Safety and Efficacy Study of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution to Treat Non-Infectious Anterior Segment Uveitis
Anterior Uveitis
About this trial
This is an interventional treatment trial for Anterior Uveitis focused on measuring Iontophoresis, Non-Infectious Anterior Segment Uveitis, Ophthalmology
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Have optic neuritis of any origin
- Have clinically suspected or confirmed central nervous system or ocular lymphoma
- Planning to undergo elective ocular surgery during the study
- Have active hyphema, pars planitis, choroiditis, clinically significant macular edema, toxoplasmosis scar, or vitreous hemorrhage
- Have severe/serious ocular pathology or medical condition which may preclude study completion
- Have pacemaker and/or any other electrical sensitive support system
- Be pregnant or lactating female, or female of childbearing age and using inadequate birth control method
- Have participated in another investigational device or drug study within 30 days of baseline visit
- Have significant Fuch's Corneal Dystrophy
Sites / Locations
- Department of Ophthalmology at University of Alabama at Birmingham
- Arizona Eye Center
- Associated Retina Consultants
- Retina-Vitreous Associates Medical Group
- Doheny Eye Medical Group
- Orange County Retina Medical Group
- Colorado Retina Associates
- Corneal Consultants of Colorado
- Connecticut Retina Consultants, LLC
- Eye Center of Southern Connecticut
- Yale Eye Center
- The Eye Associates of Manatee, LLP
- Levenson Eye Associates
- Bascom Palmer Eye Institute
- Logan Ophthalmic Research
- Emory Eye Center
- Advanced Eye Care
- Illinois Retina Associates
- Raj K. Maturi, M.D. PC
- Ellsworth Uveitis and Retina Care
- Wilmer Eye Institute
- Massachusetts Eye and Ear Infirmary
- Ophthalmic Consultants of Boston
- Massachusetts Eye Research and Surgery Institution
- Lifelong Vision Foundation
- Tauber Eye Center
- Comprehensive Eye Care Ltd.
- Metropolitan Eye Research and Surgery Institute
- The New York Eye and Ear Infirmary
- Charlotte Eye Ear Nose and Throat Associates
- Casey Eye Institute
- Scheie Eye Institute
- Mid-Atlantic Retina
- Southern College of Optometry
- Austin Retina Associates
- Houston Eye Associates
- Medical Center Ophthalmology Associates
- Virginia Eye Consultants
- Spokane Eye Clinical Research
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Iontophoretic Dexamethasone Phosphate Ophthalmic Solution
Prednisolone Acetate Ophthalmic Suspension (1%)
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.
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.