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Safety and Efficacy Study of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution to Treat Non-Infectious Anterior Segment Uveitis

Primary Purpose

Anterior Uveitis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
40 mg/mL Dexamethasone phosphate ophthalmic solution
Prednisolone Acetate (1%) Eyedrops
100 mM sodium citrate buffer solution
Placebo Eyedrops
Sponsored by
Eyegate Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Uveitis focused on measuring Iontophoresis, Non-Infectious Anterior Segment Uveitis, Ophthalmology

Eligibility Criteria

12 Years - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female, age 12 to 85 years with a diagnosis of non-infectious anterior segment uveitis defined as an anterior chamber 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:

  • Have uveitis of infectious etiology
  • Have active intermediate or posterior uveitis
  • Known positive HLA-B27 with a severe (4+) fibrinoid reaction
  • Have previous anterior segment uveitis episode in the study eye ≤ 4 weeks prior to baseline visit
  • Have used topical corticosteroid treatment in the study eye ≤ 48 hours prior to baseline visit
  • Have used oral corticosteroid within the past 14 days prior to baseline
  • Have received intravitreal or sub-Tenon corticosteroid treatment in the study eye within the past 6 months prior to baseline visit
  • Currently using prescribed nonsteroidal anti-inflammatory agents (i.e., use of over-the-counter dosages is allowable) or prescribed immunosuppressive agents, unless the dose has been stable for the last six weeks and no change in dosing is anticipated for the duration of the study
  • Have IOP ≥ 25 mmHg at baseline, a history of glaucoma, or require ocular anti-hypertensive medications in the study eye
  • Be known steroid intraocular pressure responders in either eye
  • Have open wounds/skin disease on the forehead area where the iontophoresis return electrode will be applied
  • Have severe lesions of the eyelids or the ocular surface impeding the application of the iontophoresis applicator
  • Have known allergy to dexamethasone or dexamethasone phosphate or any medication to be used in this study
  • Have history or diagnosis of ocular herpes, corneal lesion of suspected herpetic origin, or Behçet's disease
  • Have monocular or BCVA worse than 20/80 in the fellow eye
  • Have optic neuritis of any origin
  • Have clinically suspected or confirmed central nervous system or ocular lymphoma
  • Planning to undergo elective ocular surgery during the study
  • Have active hyphema, pars planitis, choroiditis, clinically significant macular edema, toxoplasmosis scar, or vitreous hemorrhage
  • Have severe/serious ocular pathology or medical condition which may preclude study completion
  • Have pacemaker and/or any other electrical sensitive support system
  • Be pregnant or lactating female, or female of childbearing age and using inadequate birth control method
  • Have participated in another investigational device or drug study within 30 days of baseline visit
  • Have significant Fuch's Corneal Dystrophy

Sites / Locations

  • Department of Ophthalmology at University of Alabama at Birmingham
  • Arizona Eye Center
  • Associated Retina Consultants
  • Retina-Vitreous Associates Medical Group
  • Doheny Eye Medical Group
  • Orange County Retina Medical Group
  • Colorado Retina Associates
  • Corneal Consultants of Colorado
  • Connecticut Retina Consultants, LLC
  • Eye Center of Southern Connecticut
  • Yale Eye Center
  • The Eye Associates of Manatee, LLP
  • Levenson Eye Associates
  • Bascom Palmer Eye Institute
  • Logan Ophthalmic Research
  • Emory Eye Center
  • Advanced Eye Care
  • Illinois Retina Associates
  • Raj K. Maturi, M.D. PC
  • Ellsworth Uveitis and Retina Care
  • Wilmer Eye Institute
  • Massachusetts Eye and Ear Infirmary
  • Ophthalmic Consultants of Boston
  • Massachusetts Eye Research and Surgery Institution
  • Lifelong Vision Foundation
  • Tauber Eye Center
  • Comprehensive Eye Care Ltd.
  • Metropolitan Eye Research and Surgery Institute
  • The New York Eye and Ear Infirmary
  • Charlotte Eye Ear Nose and Throat Associates
  • Casey Eye Institute
  • Scheie Eye Institute
  • Mid-Atlantic Retina
  • Southern College of Optometry
  • Austin Retina Associates
  • Houston Eye Associates
  • Medical Center Ophthalmology Associates
  • Virginia Eye Consultants
  • Spokane Eye Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Iontophoretic Dexamethasone Phosphate Ophthalmic Solution

Prednisolone Acetate Ophthalmic Suspension (1%)

Arm Description

Dexamethasone phosphate (40 mg/mL) solution delivered by iontophoresis treatment consisting of 4.0 mA-min at 1.5 mA on Day 0 and Day 7 with accompanying placebo eyedrops (saline solution) for up to 28 days.

Placebo (100 mM sodium citrate buffer solution) iontophoresis treatment consisting of 4.0 mA-min at 1.5 mA on Day 0 and Day 7 with accompanying prednisolone acetate ophthalmic suspension (1%) (positive control) eyedrops for up to 28 days.

Outcomes

Primary Outcome Measures

Proportion of patients with with ACC count of zero at Day 14
Proportion of patients with ACC count of zero at Day 14

Secondary Outcome Measures

Proportion of patients with ACC count of zero at Day 7
Proportion of patients with ACC count of zero at Day 7
Proportion of patients with ACC count of zero at Day 28
Proportion of patients with ACC count of zero at Day 28
Proportion of patients with ACC count of zero at Day 56
The proportion of patients with ACC count of zero at Day 56
Mean change from baseline in ACC count and score at Day 7
Mean change from baseline in ACC count and score at Day 7
Mean change from baseline in ACC count and score at Day 14
Mean change from baseline in ACC count and score at Day 14
Mean change from baseline in ACC count and score at Day 28
Mean change from baseline in ACC count and score at Day 28
Mean change from baseline in ACC count and score at Day 56
Mean change from baseline in ACC count and score at Day 56
Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 7
Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 7
Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 14
Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 14
Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 28
Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 28
Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 56
Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 56
Time to anterior chamber cell count and score of zero
Time to anterior chamber cell count and score of zero

Full Information

First Posted
January 4, 2012
Last Updated
March 28, 2013
Sponsor
Eyegate Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01505088
Brief Title
Safety and Efficacy Study of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution to Treat Non-Infectious Anterior Segment Uveitis
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
March 2013
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
March 2013 (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
Anterior uveitis is a disorder of the eye associated with intraocular inflammation of the anterior portion of the uvea, particularly the iris and/or ciliary body. It is distinct from other iterations of uveitis such as posterior, diffuse and intermediate uveitis although it is the most common form of uveitis and accounts for approximately 75% of cases. In a Phase 1/2 study (EGP-437-001), the delivery of EGP-437 (40 mg/mL dexamethasone phosphate solution) at four different iontophoresis dose levels was studied in 40 subjects with non-infectious anterior segment uveitis. The study demonstrated that a single EGP-437 treatment: lowered anterior chamber cell (ACC) scores in the majority of patients without requiring additional treatment; produced low short-term systemic exposure to dexamethasone and dexamethasone phosphate; and produced the most beneficial effects in the 1.6 and 4.8 mA-min dose groups; and caused mainly minor AEs and no non-ocular systemic corticosteroid mediated effects were observed. The Phase 3 study is intended to confirm and extend the results from the Phase 2 study. The study is designed to assess the safety and efficacy Ocular Iontophoresis with EGP-437 4.0 mA-min at 1.5 mA and accompanying placebo eyedrops in comparison to Ocular Iontophoresis with sodium citrate buffer solution 4.0 mA-min at 1.5 mA and accompanying prednisolone acetate (1%) eyedrops for the treatment of non-infectious anterior segment uveitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Uveitis
Keywords
Iontophoresis, Non-Infectious Anterior Segment Uveitis, Ophthalmology

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
193 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Iontophoretic Dexamethasone Phosphate Ophthalmic Solution
Arm Type
Experimental
Arm Description
Dexamethasone phosphate (40 mg/mL) solution delivered by iontophoresis treatment consisting of 4.0 mA-min at 1.5 mA on Day 0 and Day 7 with accompanying placebo eyedrops (saline solution) for up to 28 days.
Arm Title
Prednisolone Acetate Ophthalmic Suspension (1%)
Arm Type
Active Comparator
Arm Description
Placebo (100 mM sodium citrate buffer solution) iontophoresis treatment consisting of 4.0 mA-min at 1.5 mA on Day 0 and Day 7 with accompanying prednisolone acetate ophthalmic suspension (1%) (positive control) eyedrops for up to 28 days.
Intervention Type
Drug
Intervention Name(s)
40 mg/mL Dexamethasone phosphate ophthalmic solution
Intervention Description
Transscleral iontophoresis delivery of EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis)
Intervention Type
Drug
Intervention Name(s)
Prednisolone Acetate (1%) Eyedrops
Intervention Description
Prednisolone acetate (1%) eyedrops
Intervention Type
Drug
Intervention Name(s)
100 mM sodium citrate buffer solution
Intervention Description
Transscleral iontophoresis delivery of 100 mM Sodium citrate buffer solution
Intervention Type
Drug
Intervention Name(s)
Placebo Eyedrops
Other Intervention Name(s)
Saline/ Benzalkonium Chloride (BAK) Ophthalmic Solution
Intervention Description
Placebo Eyedrops
Primary Outcome Measure Information:
Title
Proportion of patients with with ACC count of zero at Day 14
Description
Proportion of patients with ACC count of zero at Day 14
Time Frame
At Day 14 (plus or minus two days) following the first study treatment
Secondary Outcome Measure Information:
Title
Proportion of patients with ACC count of zero at Day 7
Description
Proportion of patients with ACC count of zero at Day 7
Time Frame
At Day 7 (plus or minus two days) following the first study treatment
Title
Proportion of patients with ACC count of zero at Day 28
Description
Proportion of patients with ACC count of zero at Day 28
Time Frame
At Day 28 (plus or minus two days) following the first study treatment
Title
Proportion of patients with ACC count of zero at Day 56
Description
The proportion of patients with ACC count of zero at Day 56
Time Frame
At Day 56 (plus or minus seven days) following the first study treatment
Title
Mean change from baseline in ACC count and score at Day 7
Description
Mean change from baseline in ACC count and score at Day 7
Time Frame
At Day 7 (plus or minus two days) following the first study treatment
Title
Mean change from baseline in ACC count and score at Day 14
Description
Mean change from baseline in ACC count and score at Day 14
Time Frame
At Day 14 (plus or minus two days) following the first study treatment
Title
Mean change from baseline in ACC count and score at Day 28
Description
Mean change from baseline in ACC count and score at Day 28
Time Frame
At Day 28 (plus or minus two days) following the first study treatment
Title
Mean change from baseline in ACC count and score at Day 56
Description
Mean change from baseline in ACC count and score at Day 56
Time Frame
At Day 56 (plus or minus seven days) following the first study treatment
Title
Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 7
Description
Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 7
Time Frame
At Day 7 (plus or minus two days) following the first study treatment
Title
Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 14
Description
Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 14
Time Frame
At Day 14 (plus or minus two days) following the first study treatment
Title
Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 28
Description
Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 28
Time Frame
At Day 28 (plus or minus two days) following the first study treatment
Title
Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 56
Description
Proportion of subjects with ACC count and score reduction from baseline of one or more units at Day 56
Time Frame
At Day 56 (plus or minus seven days) following the first study treatment
Title
Time to anterior chamber cell count and score of zero
Description
Time to anterior chamber cell count and score of zero
Time Frame
Up to 56 days (plus or minus seven days) following the first study treatment

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: Male or female, age 12 to 85 years with a diagnosis of non-infectious anterior segment uveitis defined as an anterior chamber 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: Have uveitis of infectious etiology Have active intermediate or posterior uveitis Known positive HLA-B27 with a severe (4+) fibrinoid reaction Have previous anterior segment uveitis episode in the study eye ≤ 4 weeks prior to baseline visit Have used topical corticosteroid treatment in the study eye ≤ 48 hours prior to baseline visit Have used oral corticosteroid within the past 14 days prior to baseline Have received intravitreal or sub-Tenon corticosteroid treatment in the study eye within the past 6 months prior to baseline visit Currently using prescribed nonsteroidal anti-inflammatory agents (i.e., use of over-the-counter dosages is allowable) or prescribed immunosuppressive agents, unless the dose has been stable for the last six weeks and no change in dosing is anticipated for the duration of the study Have IOP ≥ 25 mmHg at baseline, a history of glaucoma, or require ocular anti-hypertensive medications in the study eye Be known steroid intraocular pressure responders in either eye Have open wounds/skin disease on the forehead area where the iontophoresis return electrode will be applied Have severe lesions of the eyelids or the ocular surface impeding the application of the iontophoresis applicator Have known allergy to dexamethasone or dexamethasone phosphate or any medication to be used in this study Have history or diagnosis of ocular herpes, corneal lesion of suspected herpetic origin, or Behçet's disease Have monocular or BCVA worse than 20/80 in the fellow eye Have optic neuritis of any origin Have clinically suspected or confirmed central nervous system or ocular lymphoma Planning to undergo elective ocular surgery during the study Have active hyphema, pars planitis, choroiditis, clinically significant macular edema, toxoplasmosis scar, or vitreous hemorrhage Have severe/serious ocular pathology or medical condition which may preclude study completion Have pacemaker and/or any other electrical sensitive support system Be pregnant or lactating female, or female of childbearing age and using inadequate birth control method Have participated in another investigational device or drug study within 30 days of baseline visit Have significant Fuch's Corneal Dystrophy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John D. Sheppard, M.D.
Organizational Affiliation
Virginia Eye Consultants
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology at University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Arizona Eye Center
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85225
Country
United States
Facility Name
Associated Retina Consultants
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Retina-Vitreous Associates Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Doheny Eye Medical Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Orange County Retina Medical Group
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Colorado Retina Associates
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
Corneal Consultants of Colorado
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Connecticut Retina Consultants, LLC
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
Facility Name
Eye Center of Southern Connecticut
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Yale Eye Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
The Eye Associates of Manatee, LLP
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Facility Name
Levenson Eye Associates
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Bascom Palmer Eye Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Logan Ophthalmic Research
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Emory Eye Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Advanced Eye Care
City
Fort Oglethorpe
State/Province
Georgia
ZIP/Postal Code
30742
Country
United States
Facility Name
Illinois Retina Associates
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Raj K. Maturi, M.D. PC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Ellsworth Uveitis and Retina Care
City
Ellsworth
State/Province
Maine
ZIP/Postal Code
04605
Country
United States
Facility Name
Wilmer Eye Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts Eye and Ear Infirmary
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Ophthalmic Consultants of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Massachusetts Eye Research and Surgery Institution
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02142
Country
United States
Facility Name
Lifelong Vision Foundation
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Tauber Eye Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Comprehensive Eye Care Ltd.
City
Washington
State/Province
Missouri
ZIP/Postal Code
63090
Country
United States
Facility Name
Metropolitan Eye Research and Surgery Institute
City
Palisades Park
State/Province
New Jersey
ZIP/Postal Code
07650
Country
United States
Facility Name
The New York Eye and Ear Infirmary
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Charlotte Eye Ear Nose and Throat Associates
City
Matthews
State/Province
North Carolina
ZIP/Postal Code
28105
Country
United States
Facility Name
Casey Eye Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Scheie Eye Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Mid-Atlantic Retina
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Southern College of Optometry
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Austin Retina Associates
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Houston Eye Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Facility Name
Medical Center Ophthalmology Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Virginia Eye Consultants
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Spokane Eye Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States

12. IPD Sharing Statement

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Safety and Efficacy Study of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution to Treat Non-Infectious Anterior Segment Uveitis

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