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

Sponsor

Eyegate Pharmaceuticals, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01129856

Collaborator

(none)

198

Enrollment

Locations

Arms

Duration (Months)

39.6

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye	Drug: Dexamethasone phosphate ophthalmic solution Drug: Sodium citrate buffer solution	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

198 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2010

Actual Primary Completion Date :

Jan 1, 2011

Actual Study Completion Date :

Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ocular Iontophoresis EGP-437, Low Dose Ocular Iontophoresis with EGP-437 4.0 mA-min at 1.5 mA	Drug: Dexamethasone phosphate ophthalmic solution Transscleral iontophoresis delivery of EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis)
Active Comparator: Ocular Iontophoresis EGP-437, High Dose Ocular Iontophoresis with EGP-437 6.5 mA-min at 2.5 mA	Drug: Dexamethasone phosphate ophthalmic solution Transscleral iontophoresis delivery of EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis)
Placebo Comparator: Ocular Iontophoresis Placebo Ocular Iontophoresis with Placebo 6.5 mA-min at 2.5 mA	Drug: Sodium citrate buffer solution Sodium citrate buffer solution 100 mM

Arm

Intervention/Treatment

Active Comparator: Ocular Iontophoresis EGP-437, Low Dose

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

Drug: Dexamethasone phosphate ophthalmic solution

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

Active Comparator: Ocular Iontophoresis EGP-437, High Dose

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

Drug: Dexamethasone phosphate ophthalmic solution

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

Placebo Comparator: Ocular Iontophoresis Placebo

Ocular Iontophoresis with Placebo 6.5 mA-min at 2.5 mA

Drug: Sodium citrate buffer solution

Sodium citrate buffer solution 100 mM

Outcome Measures

Primary Outcome Measures

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

Sign: Corneal fluorescein staining (each region, Ora Scale); Symptom: Ocular discomfort pre- and post-CAE (Ora Scale) [Up to 10 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Eye Care Group	Waterbury	Connecticut	United States	06708
2	Central Maine Eye Care	Lewiston	Maine	United States	04240
3	Andover Eye Associates	Andover	Massachusetts	United States	01810
4	Total Eye Care	Memphis	Tennessee	United States	38119
5	Virginia Eye Consultants	Norfolk	Virginia	United States	23502