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

Sponsor
EyePoint Pharmaceuticals, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05191706
Collaborator
(none)
60
Enrollment
2
Locations
2
Arms
25
Anticipated Duration (Months)
30
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or DiseaseIntervention/TreatmentPhase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective, Randomized, Active Treatment-Controlled, Parallel-Design, Multicenter StudyProspective, Randomized, Active Treatment-Controlled, Parallel-Design, Multicenter Study
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

ArmIntervention/Treatment
Experimental: DEXYCU (dexamethasoneintraocular suspension) 9%

A single 0.005-mL anterior chamber injection of DEXYCU (dexamethasoneintraocular suspension) 9%, equivalent to 517mcg dexamethasone.

Drug: Dexamethasone
single anterior chamber injection

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.

Drug: Prednisolone Acetate Ophthalmic
topical administration four times a day for 28 days, followed by treatment taper

Outcome Measures

Primary Outcome Measures

  1. Grade of anterior chamber cells (ACC) [Post-Operative Day 14]

Secondary Outcome Measures

  1. Grade of anterior chamber flare (ACF) [Post-Operative Day 14]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 3 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1EyePoint Investigational SitePalo AltoCaliforniaUnited States94303
2EyePoint Investigational SiteCharlestonSouth CarolinaUnited States29425

Sponsors and Collaborators

  • EyePoint Pharmaceuticals, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
EyePoint Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT05191706
Other Study ID Numbers:
  • EYP-DIP-001
First Posted:
Jan 13, 2022
Last Update Posted:
Jan 13, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by EyePoint Pharmaceuticals, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 13, 2022