evaluate the Safety of DEXYCUfor the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract

Key Dates

First listed
Jan 13, 2022
Start date
Jan 4, 2022
Status verified
Apr 2025
Primary completion
Jan 31, 2026
Completion
Feb 28, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: DEXYCU (dexamethasoneintraocular suspension) 9%
    A single 0.005-mL anterior chamber injection of DEXYCU (dexamethasoneintraocular suspension) 9%, equivalent to 517mcg dexamethasone.
  • Active Comparator: Prednisolone acetate ophthalmic suspension (USP) 1%
    Active treatment control, prednisolone acetate ophthalmic suspension (USP) 1%, four times daily (QID) for 28days, followed by a treatment taper at the investigator's discretion.

Primary Outcome Measure

Grade of anterior chamber cells (ACC) [ Time Frame: Post-Operative Day 14 ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
EyePoint Investigational SiteHuntington BeachCalifornia92647-
EyePoint Investigational SitePalo AltoCalifornia94303-
EyePoint Investigative SiteBostonMassachusetts02118-
EyePoint Investigational SiteJacksonMississippi39216-
EyePoint Investigational SiteOmahaNebraska68114-
EyePoint Investigational SiteBuffaloNew York14209-
EyePoint Investigative SiteNew YorkNew York10032-
EyePoint Investigational SiteRochesterNew York14642-
EyePoint Investigational SiteCharlestonSouth Carolina29425-

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