Safety and Efficacy Study of Iontophoresis and Dexamethasone Phosphate to Treat Anterior Uveitis
This study has been completed.
Sponsor:
Eyegate Pharmaceuticals, Inc.
Information provided by:
Eyegate Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00694135
First received: June 5, 2008
Last updated: August 27, 2010
Last verified: August 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Uveitis, Anterior |
Drug: EGP-437 1.6 mA-min at 0.4 with EyeGate® II System Drug: EGP-437 4.8 mA-min at 1.2 mA with EyeGate® II System Drug: EGP-437 10.0 mA-min at 2.5 mA with EyeGate® II System Drug: EGP-437 14.0 mA-min at 3.5 mA with EyeGate® II System |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Drug Information available for:
Dexamethasone
Dexamethasone phosphate
Dexamethasone acetate
Dexamethasone sodium phosphate
U.S. FDA Resources
Further study details as provided by Eyegate Pharmaceuticals, Inc.:
Primary Outcome Measures:
- Proportion of subjects with an ACC score of zero at Days 14 and 28 [ Time Frame: Prospective study, subjects followed for 28 days ] [ Designated as safety issue: Yes ]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 Frame: Prospective study, subjects followed for 28 days ] [ Designated as safety issue: Yes ]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 [ Time Frame: Prospective study, subjects followed for 28 days ] [ Designated as safety issue: Yes ]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 [ Time Frame: Prospective study, subjects followed for 28 days ] [ Designated as safety issue: Yes ]Change from baseline in anterior chamber cell score at Day 28
- Treatment emergent adverse events [ Time Frame: Prospective study, subjects followed for 28 days ] [ Designated as safety issue: Yes ]Treatment emergent adverse events
| Enrollment: | 40 |
| Study Start Date: | June 2008 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: EGP-437 1.6 mA-min at 0.4 mA
Ocular iontophoresis with EGP 437 1.6 mA-min at 0.4 mA
|
Drug: EGP-437 1.6 mA-min at 0.4 with EyeGate® II System
Ocular Iontophoresis with EGP-437 1.6 mA-min at 0.4 mA delivered via EyeGate® II Drug Delivery System
Other Name: Dexamethasone Phosphate Ophthalmic Solution
|
|
Active Comparator: EGP-437 4.8 mA-min at 1.2 mA
Ocular iontophoresis with EGP-437 4.8 mA-min at 1.2 mA
|
Drug: EGP-437 4.8 mA-min at 1.2 mA with EyeGate® II System
Ocular Iontophoresis with EGP-437 4.8 mA-min at 1.2 mA delivered via EyeGate® II Drug Delivery System
Other Name: Dexamethasone Phosphate Ophthalmic Solution
|
|
Active Comparator: EGP-437 10.0 mA-min at 2.5 mA
Ocular iontophoresis with EGP-437 10.0 mA-min at 2.5 mA
|
Drug: EGP-437 10.0 mA-min at 2.5 mA with EyeGate® II System
Ocular Iontophoresis with EGP-437 10.0 mA-min at 2.5 mA delivered via EyeGate® II Drug Delivery System
Other Name: Dexamethasone Phosphate Ophthalmic Solution
|
|
Active Comparator: EGP-437 14.0 mA-min at 3.5 mA
Ocular iontophoresis with EGP-437 14.0 mA-min at 3.5 mA
|
Drug: EGP-437 14.0 mA-min at 3.5 mA with EyeGate® II System
Ocular Iontophoresis with EGP-437 14.0 mA-min at 3.5 mA delivered via EyeGate® II Drug Delivery System
Other Name: Dexamethasone Phosphate Ophthalmic Solution
|
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.
Eligibility| Ages Eligible for Study: | 12 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00694135
Locations
| United States, Florida | |
| University of Miami | |
| Miami, Florida, United States, 33136 | |
| United States, Georgia | |
| Emory Eye Center | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Massachusetts | |
| Ophthalmic Consultants of Boston | |
| Boston, Massachusetts, United States, 02114 | |
| Massachusetts Eye Research and Surgery Institution | |
| Cambridge, Massachusetts, United States, 02142 | |
| United States, Missouri | |
| Comprehensive Eye Care Ltd. | |
| Washington, Missouri, United States, 63090 | |
| United States, New York | |
| New York Eye & Ear Infirmary | |
| New York, New York, United States, 10003 | |
| United States, Ohio | |
| Cleveland Eye Clinic | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Oregon | |
| Oregon Health Services University | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| Pennsylvania College of Optometry | |
| Elkins Park, Pennsylvania, United States, 19027 | |
| Scheie Eye Institue | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Tennessee | |
| Southern College of Optometry | |
| Memphis, Tennessee, United States, 38104 | |
| United States, Texas | |
| Texas Retina Associates | |
| Dallas, Texas, United States, 75231 | |
| United States, Virginia | |
| Virginia Eye Consultants | |
| Norfolk, Virginia, United States, 23502 | |
| India | |
| St. Johns Medical College and Hospital | |
| Bangalore, Karnataka, India, 560 037 | |
| Vittala International Institute of Ophthalmology | |
| Bangalore, Karnataka, India, 560 037 | |
| Narayana Nethralaya | |
| Bangalore, Karnataka, India, 560010 | |
| M. M. Joshi Eye Institute | |
| Hubli, Karnataka, India, 580 021 | |
| Kasturba Medical College and Hospital | |
| Manipal, Karnataka, India, 576104 | |
| Christian Medical College | |
| Vellore, Tamil Nadu, India, 632011 | |
Sponsors and Collaborators
Eyegate Pharmaceuticals, Inc.
Investigators
| Principal Investigator: | C. Stephen Foster, MD | Massachusetts Eye Research and Surgery Institution |
| Principal Investigator: | Michael Raizman, MD | Ophthalmic Consultants of Boston |
More Information
No publications provided
| Responsible Party: | Stephen From, President and Chief Executive Officer, Eyegate Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00694135 History of Changes |
| Other Study ID Numbers: | EGP-437-001 |
| Study First Received: | June 5, 2008 |
| Last Updated: | August 27, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Eyegate Pharmaceuticals, Inc.:
|
Iontophoresis Non-Infectious Acute Anterior Segment Uveitis Ophthalmology |
Additional relevant MeSH terms:
|
Uveitis Chorioretinitis Uveitis, Anterior Uveal Diseases Eye Diseases Retinitis Retinal Diseases Choroiditis Choroid Diseases Uveitis, Posterior Panuveitis Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate BB 1101 |
Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013