Safety and Efficacy Study of Iontophoresis and Dexamethasone Phosphate 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 iontophoretic delivery of dexamethasone phosphate ophthalmic solution using the EyeGate® II Drug Delivery System in patients with dry eye.

Detailed Description
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The objective of this study is to assess the safety and efficacy of Ocular Iontophoresis with Dexamethasone Phosphate 40 mg/mL 7.5 mA-min at 2.5 mA and Ocular Iontophoresis with Dexamethasone Phosphate 40 mg/mL 10.5 mA-min at 3.5 mA compared to placebo 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 Treatment of Dry Eye in the Controlled Adverse Environment Model

Conditions
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Dry Eye Syndrome

Intervention / Treatment
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* Drug: EGP-437 with EyeGate® II System
* Drug: Sodium citrate buffer solution with EyeGate® II System


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 Exclusion Criteria: Have contraindications to the use of the test articles Have known allergy or sensitivity to the study medication or their components (including corticosteroids) 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: Low Dose: DP 7.5 mA-min at 2.5 mA<br>Ocular Iontophoresis with EGP-437 (dexamethasone phosphate ophthalmic solution 40 mg/mL) 7.5 mA-min at 2.5 mA | Drug: EGP-437 with EyeGate® II System<br>* Transscleral iontophoretic delivery of EGP-437 (dexamethasone phosphate ophthalmic solution 40 mg/mL) delivered via EyeGate® II Drug Delivery System<br>* Other names: Dexamethasone phosphate ophthalmic solution;|
| Active Comparator: High Dose: DP 10.5 mA-min at 3.5 mA<br>Ocular Iontophoresis with EGP-437 (dexamethasone phosphate ophthalmic solution 40 mg/mL) 10.5 mA-min at 3.5 mA | Drug: EGP-437 with EyeGate® II System<br>* Transscleral iontophoretic delivery of EGP-437 (dexamethasone phosphate ophthalmic solution 40 mg/mL) delivered via EyeGate® II Drug Delivery System<br>* Other names: Dexamethasone phosphate ophthalmic solution;|
| Placebo Comparator: Placebo: 10.5 mA-min at 3.5 mA<br>Ocular Iontophoresis with Placebo (sodium citrate buffer solution 100 mM at 10.5 mA-min at 3.5 mA) | Drug: Sodium citrate buffer solution with EyeGate® II System<br>* Transscleral iontophoretic delivery of sodium citrate buffer solution 100 mM delivered via EyeGate® II Drug Delivery System<br>* Other names: Sodium citrate buffer solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sign: Corneal fluorescein staining after CAE exposure at Visit 5 | Corneal fluorescein staining after CAE exposure at Visit 5 as measured by the ORA scale. | Visit 5 (Day 7 ± 2 Days) | 
| Symptom: Ocular discomfort during CAE exposure at Visit 5 | Symptom: Ocular discomfort during CAE exposure at Visit 5 as measured by ORA scale. | Visit 5 (Day 7 ± 2 Days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sign: Fluorescein staining at each visit over 3 weeks | Fluorescein staining (each region) as measured by the ORA and NEI Scales at each of 7 visits over 3 weeks | 7 visits / 3 weeks | 
| Symptom: Ocular discomfort pre and post CAE | Symptom: Ocular discomfort pre and post CAE (ORA Scale)at 3 visits (Visits 1, 3, and 5) | Visit 1 (Day -7 ± 2 Days), Visit 3 (Day 0), and Visit 5 (Day 7 ± 2 Days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry Eye, Iontophoresis, Ophthalmic Delivery