Safety and Efficacy Study of Iontophoresis and Dexamethasone Phosphate to Treat Anterior Uveitis - Full Text View

Sponsored by:	Eyegate Pharmaceuticals, Inc.
Information provided by:	Eyegate Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00694135

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 acute anterior segment uveitis.

Condition	Intervention	Phase
Uveitis, Anterior	Drug: Dexamethasone phosphate ophthalmic solution	Phase II

Drug Information available for: Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus

U.S. FDA Resources

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

Further study details as provided by Eyegate Pharmaceuticals, Inc.:

Primary Outcome Measures:

Anterior chamber cell score [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Anterior chamber flare [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]
Other slit lamp findings [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]
Ocular pain on a visual analog scale (VAS) [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]
Best corrected visual acuity [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]
Treatment emergent adverse events [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]

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	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)
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	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)

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 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.

Eligibility

Ages Eligible for Study:	12 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Non-infectious acute anterior uveitis
Any previous episodes of acute anterior uveitis at least 4 weeks before baseline

Exclusion Criteria:

Uveitis of infectious etiology
Intraocular pressure (IOP) ≥ 25 mmHg at baseline, a history of glaucoma, and/or patients who require ocular anti-hypertensive medications
Received treatment for any type of uveitis in either eye within 4 weeks of enrollment
Intermediate or posterior uveitis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00694135

Contacts

Contact: Jennifer Sugarman	781-788-8869	jsugarman@eyegatepharma.com
Contact: Amy Cohen	781-788-8869 ext 234	acohen@eyegatepharma.com

Locations

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

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

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

Keywords provided by Eyegate Pharmaceuticals, Inc.:

Iontophoresis
Non-Infectious Acute Anterior Segment Uveitis
Ophthalmology

Study placed in the following topic categories:

Dexamethasone
Panuveitis
Uveitis, Anterior

Uveitis
Eye Diseases
Dexamethasone acetate

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on January 16, 2009