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

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ClinicalTrials.gov Identifier: NCT05191706
Recruitment Status : Recruiting
First Posted : January 13, 2022
Last Update Posted : January 13, 2022
Sponsor:
Information provided by (Responsible Party):
EyePoint Pharmaceuticals, Inc.

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 disease Intervention/treatment Phase
Cataract Drug: Dexamethasone Drug: Prednisolone Acetate Ophthalmic Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, 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
Estimated Study Start Date : January 2022
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : February 2024


Arm Intervention/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




Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05191706


Contacts
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Contact: Dario Paggiarino, MD 617-610-3411 dpaggiarino@eyepointpharma.com

Locations
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United States, California
EyePoint Investigational Site Not yet recruiting
Palo Alto, California, United States, 94303
Contact: Study Coordinator         
Principal Investigator: EyePoint Study Investigator         
United States, South Carolina
EyePoint Investigational Site Recruiting
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
EyePoint Pharmaceuticals, Inc.
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Responsible Party: EyePoint Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT05191706    
Other Study ID Numbers: EYP-DIP-001
First Posted: January 13, 2022    Key Record Dates
Last Update Posted: January 13, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by EyePoint Pharmaceuticals, Inc.:
pediatric
cataract
Additional relevant MeSH terms:
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Cataract
Inflammation
Pathologic Processes
Lens Diseases
Eye Diseases
Dexamethasone
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Neuroprotective Agents
Protective Agents