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

EyeGate Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Dry Eye

Treatments: Drug: Dexamethasone phosphate ophthalmic solution; Drug: Sodium citrate buffer solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01129856

EGP-437-003

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 198 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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198 participants in 3 patient groups, including a placebo group

Ocular Iontophoresis EGP-437, Low Dose

Active Comparator group

Description:

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

Treatment:

Drug: Dexamethasone phosphate ophthalmic solution

Ocular Iontophoresis EGP-437, High Dose

Active Comparator group

Description:

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

Treatment:

Drug: Dexamethasone phosphate ophthalmic solution

Ocular Iontophoresis Placebo

Placebo Comparator group

Description:

Ocular Iontophoresis with Placebo 6.5 mA-min at 2.5 mA

Treatment:

Drug: Sodium citrate buffer solution