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Safety and Efficacy Study of Iontophoresis and Dexamethasone Phosphate to Treat Anterior Uveitis

Primary Purpose

Uveitis, Anterior

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
EGP-437 1.6 mA-min at 0.4 with EyeGate® II System
EGP-437 4.8 mA-min at 1.2 mA with EyeGate® II System
EGP-437 10.0 mA-min at 2.5 mA with EyeGate® II System
EGP-437 14.0 mA-min at 3.5 mA with EyeGate® II System
Sponsored by
Eyegate Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

• Non-infectious anterior uveitis

Exclusion Criteria:

  • Uveitis of infectious etiology
  • Previous anterior uveitis episode ≤ 4 weeks prior to baseline
  • Intraocular pressure (IOP) ≥ 25 mmHg at baseline, a history of glaucoma, and/or patients who require ocular anti-hypertensive medications
  • Topical corticosteroid treatment in either eye < 48 hours prior to baseline
  • Oral corticosteroid or intraorbital corticosteroid treatment in either eye < 2 weeks prior to baseline
  • Active intermediate or posterior uveitis

Sites / Locations

  • University of Miami
  • Emory Eye Center
  • Ophthalmic Consultants of Boston
  • Massachusetts Eye Research and Surgery Institution
  • Comprehensive Eye Care Ltd.
  • New York Eye & Ear Infirmary
  • Cleveland Eye Clinic
  • Oregon Health Services University
  • Pennsylvania College of Optometry
  • Scheie Eye Institue
  • Southern College of Optometry
  • Texas Retina Associates
  • Virginia Eye Consultants
  • St. Johns Medical College and Hospital
  • Vittala International Institute of Ophthalmology
  • Narayana Nethralaya
  • M. M. Joshi Eye Institute
  • Kasturba Medical College and Hospital
  • Christian Medical College

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

EGP-437 1.6 mA-min at 0.4 mA

EGP-437 4.8 mA-min at 1.2 mA

EGP-437 10.0 mA-min at 2.5 mA

EGP-437 14.0 mA-min at 3.5 mA

Arm Description

Ocular iontophoresis with EGP 437 1.6 mA-min at 0.4 mA

Ocular iontophoresis with EGP-437 4.8 mA-min at 1.2 mA

Ocular iontophoresis with EGP-437 10.0 mA-min at 2.5 mA

Ocular iontophoresis with EGP-437 14.0 mA-min at 3.5 mA

Outcomes

Primary Outcome Measures

Proportion of subjects with an ACC score of zero at Days 14 and 28
Proportion of subjects with an anterior chamber cell (ACC) score of zero at Days 14 and 28

Secondary Outcome Measures

Time to ACC score of zero
Time to anterior chamber cell score of zero
Proportion of subjects with a reduction of one full ACC score or more from baseline at Day 28
Proportion of subjects with a reduction of one full anterior chamber cell score or more (≥ 0.5 decrease) from baseline at Day 28
Change from baseline in ACC score at Day 28
Change from baseline in anterior chamber cell score at Day 28
Treatment emergent adverse events
Treatment emergent adverse events

Full Information

First Posted
June 5, 2008
Last Updated
August 27, 2010
Sponsor
Eyegate Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00694135
Brief Title
Safety and Efficacy Study of Iontophoresis and Dexamethasone Phosphate to Treat Anterior Uveitis
Official Title
A Prospective, Multi-Center, Randomized, Double-Masked, Safety, Tolerability and Efficacy Study of Four Iontophoretic Doses of Dexamethasone Phosphate Ophthalmic Solution in Patients With Non-Infectious Anterior Segment Uveitis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

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 define a safe and effective dose of iontophoretic delivery of dexamethasone phosphate ophthalmic solution using the EyeGate® II Drug Delivery System in patients with non-infectious anterior segment uveitis.
Detailed Description
This is a randomized, double-masked, parallel group, dose-comparison, exploratory study of four doses of iontophoretic delivery of dexamethasone phosphate ophthalmic solution in patients with non-infectious anterior segment uveitis. The current study will evaluate the safety, tolerability, and efficacy of this technology at the four dose levels to determine a safe effective dose appropriate for future trials.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EGP-437 1.6 mA-min at 0.4 mA
Arm Type
Active Comparator
Arm Description
Ocular iontophoresis with EGP 437 1.6 mA-min at 0.4 mA
Arm Title
EGP-437 4.8 mA-min at 1.2 mA
Arm Type
Active Comparator
Arm Description
Ocular iontophoresis with EGP-437 4.8 mA-min at 1.2 mA
Arm Title
EGP-437 10.0 mA-min at 2.5 mA
Arm Type
Active Comparator
Arm Description
Ocular iontophoresis with EGP-437 10.0 mA-min at 2.5 mA
Arm Title
EGP-437 14.0 mA-min at 3.5 mA
Arm Type
Active Comparator
Arm Description
Ocular iontophoresis with EGP-437 14.0 mA-min at 3.5 mA
Intervention Type
Drug
Intervention Name(s)
EGP-437 1.6 mA-min at 0.4 with EyeGate® II System
Other Intervention Name(s)
Dexamethasone Phosphate Ophthalmic Solution
Intervention Description
Ocular Iontophoresis with EGP-437 1.6 mA-min at 0.4 mA delivered via EyeGate® II Drug Delivery System
Intervention Type
Drug
Intervention Name(s)
EGP-437 4.8 mA-min at 1.2 mA with EyeGate® II System
Other Intervention Name(s)
Dexamethasone Phosphate Ophthalmic Solution
Intervention Description
Ocular Iontophoresis with EGP-437 4.8 mA-min at 1.2 mA delivered via EyeGate® II Drug Delivery System
Intervention Type
Drug
Intervention Name(s)
EGP-437 10.0 mA-min at 2.5 mA with EyeGate® II System
Other Intervention Name(s)
Dexamethasone Phosphate Ophthalmic Solution
Intervention Description
Ocular Iontophoresis with EGP-437 10.0 mA-min at 2.5 mA delivered via EyeGate® II Drug Delivery System
Intervention Type
Drug
Intervention Name(s)
EGP-437 14.0 mA-min at 3.5 mA with EyeGate® II System
Other Intervention Name(s)
Dexamethasone Phosphate Ophthalmic Solution
Intervention Description
Ocular Iontophoresis with EGP-437 14.0 mA-min at 3.5 mA delivered via EyeGate® II Drug Delivery System
Primary Outcome Measure Information:
Title
Proportion of subjects with an ACC score of zero at Days 14 and 28
Description
Proportion of subjects with an anterior chamber cell (ACC) score of zero at Days 14 and 28
Time Frame
Prospective study, subjects followed for 28 days
Secondary Outcome Measure Information:
Title
Time to ACC score of zero
Description
Time to anterior chamber cell score of zero
Time Frame
Prospective study, subjects followed for 28 days
Title
Proportion of subjects with a reduction of one full ACC score or more from baseline at Day 28
Description
Proportion of subjects with a reduction of one full anterior chamber cell score or more (≥ 0.5 decrease) from baseline at Day 28
Time Frame
Prospective study, subjects followed for 28 days
Title
Change from baseline in ACC score at Day 28
Description
Change from baseline in anterior chamber cell score at Day 28
Time Frame
Prospective study, subjects followed for 28 days
Title
Treatment emergent adverse events
Description
Treatment emergent adverse events
Time Frame
Prospective study, subjects followed for 28 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: • Non-infectious anterior uveitis Exclusion Criteria: Uveitis of infectious etiology Previous anterior uveitis episode ≤ 4 weeks prior to baseline Intraocular pressure (IOP) ≥ 25 mmHg at baseline, a history of glaucoma, and/or patients who require ocular anti-hypertensive medications Topical corticosteroid treatment in either eye < 48 hours prior to baseline Oral corticosteroid or intraorbital corticosteroid treatment in either eye < 2 weeks prior to baseline Active intermediate or posterior uveitis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
C. Stephen Foster, MD
Organizational Affiliation
Massachusetts Eye Research and Surgery Institution
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Raizman, MD
Organizational Affiliation
Ophthalmic Consultants of Boston
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Emory Eye Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
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
Comprehensive Eye Care Ltd.
City
Washington
State/Province
Missouri
ZIP/Postal Code
63090
Country
United States
Facility Name
New York Eye & Ear Infirmary
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Cleveland Eye Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Oregon Health Services University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Pennsylvania College of Optometry
City
Elkins Park
State/Province
Pennsylvania
ZIP/Postal Code
19027
Country
United States
Facility Name
Scheie Eye Institue
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Southern College of Optometry
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Texas Retina Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Virginia Eye Consultants
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
St. Johns Medical College and Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 037
Country
India
Facility Name
Vittala International Institute of Ophthalmology
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 037
Country
India
Facility Name
Narayana Nethralaya
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560010
Country
India
Facility Name
M. M. Joshi Eye Institute
City
Hubli
State/Province
Karnataka
ZIP/Postal Code
580 021
Country
India
Facility Name
Kasturba Medical College and Hospital
City
Manipal
State/Province
Karnataka
ZIP/Postal Code
576104
Country
India
Facility Name
Christian Medical College
City
Vellore
State/Province
Tamil Nadu
ZIP/Postal Code
632011
Country
India

12. IPD Sharing Statement

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Safety and Efficacy Study of Iontophoresis and Dexamethasone Phosphate to Treat Anterior Uveitis

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