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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

October 2, 2008
August 27, 2010
October 2008
February 2009   (final data collection date for primary outcome measure)
  • 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.
Sign: Corneal fluorescein staining after CAE exposure, Symptom: Ocular discomfort during CAE exposure [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00765804 on ClinicalTrials.gov Archive Site
  • 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)
Signs: Fluorescein staining, Symptoms: Ocular discomfort pre and post chamber [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Safety and Efficacy Study of Iontophoresis and Dexamethasone Phosphate to Treat Dry Eye
Evaluation of Dexamethasone Phosphate Delivered by Ocular Iontophoresis for Treatment of Dry Eye in the Controlled Adverse Environment Model

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Dry Eye Syndrome
  • 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
  • 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
  • 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
    Intervention: Drug: EGP-437 with EyeGate® II System
  • 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
    Intervention: Drug: EGP-437 with EyeGate® II System
  • 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)
    Intervention: Drug: Sodium citrate buffer solution with EyeGate® II System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
89
February 2009
February 2009   (final data collection date for primary outcome measure)

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
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00765804
EGP-437-002
No
Stephen From/Chief Executive Officer, Eyegate Pharmaceuticals, Inc.
Eyegate Pharmaceuticals, Inc.
Not Provided
Principal Investigator: Gail Torkildsen, MD ORA, Inc.
Eyegate Pharmaceuticals, Inc.
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP