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

This study has been completed.
Sponsor:
Information provided by:
Eyegate Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00765804
First received: October 2, 2008
Last updated: August 27, 2010
Last verified: August 2010
  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
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 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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
    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

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

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
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: 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

No publications provided

Responsible Party: Stephen From/Chief Executive Officer, Eyegate Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00765804     History of Changes
Other Study ID Numbers: EGP-437-002
Study First Received: October 2, 2008
Last Updated: August 27, 2010
Health Authority: United States: Food and Drug Administration

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
Ophthalmic Solutions
Citric Acid
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 16, 2014