Clinical trial NCT01129856: Safety and Efficacy Study of EGP-437 (Dexamethasone Phosphate Formulated for Ocular Iontophoresis) to Treat Dry Eye
Official title: Evaluation of Dexamethasone Phosphate Delivered by Ocular Iontophoresis for the Treatment of Dry Eye in the Controlled Adverse Environment (CAE) Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye
Keywords: Dry eye
Keratoconjunctivitis sicca
Iontophoresis
Ophthalmic drug delivery
EGP-437
Dexamethasone phosphate
Lead sponsor: Eyegate Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2010-05-25
Enrollment: 198
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Up to 10 weeks
Secondary outcomes:
measure: Sign: Corneal fluorescein staining (each region, Ora Scale); Symptom: Ocular discomfort pre- and post-CAE (Ora Scale)
timeFrame: Up to 10 weeks
Other outcomes:
Locations:
city: Waterbury
country: United States
facility: The Eye Care Group
state: Connecticut
city: Lewiston
country: United States
facility: Central Maine Eye Care
state: Maine
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
city: Memphis
country: United States
facility: Total Eye Care
state: Tennessee
city: Norfolk
country: United States
facility: Virginia Eye Consultants
state: Virginia
Study officials:
affiliation: Andover Eye Associates
name: Gail L Torkildsen, MD
role: PRINCIPAL_INVESTIGATOR
References: