Safety and Efficacy Study of EGP-437 (Dexamethasone Phosphate Formulated for Ocular Iontophoresis) to Treat Dry Eye
- Conditions
- Dry Eye
- Interventions
- Drug: Sodium citrate buffer solution
- Registration Number
- NCT01129856
- Lead Sponsor
- Eyegate Pharmaceuticals, Inc.
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 198
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ocular Iontophoresis EGP-437, Low Dose Dexamethasone phosphate ophthalmic solution Ocular Iontophoresis with EGP-437 4.0 mA-min at 1.5 mA Ocular Iontophoresis EGP-437, High Dose Dexamethasone phosphate ophthalmic solution Ocular Iontophoresis with EGP-437 6.5 mA-min at 2.5 mA Ocular Iontophoresis Placebo Sodium citrate buffer solution Ocular Iontophoresis with Placebo 6.5 mA-min at 2.5 mA
- Primary Outcome Measures
Name Time Method 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
Name Time Method Sign: Corneal fluorescein staining (each region, Ora Scale); Symptom: Ocular discomfort pre- and post-CAE (Ora Scale) Up to 10 weeks
Trial Locations
- Locations (5)
Central Maine Eye Care
🇺🇸Lewiston, Maine, United States
Andover Eye Associates
🇺🇸Andover, Massachusetts, United States
The Eye Care Group
🇺🇸Waterbury, Connecticut, United States
Total Eye Care
🇺🇸Memphis, Tennessee, United States
Virginia Eye Consultants
🇺🇸Norfolk, Virginia, United States