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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-04-30

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.

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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.

Conditions

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Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ocular Iontophoresis EGP-437, Low Dose

Ocular Iontophoresis with EGP-437 4.0 mA-min at 1.5 mA

Group Type ACTIVE_COMPARATOR

Dexamethasone phosphate ophthalmic solution

Intervention Type DRUG

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

Ocular Iontophoresis EGP-437, High Dose

Ocular Iontophoresis with EGP-437 6.5 mA-min at 2.5 mA

Group Type ACTIVE_COMPARATOR

Dexamethasone phosphate ophthalmic solution

Intervention Type DRUG

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

Ocular Iontophoresis Placebo

Ocular Iontophoresis with Placebo 6.5 mA-min at 2.5 mA

Group Type PLACEBO_COMPARATOR

Sodium citrate buffer solution

Intervention Type DRUG

Sodium citrate buffer solution 100 mM

Interventions

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Dexamethasone phosphate ophthalmic solution

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

Intervention Type DRUG

Sodium citrate buffer solution

Sodium citrate buffer solution 100 mM

Intervention Type DRUG

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

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No