Safety and Efficacy Study of EGP-437 (Dexamethasone Phosphate Formulated for Ocular Iontophoresis) to Treat Dry Eye

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and efficacy of EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis) using the EyeGate® II Iontophoresis system in patients with dry eye.

Detailed Description
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Dry eye is the most prevalent form of ocular discomfort and irritation. Estimates range from 20 million people in the United States being affected with mild to moderate dry eye, to as many as one out of every five Americans. EyeGate completed a single-center, randomized, double-masked, placebo-controlled Phase 2 efficacy study in 105 subjects with mild to moderate dry eye disease, utilizing the Controlled Adverse Environment (CAE), a clinical model which allows for standardized measurement of dry eye signs and symptoms in the investigation of therapeutic agents. In this Phase 2 study, the improvements documented in dry eye signs and symptoms relative to the placebo group indicated that the ocular iontophoresis treatments with EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis) had both a rapid onset of action and a long-term effectiveness. The Phase 3 study is intended to confirm and extend the results from the Phase 2 study, utilizing the CAE model. The study is designed to assess the safety and efficacy of EGP-437 at two different dose levels: Ocular Iontophoresis with EGP-437 4.0 mA-min at 1.5 mA and Ocular Iontophoresis with EGP-437 6.5 mA-min at 2.5 mA compared to Ocular Iontophoresis with placebo (sodium citrate buffer solution) for the treatment of the signs and symptoms of dry eye.

Official Title
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Evaluation of Dexamethasone Phosphate Delivered by Ocular Iontophoresis for the Treatment of Dry Eye in the Controlled Adverse Environment (CAE) Model

Conditions
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Dry Eye

Intervention / Treatment
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* Drug: Dexamethasone phosphate ophthalmic solution
* Drug: Sodium citrate buffer solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a reported history of dry eye in each eye Be at least 12 years of age Demonstrate a response when exposed to the Controlled Adverse Environment model at Visits 1 and 2 Exclusion Criteria: Have contraindications to the use of the test articles Have known allergy or sensitivity to the study medications or their components Have any ocular infections, active ocular inflammation, or preauricular lymphadenopathy Be current contact lens wearers or wear contacts during the study

Ages Eligible for Study
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Minimum Age: 12 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: Ocular Iontophoresis EGP-437, Low Dose<br>Ocular Iontophoresis with EGP-437 4.0 mA-min at 1.5 mA | Drug: Dexamethasone phosphate ophthalmic solution<br>* Transscleral iontophoresis delivery of EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis)<br>|
| Active Comparator: Ocular Iontophoresis EGP-437, High Dose<br>Ocular Iontophoresis with EGP-437 6.5 mA-min at 2.5 mA | Drug: Dexamethasone phosphate ophthalmic solution<br>* Transscleral iontophoresis delivery of EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis)<br>|
| Placebo Comparator: Ocular Iontophoresis Placebo<br>Ocular Iontophoresis with Placebo 6.5 mA-min at 2.5 mA | Drug: Sodium citrate buffer solution<br>* Sodium citrate buffer solution 100 mM<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sign: Differences in corneal fluorescein staining (inferior region, Ora Scale) Visit 1 Pre-CAE to Visit 6 compared to placebo; Symptom: Ocular discomfort at Visit 5 as compared to placebo |  | Up to 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sign: Corneal fluorescein staining (each region, Ora Scale); Symptom: Ocular discomfort pre- and post-CAE (Ora Scale) |  | Up to 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry eye, Keratoconjunctivitis sicca, Iontophoresis, Ophthalmic drug delivery, EGP-437, Dexamethasone phosphate