Safety and Efficacy Study of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution to Treat Non-Infectious Anterior Segment Uveitis
A Prospective, Multi-Center, Randomized, Double-Masked, Positive-Controlled Phase 3 Clinical Trial Designed to Evaluate the Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution Compared to Prednisolone Acetate Ophthalmic Suspension (1%) in Patients With Non-Infectious Anterior Segment Uveitis
  • Phase

    Phase 3
  • Study Type

  • Status

    Completed No Results Posted
  • Intervention/Treatment

    sodium citrate urea prednisone ...
  • Study Participants

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.
Anterior uveitis is a disorder of the eye associated with intraocular inflammation of the anterior portion of the uvea, particularly the iris and/or ciliary body. It is distinct from other iterations of uveitis such as posterior, diffuse and intermediate uveitis although it is the most common form of uveitis and accounts for approximately 75% of cases.

In a Phase 1/2 study (EGP-437-001), the delivery of EGP-437 (40 mg/mL dexamethasone phosphate solution) at four different iontophoresis dose levels was studied in 40 subjects with non-infectious anterior segment uveitis. The study demonstrated that a single EGP-437 treatment: lowered anterior chamber cell (ACC) scores in the majority of patients without requiring additional treatment; produced low short-term systemic exposure to dexamethasone and dexamethasone phosphate; and produced the most beneficial effects in the 1.6 and 4.8 mA-min dose groups; and caused mainly minor AEs and no non-ocular systemic corticosteroid mediated effects were observed.

The Phase 3 study is intended to confirm and extend the results from the Phase 2 study. The study is designed to assess the safety and efficacy Ocular Iontophoresis with EGP-437 4.0 mA-min at 1.5 mA and accompanying placebo eyedrops in comparison to Ocular Iontophoresis with sodium citrate buffer solution 4.0 mA-min at 1.5 mA and accompanying prednisolone acetate (1%) eyedrops for the treatment of non-infectious anterior segment uveitis.
Study Started
Dec 31
Primary Completion
Feb 28
Study Completion
Mar 31
Last Update
Mar 29

Drug 40 mg/mL Dexamethasone phosphate ophthalmic solution

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

Drug Prednisolone Acetate (1%) Eyedrops

Prednisolone acetate (1%) eyedrops

Drug 100 mM sodium citrate buffer solution

Transscleral iontophoresis delivery of 100 mM Sodium citrate buffer solution

Drug Placebo Eyedrops

Placebo Eyedrops

  • Other names: Saline/ Benzalkonium Chloride (BAK) Ophthalmic Solution

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.

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.


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
No Results Posted