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Sponsored by: |
Eyegate Pharmaceuticals, Inc. |
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Information provided by: | Eyegate Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00694135 |
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 acute anterior segment uveitis.
Condition | Intervention | Phase |
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Uveitis, Anterior |
Drug: Dexamethasone phosphate ophthalmic solution |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
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 Acute Anterior Segment Uveitis |
Estimated Enrollment: | 32 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
1.6 mA-min at 0.4 mA
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Drug: Dexamethasone phosphate ophthalmic solution
Transcleral iontophoretic delivery of dexamethasone phosphate ophthalmic solution. Dexamethasone phosphate ophthalmic solution as a ready to use 40 mg/mL solution (preservative free and intended for single-use only)
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2: Active Comparator
4.8 mA-min at 1.2 mA
|
Drug: Dexamethasone phosphate ophthalmic solution
Transcleral iontophoretic delivery of dexamethasone phosphate ophthalmic solution. Dexamethasone phosphate ophthalmic solution as a ready to use 40 mg/mL solution (preservative free and intended for single-use only)
|
3: Active Comparator
10.0 mA-min at 2.5 mA
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Drug: Dexamethasone phosphate ophthalmic solution
Transcleral iontophoretic delivery of dexamethasone phosphate ophthalmic solution. Dexamethasone phosphate ophthalmic solution as a ready to use 40 mg/mL solution (preservative free and intended for single-use only)
|
4: Active Comparator
14.0 mA-min at 3.5 mA
|
Drug: Dexamethasone phosphate ophthalmic solution
Transcleral iontophoretic delivery of dexamethasone phosphate ophthalmic solution. Dexamethasone phosphate ophthalmic solution as a ready to use 40 mg/mL solution (preservative free and intended for single-use only)
|
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 acute 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.
Ages Eligible for Study: | 12 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jennifer Sugarman | 781-788-8869 | jsugarman@eyegatepharma.com |
Contact: Amy Cohen | 781-788-8869 ext 234 | acohen@eyegatepharma.com |
United States, Illinois | |
University of Illinois at Chicago | Not yet recruiting |
Chicago, Illinois, United States, 60612 | |
Contact: Catherine Crooke 312-996-4747 crooke@uic.edu | |
Principal Investigator: Debra Goldstein, MD | |
United States, Massachusetts | |
Massachusetts Eye Research and Surgery Institution | Recruiting |
Cambridge, Massachusetts, United States, 02142 | |
Contact: Nita Patel 617-621-6377 ext 155 npatel@mersi.us | |
Principal Investigator: C. Stephen Foster, MD | |
Ophthalmic Consultants of Boston | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Jackie Pereira 617-367-4800 jpereira@eyeboston.com | |
Principal Investigator: Michael Raizman, MD | |
United States, New York | |
New York Eye & Ear Infirmary | Recruiting |
New York, New York, United States, 10003 | |
Contact: Katy Tai 212-979-4515 ktai@nyee.edu | |
Principal Investigator: C. Michael Samson, MD | |
United States, Texas | |
Texas Retina Associates | Recruiting |
Dallas, Texas, United States, 75231 | |
Contact: Jean Arnwine 214-692-6885 jarnwine@texasretina.com | |
Principal Investigator: Robert Wang, MD | |
United States, Virginia | |
Virginia Eye Consultants | Recruiting |
Norfolk, Virginia, United States, 23502 | |
Contact: Nancy Crawfold 757-622-2200 ncrawford@vec2020.com | |
Principal Investigator: John Sheppard, MD |
Principal Investigator: | C. Stephen Foster, MD | Massachusetts Eye Research and Surgery Institution |
Principal Investigator: | Michael Raizman, MD | Ophthalmic Consultants of Boston |
Responsible Party: | Eyegate Pharmaceuticals, Inc. ( Stephen From, President and Chief Executive Officer ) |
Study ID Numbers: | EGP-437-001 |
Study First Received: | June 5, 2008 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00694135 |
Health Authority: | United States: Food and Drug Administration |
Iontophoresis Non-Infectious Acute Anterior Segment Uveitis Ophthalmology |
Dexamethasone Panuveitis Uveitis, Anterior |
Uveitis Eye Diseases Dexamethasone acetate |
Anti-Inflammatory Agents Uveal Diseases Antineoplastic Agents, Hormonal Antineoplastic Agents Physiological Effects of Drugs Gastrointestinal Agents Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics |
Glucocorticoids Hormones Pharmacologic Actions Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Central Nervous System Agents |