Safety and Efficacy Study of Iontophoresis and Dexamethasone Phosphate to Treat Anterior Uveitis

Study Overview
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Brief Summary
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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 anterior segment uveitis.

Detailed Description
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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 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.

Official Title
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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 Anterior Segment Uveitis

Conditions
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Uveitis, Anterior

Intervention / Treatment
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* Drug: EGP-437 1.6 mA-min at 0.4 with EyeGate® II System
* Drug: EGP-437 4.8 mA-min at 1.2 mA with EyeGate® II System
* Drug: EGP-437 10.0 mA-min at 2.5 mA with EyeGate® II System
* Drug: EGP-437 14.0 mA-min at 3.5 mA with EyeGate® II System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Non-infectious anterior uveitis Exclusion Criteria: Uveitis of infectious etiology Previous anterior uveitis episode ≤ 4 weeks prior to baseline Intraocular pressure (IOP) ≥ 25 mmHg at baseline, a history of glaucoma, and/or patients who require ocular anti-hypertensive medications Topical corticosteroid treatment in either eye < 48 hours prior to baseline Oral corticosteroid or intraorbital corticosteroid treatment in either eye < 2 weeks prior to baseline Active intermediate or posterior uveitis

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EGP-437 1.6 mA-min at 0.4 mA<br>Ocular iontophoresis with EGP 437 1.6 mA-min at 0.4 mA | Drug: EGP-437 1.6 mA-min at 0.4 with EyeGate® II System<br>* Ocular Iontophoresis with EGP-437 1.6 mA-min at 0.4 mA delivered via EyeGate® II Drug Delivery System<br>* Other names: Dexamethasone Phosphate Ophthalmic Solution;|
| Active Comparator: EGP-437 4.8 mA-min at 1.2 mA<br>Ocular iontophoresis with EGP-437 4.8 mA-min at 1.2 mA | Drug: EGP-437 4.8 mA-min at 1.2 mA with EyeGate® II System<br>* Ocular Iontophoresis with EGP-437 4.8 mA-min at 1.2 mA delivered via EyeGate® II Drug Delivery System<br>* Other names: Dexamethasone Phosphate Ophthalmic Solution;|
| Active Comparator: EGP-437 10.0 mA-min at 2.5 mA<br>Ocular iontophoresis with EGP-437 10.0 mA-min at 2.5 mA | Drug: EGP-437 10.0 mA-min at 2.5 mA with EyeGate® II System<br>* Ocular Iontophoresis with EGP-437 10.0 mA-min at 2.5 mA delivered via EyeGate® II Drug Delivery System<br>* Other names: Dexamethasone Phosphate Ophthalmic Solution;|
| Active Comparator: EGP-437 14.0 mA-min at 3.5 mA<br>Ocular iontophoresis with EGP-437 14.0 mA-min at 3.5 mA | Drug: EGP-437 14.0 mA-min at 3.5 mA with EyeGate® II System<br>* Ocular Iontophoresis with EGP-437 14.0 mA-min at 3.5 mA delivered via EyeGate® II Drug Delivery System<br>* Other names: Dexamethasone Phosphate Ophthalmic Solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with an ACC score of zero at Days 14 and 28 | Proportion of subjects with an anterior chamber cell (ACC) score of zero at Days 14 and 28 | Prospective study, subjects followed for 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to ACC score of zero | Time to anterior chamber cell score of zero | Prospective study, subjects followed for 28 days | 
| Proportion of subjects with a reduction of one full ACC score or more from baseline at Day 28 | Proportion of subjects with a reduction of one full anterior chamber cell score or more (≥ 0.5 decrease) from baseline at Day 28 | Prospective study, subjects followed for 28 days | 
| Change from baseline in ACC score at Day 28 | Change from baseline in anterior chamber cell score at Day 28 | Prospective study, subjects followed for 28 days | 
| Treatment emergent adverse events | Treatment emergent adverse events | Prospective study, subjects followed for 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Iontophoresis, Non-Infectious Acute Anterior Segment Uveitis, Ophthalmology