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

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ClinicalTrials.gov Identifier: NCT01129856
Recruitment Status : Completed
First Posted : May 25, 2010
Last Update Posted : April 27, 2011
Sponsor:
Information provided by:
Eyegate Pharmaceuticals, Inc.

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : June 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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 [ Time Frame: Up to 10 weeks ]

Secondary Outcome Measures :
  1. Sign: Corneal fluorescein staining (each region, Ora Scale); Symptom: Ocular discomfort pre- and post-CAE (Ora Scale) [ Time Frame: Up to 10 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01129856


Locations
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United States, Connecticut
The Eye Care Group
Waterbury, Connecticut, United States, 06708
United States, Maine
Central Maine Eye Care
Lewiston, Maine, United States, 04240
United States, Massachusetts
Andover Eye Associates
Andover, Massachusetts, United States, 01810
United States, Tennessee
Total Eye Care
Memphis, Tennessee, United States, 38119
United States, Virginia
Virginia Eye Consultants
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Eyegate Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Gail L Torkildsen, MD Andover Eye Associates
More Information
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Responsible Party: Stephen From / President and Chief Executive Officer, Eyegate Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01129856    
Other Study ID Numbers: EGP-437-003
First Posted: May 25, 2010    Key Record Dates
Last Update Posted: April 27, 2011
Last Verified: April 2011
Keywords provided by Eyegate Pharmaceuticals, Inc.:
Dry eye
Keratoconjunctivitis sicca
Iontophoresis
 Ophthalmic drug delivery
EGP-437
Dexamethasone phosphate
Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Dexamethasone
Citric Acid
Sodium Citrate
Pharmaceutical Solutions
Ophthalmic Solutions
Dexamethasone 21-phosphate
 Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents