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

Inclusion Criteria:

• Male or female, age 12 to 85 years with a diagnosis of non-infectious anterior segmentuveitis 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-relatedinstructions

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 tobaseline visit

• Have used topical corticosteroid treatment in the study eye ≤ 48 hours prior tobaseline visit

• Have used oral corticosteroid within the past 14 days prior to baseline

• Have received intravitreal or sub-Tenon corticosteroid treatment in the study eyewithin the past 6 months prior to baseline visit

• Currently using prescribed nonsteroidal anti-inflammatory agents (i.e., use ofover-the-counter dosages is allowable) or prescribed immunosuppressive agents, unlessthe dose has been stable for the last six weeks and no change in dosing is anticipatedfor the duration of the study

• Have IOP ≥ 25 mmHg at baseline, a history of glaucoma, or require ocularanti-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 returnelectrode will be applied

• Have severe lesions of the eyelids or the ocular surface impeding the application ofthe iontophoresis applicator

• Have known allergy to dexamethasone or dexamethasone phosphate or any medication to beused in this study

• Have history or diagnosis of ocular herpes, corneal lesion of suspected herpeticorigin, 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 studycompletion

• Have pacemaker and/or any other electrical sensitive support system

• Be pregnant or lactating female, or female of childbearing age and using inadequatebirth control method

• Have participated in another investigational device or drug study within 30 days ofbaseline visit

• Have significant Fuch's Corneal Dystrophy