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Recruiting NCT05191706

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

Phase IV Interventional Cataract

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dexamethasone, Prednisolone Acetate Ophthalmic.
Who it may be relevant to
Registry conditions: Cataract. Basic parameters: up to 3 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

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

Primary outcome measures

  • Grade of anterior chamber cells (ACC) [Time frame: Post-Operative Day 14]
Secondary outcome measures (1)
  • Grade of anterior chamber flare (ACF) [Time frame: Post-Operative Day 14]

Eligibility criteria

Inclusion criteria

  • Undergoing uncomplicated cataract surgery with or without a posterior chamber intraocular lens (IOL) implantation.
  • If a contact lens is used for correction of post-operative aphakia, it must be a silicone elastomer lens or a rigid gas permeable lens (no water content).
  • Other protocol-specified inclusion criteria may apply.

Exclusion criteria

  • Presence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, endocrine, neurological, psychiatric, respiratory, or other medical condition that could increase the risk to the subject as determined by the investigator.
  • Has a post-traumatic cataract.
  • Presence of active or suspected viral, bacterial, or fungal disease in the study eye.
  • Ocular hypertension with an IOP in the study eye >25 mmHg at Screening with or without treatment with anti-glaucoma monotherapy.
  • Subjects who have received a periocular corticosteroid injection in the study eye in the 3 months prior to Screening.
  • Subjects who have received any intravitreal corticosteroid delivery vehicle (eg, Retisert®, Ozurdex®, Iluvien®) in the study eye at any time.
  • Other protocol-specified exclusion criteria may apply

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 9 centers
  • EyePoint Investigational Site — Huntington Beach
  • EyePoint Investigational Site — Palo Alto
  • EyePoint Investigative Site — Boston
  • EyePoint Investigational Site — Jackson
  • EyePoint Investigational Site — Omaha
  • EyePoint Investigational Site — Buffalo
  • EyePoint Investigative Site — New York
  • EyePoint Investigational Site — Rochester
  • … and 1 more center

Identifiers

NCT: NCT05191706 · EYP-DIP-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗