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Safety and Efficacy Study of Iontophoresis and Dexamethasone Phosphate to Treat Dry Eye

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00765804
First Posted: October 3, 2008
Last Update Posted: August 31, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Eyegate Pharmaceuticals, Inc.
  Purpose
The purpose of this study is to assess the safety and efficacy of iontophoretic delivery of dexamethasone phosphate ophthalmic solution using the EyeGate® II Drug Delivery System in patients with dry eye.

Condition Intervention Phase
Dry Eye Syndrome Drug: EGP-437 with EyeGate® II System Drug: Sodium citrate buffer solution with EyeGate® II System Phase 2

Study Type: Interventional
Study Design: 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 Treatment of Dry Eye in the Controlled Adverse Environment Model

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Sign: Corneal fluorescein staining after CAE exposure at Visit 5 [ Time Frame: Visit 5 (Day 7 ± 2 Days) ]
    Corneal fluorescein staining after CAE exposure at Visit 5 as measured by the ORA scale.

  • Symptom: Ocular discomfort during CAE exposure at Visit 5 [ Time Frame: Visit 5 (Day 7 ± 2 Days) ]
    Symptom: Ocular discomfort during CAE exposure at Visit 5 as measured by ORA scale.


Secondary Outcome Measures:
  • Sign: Fluorescein staining at each visit over 3 weeks [ Time Frame: 7 visits / 3 weeks ]
    Fluorescein staining (each region) as measured by the ORA and NEI Scales at each of 7 visits over 3 weeks

  • Symptom: Ocular discomfort pre and post CAE [ Time Frame: Visit 1 (Day -7 ± 2 Days), Visit 3 (Day 0), and Visit 5 (Day 7 ± 2 Days) ]
    Symptom: Ocular discomfort pre and post CAE (ORA Scale)at 3 visits (Visits 1, 3, and 5)


Enrollment: 89
Study Start Date: October 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Low Dose: DP 7.5 mA-min at 2.5 mA
Ocular Iontophoresis with EGP-437 (dexamethasone phosphate ophthalmic solution 40 mg/mL) 7.5 mA-min at 2.5 mA
Drug: EGP-437 with EyeGate® II System
Transscleral iontophoretic delivery of EGP-437 (dexamethasone phosphate ophthalmic solution 40 mg/mL) delivered via EyeGate® II Drug Delivery System
Other Name: Dexamethasone phosphate ophthalmic solution
Active Comparator: High Dose: DP 10.5 mA-min at 3.5 mA
Ocular Iontophoresis with EGP-437 (dexamethasone phosphate ophthalmic solution 40 mg/mL) 10.5 mA-min at 3.5 mA
Drug: EGP-437 with EyeGate® II System
Transscleral iontophoretic delivery of EGP-437 (dexamethasone phosphate ophthalmic solution 40 mg/mL) delivered via EyeGate® II Drug Delivery System
Other Name: Dexamethasone phosphate ophthalmic solution
Placebo Comparator: Placebo: 10.5 mA-min at 3.5 mA
Ocular Iontophoresis with Placebo (sodium citrate buffer solution 100 mM at 10.5 mA-min at 3.5 mA)
Drug: Sodium citrate buffer solution with EyeGate® II System
Transscleral iontophoretic delivery of sodium citrate buffer solution 100 mM delivered via EyeGate® II Drug Delivery System
Other Name: Sodium citrate buffer solution

Detailed Description:
The objective of this study is to assess the safety and efficacy of Ocular Iontophoresis with Dexamethasone Phosphate 40 mg/mL 7.5 mA-min at 2.5 mA and Ocular Iontophoresis with Dexamethasone Phosphate 40 mg/mL 10.5 mA-min at 3.5 mA compared to placebo for the treatment of the signs and symptoms of dry eye.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
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

Exclusion Criteria:

  • Have contraindications to the use of the test articles
  • Have known allergy or sensitivity to the study medication or their components (including corticosteroids)
  • Have any ocular infections, active ocular inflammation or preauricular lymphadenopathy
  • Be current contact lens wearers or wear contacts during the study
  Contacts and Locations
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): NCT00765804


Locations
United States, Massachusetts
Ophthalmic Research Associates
Andover, Massachusetts, United States, 01810
Ophthalmic Research Associates
North Andover, Massachusetts, United States, 01845
Sponsors and Collaborators
Eyegate Pharmaceuticals, Inc.
Investigators
Principal Investigator: Gail Torkildsen, MD ORA, Inc.
  More Information

Responsible Party: Stephen From/Chief Executive Officer, Eyegate Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00765804     History of Changes
Other Study ID Numbers: EGP-437-002
First Submitted: October 2, 2008
First Posted: October 3, 2008
Last Update Posted: August 31, 2010
Last Verified: August 2010

Keywords provided by Eyegate Pharmaceuticals, Inc.:
Dry Eye
Iontophoresis
Ophthalmic Delivery

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Pharmaceutical Solutions
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Citric Acid
Ophthalmic Solutions
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
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action