Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution in Non-Infectious Anterior Uveitis (EGP-437-006)
Primary Purpose
Anterior Uveitis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone Phosphate Ophthalmic Solution
Prednisolone Acetate Ophthalmic (1%)
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Uveitis focused on measuring Iontophoresis, Ophthalmology, Non-Infectious Anterior Segment Uveitis
Eligibility Criteria
Inclusion Criteria:
- Age 12 to 85 years with a diagnosis of non-infectious anterior segment uveitis defined as an AC cell count of ≥ 11 cells
- Receive, understand, and sign a copy of the written informed consent form
- Be able to return for all study visits and willing to comply with all study-related instructions
Exclusion Criteria:
Sites / Locations
- Virginia Eye Consultants
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dexamethasone Phosphate Ophthalmic Solution
Prednisolone Acetate Ophthalmic (1%)
Arm Description
Dexamethasone phosphate ophthalmic solution (40 mg/mL)
Prednisolone Acetate Ophthalmic (1%)
Outcomes
Primary Outcome Measures
Proportion of subjects with an AC cell count of zero at Day 14
Secondary Outcome Measures
Full Information
NCT ID
NCT02517619
First Posted
August 5, 2015
Last Updated
July 24, 2018
Sponsor
Eyegate Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02517619
Brief Title
Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution in Non-Infectious Anterior Uveitis
Acronym
EGP-437-006
Official Title
A Prospective, Multi-Center, Randomized, Double-Masked, Positive Controlled, Phase 3 Clinical Trial Designed to Evaluate the Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution Compared to Prednisolone Acetate Ophthalmic Suspension (1%) in Patients With Non-Infectious Anterior Segment Uveitis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
January 16, 2016 (Actual)
Primary Completion Date
April 20, 2018 (Actual)
Study Completion Date
May 29, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eyegate Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of ocular iontophoresis with dexamethasone phosphate ophthalmic solution EGP-437 using the EyeGate® II Drug Delivery System (EGDS) compared to prednisolone acetate ophthalmic suspension (1%) in patients with non-infectious anterior segment uveitis.
Detailed Description
This will be a Phase 3, randomized, double-masked, parallel arm, positive-controlled non-inferiority study, in which up to 250 subjects (approximately 125 subjects per treatment arm) will be enrolled at up to 60 clinical sites. Patients with non-infectious anterior segment uveitis who are interested in participating in the study will be provided an informed consent form prior to screening. Screening/Baseline procedures which include BCVA, slit lamp examination, fundus exam, IOP by tonometry will be used to determine eligibility.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Uveitis
Keywords
Iontophoresis, Ophthalmology, Non-Infectious Anterior Segment Uveitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
251 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexamethasone Phosphate Ophthalmic Solution
Arm Type
Experimental
Arm Description
Dexamethasone phosphate ophthalmic solution (40 mg/mL)
Arm Title
Prednisolone Acetate Ophthalmic (1%)
Arm Type
Active Comparator
Arm Description
Prednisolone Acetate Ophthalmic (1%)
Intervention Type
Drug
Intervention Name(s)
Dexamethasone Phosphate Ophthalmic Solution
Other Intervention Name(s)
EGP-437
Intervention Description
40 mg/mL
Intervention Type
Drug
Intervention Name(s)
Prednisolone Acetate Ophthalmic (1%)
Other Intervention Name(s)
Pred Acetate (1%)
Intervention Description
Prednisolone Acetate (1%)
Primary Outcome Measure Information:
Title
Proportion of subjects with an AC cell count of zero at Day 14
Time Frame
Day 14 ± 2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 12 to 85 years with a diagnosis of non-infectious anterior segment uveitis defined as an AC cell count of ≥ 11 cells
Receive, understand, and sign a copy of the written informed consent form
Be able to return for all study visits and willing to comply with all study-related instructions
Exclusion Criteria:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John D. Sheppard, M.D.
Organizational Affiliation
Study Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Eye Consultants
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution in Non-Infectious Anterior Uveitis
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