Evaluate the Safety of DEXYCU for the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract
Primary Purpose
Cataract
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone
Prednisolone Acetate Ophthalmic
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring pediatric, cataract
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
Sites / Locations
- EyePoint Investigational SiteRecruiting
- EyePoint Investigational SiteRecruiting
- EyePoint Investigative SiteRecruiting
- EyePoint Investigational SiteRecruiting
- EyePoint Investigational SiteRecruiting
- EyePoint Investigational SiteRecruiting
- EyePoint Investigative SiteRecruiting
- EyePoint Investigational SiteRecruiting
- EyePoint Investigational SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DEXYCU (dexamethasoneintraocular suspension) 9%
Prednisolone acetate ophthalmic suspension (USP) 1%
Arm Description
A single 0.005-mL anterior chamber injection of DEXYCU (dexamethasoneintraocular suspension) 9%, equivalent to 517mcg dexamethasone.
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.
Outcomes
Primary Outcome Measures
Grade of anterior chamber cells (ACC)
Secondary Outcome Measures
Grade of anterior chamber flare (ACF)
Full Information
NCT ID
NCT05191706
First Posted
December 13, 2021
Last Updated
February 13, 2023
Sponsor
EyePoint Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05191706
Brief Title
Evaluate the Safety of DEXYCU for the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 4, 2022 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EyePoint Pharmaceuticals, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
pediatric, cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Prospective, Randomized, Active Treatment-Controlled, Parallel-Design, Multicenter Study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DEXYCU (dexamethasoneintraocular suspension) 9%
Arm Type
Experimental
Arm Description
A single 0.005-mL anterior chamber injection of DEXYCU (dexamethasoneintraocular suspension) 9%, equivalent to 517mcg dexamethasone.
Arm Title
Prednisolone acetate ophthalmic suspension (USP) 1%
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
single anterior chamber injection
Intervention Type
Drug
Intervention Name(s)
Prednisolone Acetate Ophthalmic
Intervention Description
topical administration four times a day for 28 days, followed by treatment taper
Primary Outcome Measure Information:
Title
Grade of anterior chamber cells (ACC)
Time Frame
Post-Operative Day 14
Secondary Outcome Measure Information:
Title
Grade of anterior chamber flare (ACF)
Time Frame
Post-Operative Day 14
10. Eligibility
Sex
All
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dario Paggiarino, MD
Phone
617-610-3411
Email
dpaggiarino@eyepointpharma.com
Facility Information:
Facility Name
EyePoint Investigational Site
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Individual Site Status
Recruiting
Facility Name
EyePoint Investigational Site
City
Palo Alto
State/Province
California
ZIP/Postal Code
94303
Country
United States
Individual Site Status
Recruiting
Facility Name
EyePoint Investigative Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Recruiting
Facility Name
EyePoint Investigational Site
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Individual Site Status
Recruiting
Facility Name
EyePoint Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Individual Site Status
Recruiting
Facility Name
EyePoint Investigational Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14209
Country
United States
Individual Site Status
Recruiting
Facility Name
EyePoint Investigative Site
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Name
EyePoint Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Name
EyePoint Investigational Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluate the Safety of DEXYCU for the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract
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