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

This study has been completed.
Sponsor:
Information provided by:
Eyegate Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01129856
First received: May 20, 2010
Last updated: April 25, 2011
Last verified: April 2011
  Purpose

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 Intervention Phase
Dry Eye
Drug: Dexamethasone phosphate ophthalmic solution
Drug: Sodium citrate buffer solution
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Eyegate Pharmaceuticals, Inc.:

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 [ Time Frame: Up to 10 weeks ] [ Designated as safety issue: Yes ]

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

Enrollment: 198
Study Start Date: June 2010
Study Completion Date: April 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01129856

Locations
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
Principal Investigator: Gail L Torkildsen, MD Andover Eye Associates
  More Information

No publications provided

Responsible Party: Stephen From / President and Chief Executive Officer, Eyegate Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01129856     History of Changes
Other Study ID Numbers: EGP-437-003
Study First Received: May 20, 2010
Last Updated: April 25, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Eyegate Pharmaceuticals, Inc.:
Dry eye
Keratoconjunctivitis sicca
Iontophoresis
Ophthalmic drug delivery
EGP-437
Dexamethasone phosphate

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Citric Acid
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Ophthalmic Solutions
Pharmaceutical Solutions
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on August 21, 2014