Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution in Non-Infectious Anterior Uveitis

Study Overview
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Brief Summary
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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.

Detailed Description
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This will be a Phase 3, randomized, double-masked, parallel arm, positive-controlled non-inferiority study, in which up to 250 subjects (approximately 125 subjects per treatment arm) will be enrolled at up to 60 clinical sites. Patients with non-infectious anterior segment uveitis who are interested in participating in the study will be provided an informed consent form prior to screening. Screening/Baseline procedures which include BCVA, slit lamp examination, fundus exam, IOP by tonometry will be used to determine eligibility.

Official Title
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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

Conditions
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Anterior Uveitis

Intervention / Treatment
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* Drug: Dexamethasone Phosphate Ophthalmic Solution
* Drug: Prednisolone Acetate Ophthalmic (1%)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 12 to 85 years with a diagnosis of non-infectious anterior segment uveitis defined as an AC 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:

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 |
| --- | --- |
| Experimental: Dexamethasone Phosphate Ophthalmic Solution<br>Dexamethasone phosphate ophthalmic solution (40 mg/mL) | Drug: Dexamethasone Phosphate Ophthalmic Solution<br>* 40 mg/mL<br>* Other names: EGP-437;|
| Active Comparator: Prednisolone Acetate Ophthalmic (1%)<br>Prednisolone Acetate Ophthalmic (1%) | Drug: Prednisolone Acetate Ophthalmic (1%)<br>* Prednisolone Acetate (1%)<br>* Other names: Pred Acetate (1%);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with an AC cell count of zero at Day 14 |  | Day 14 ± 2 days | 

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