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

NCT01505088 | Completed Phase 3

• 1 other identifier: EGP-437-004
• Study Type: interventional
• Target: 193
• Locations: 1 country
• Sites: 39

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.

Conditions

Anterior Uveitis

Keywords

Iontophoresis; Non-Infectious Anterior Segment Uveitis; Ophthalmology

Outcome Measures

Primary Outcomes (1)

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

  Proportion of patients with ACC count of zero at Day 14

  At Day 14 (plus or minus two days) following the first study treatment

Secondary Outcomes (12)

• Proportion of patients with ACC count of zero at Day 7

  At Day 7 (plus or minus two days) following the first study treatment

• Proportion of patients with ACC count of zero at Day 28

  At Day 28 (plus or minus two days) following the first study treatment

• Proportion of patients with ACC count of zero at Day 56

  At Day 56 (plus or minus seven days) following the first study treatment

• Mean change from baseline in ACC count and score at Day 7

  At Day 7 (plus or minus two days) following the first study treatment

• Mean change from baseline in ACC count and score at Day 14

  At Day 14 (plus or minus two days) following the first study treatment

Study Arms (2)

Iontophoretic Dexamethasone Phosphate Ophthalmic Solution

EXPERIMENTAL

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.

Drug: 40 mg/mL Dexamethasone phosphate ophthalmic solution; Drug: Placebo Eyedrops

Prednisolone Acetate Ophthalmic Suspension (1%)

ACTIVE COMPARATOR

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.

Drug: Prednisolone Acetate (1%) Eyedrops; Drug: 100 mM sodium citrate buffer solution

Interventions

40 mg/mL Dexamethasone phosphate ophthalmic solution DRUG

Transscleral iontophoresis delivery of EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis)

Iontophoretic Dexamethasone Phosphate Ophthalmic Solution

Prednisolone Acetate (1%) Eyedrops DRUG

Prednisolone acetate (1%) eyedrops

Prednisolone Acetate Ophthalmic Suspension (1%)

100 mM sodium citrate buffer solution DRUG

Transscleral iontophoresis delivery of 100 mM Sodium citrate buffer solution

Prednisolone Acetate Ophthalmic Suspension (1%)

Placebo Eyedrops DRUG

Placebo Eyedrops

Also known as: Saline/ Benzalkonium Chloride (BAK) Ophthalmic Solution

Iontophoretic Dexamethasone Phosphate Ophthalmic Solution

Eligibility Criteria

• Age: 12 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eyegate Pharmaceuticals, Inc.: lead

Study Sites (39)

Department of Ophthalmology at University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Arizona Eye Center

Chandler, Arizona, 85225, United States

Location

Associated Retina Consultants

Phoenix, Arizona, 85020, United States

Location

Retina-Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Location

Doheny Eye Medical Group

Los Angeles, California, 90033, United States

Location

Orange County Retina Medical Group

Santa Ana, California, 92705, United States

Location

Colorado Retina Associates

Golden, Colorado, 80401, United States

Location

Corneal Consultants of Colorado

Littleton, Colorado, 80120, United States

Location

Connecticut Retina Consultants, LLC

Bridgeport, Connecticut, 06606, United States

Location

Eye Center of Southern Connecticut

Hamden, Connecticut, 06518, United States

Location

Yale Eye Center

New Haven, Connecticut, 06510, United States

Location

The Eye Associates of Manatee, LLP

Bradenton, Florida, 34209, United States

Location

Levenson Eye Associates

Jacksonville, Florida, 32204, United States

Location

Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Location

Logan Ophthalmic Research

Tamarac, Florida, 33321, United States

Location

Emory Eye Center

Atlanta, Georgia, 30322, United States

Location

Advanced Eye Care

Fort Oglethorpe, Georgia, 30742, United States

Location

Illinois Retina Associates

Chicago, Illinois, 60612, United States

Location

Raj K. Maturi, M.D. PC

Indianapolis, Indiana, 46290, United States

Location

Ellsworth Uveitis and Retina Care

Ellsworth, Maine, 04605, United States

Location

Wilmer Eye Institute

Baltimore, Maryland, 21287, United States

Location

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

Location

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

Location

Massachusetts Eye Research and Surgery Institution

Cambridge, Massachusetts, 02142, United States

Location

Lifelong Vision Foundation

Chesterfield, Missouri, 63017, United States

Location

Tauber Eye Center

Kansas City, Missouri, 64111, United States

Location

Comprehensive Eye Care Ltd.

Washington, Missouri, 63090, United States

Location

Metropolitan Eye Research and Surgery Institute

Palisades Park, New Jersey, 07650, United States

Location

The New York Eye and Ear Infirmary

New York, New York, 10003, United States

Location

Charlotte Eye Ear Nose and Throat Associates

Matthews, North Carolina, 28105, United States

Location

Casey Eye Institute

Portland, Oregon, 97239, United States

Location

Scheie Eye Institute

Philadelphia, Pennsylvania, 19104, United States

Location

Mid-Atlantic Retina

Philadelphia, Pennsylvania, 19107, United States

Location

Southern College of Optometry

Memphis, Tennessee, 38104, United States

Location

Austin Retina Associates

Austin, Texas, 78705, United States

Location

Houston Eye Associates

Houston, Texas, 77025, United States

Location

Medical Center Ophthalmology Associates

San Antonio, Texas, 78240, United States

Location

Virginia Eye Consultants

Norfolk, Virginia, 23502, United States

Location

Spokane Eye Clinical Research

Spokane, Washington, 99204, United States

Location

MeSH Terms

Conditions

Uveitis, Anterior

Interventions

prednisolone acetate; Ophthalmic Solutions; Sodium Chloride; Benzalkonium Compounds

Condition Hierarchy (Ancestors)

Panuveitis; Uveitis; Uveal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Benzylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Study Officials

• John D. Sheppard, M.D.

  Virginia Eye Consultants

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2012
• First Posted: January 6, 2012
• Study Start: December 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: March 1, 2013
• Last Updated: March 29, 2013

Record last verified: 2013-03

Locations

US (39)