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

Primary Purpose

Dry Eye Syndrome

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
EGP-437 with EyeGate® II System
Sodium citrate buffer solution with EyeGate® II System
Sponsored by
Eyegate Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndrome focused on measuring Dry Eye, Iontophoresis, Ophthalmic Delivery

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ophthalmic Research Associates
  • Ophthalmic Research Associates

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Low Dose: DP 7.5 mA-min at 2.5 mA

High Dose: DP 10.5 mA-min at 3.5 mA

Placebo: 10.5 mA-min at 3.5 mA

Arm Description

Ocular Iontophoresis with EGP-437 (dexamethasone phosphate ophthalmic solution 40 mg/mL) 7.5 mA-min at 2.5 mA

Ocular Iontophoresis with EGP-437 (dexamethasone phosphate ophthalmic solution 40 mg/mL) 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)

Outcomes

Primary Outcome Measures

Sign: Corneal fluorescein staining after CAE exposure at Visit 5
Corneal fluorescein staining after CAE exposure at Visit 5 as measured by the ORA scale.
Symptom: Ocular discomfort during CAE exposure at Visit 5
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
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
Symptom: Ocular discomfort pre and post CAE (ORA Scale)at 3 visits (Visits 1, 3, and 5)

Full Information

First Posted
October 2, 2008
Last Updated
August 27, 2010
Sponsor
Eyegate Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00765804
Brief Title
Safety and Efficacy Study of Iontophoresis and Dexamethasone Phosphate to Treat Dry Eye
Official Title
Evaluation of Dexamethasone Phosphate Delivered by Ocular Iontophoresis for Treatment of Dry Eye in the Controlled Adverse Environment Model
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eyegate Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndrome
Keywords
Dry Eye, Iontophoresis, Ophthalmic Delivery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Dose: DP 7.5 mA-min at 2.5 mA
Arm Type
Active Comparator
Arm Description
Ocular Iontophoresis with EGP-437 (dexamethasone phosphate ophthalmic solution 40 mg/mL) 7.5 mA-min at 2.5 mA
Arm Title
High Dose: DP 10.5 mA-min at 3.5 mA
Arm Type
Active Comparator
Arm Description
Ocular Iontophoresis with EGP-437 (dexamethasone phosphate ophthalmic solution 40 mg/mL) 10.5 mA-min at 3.5 mA
Arm Title
Placebo: 10.5 mA-min at 3.5 mA
Arm Type
Placebo Comparator
Arm Description
Ocular Iontophoresis with Placebo (sodium citrate buffer solution 100 mM at 10.5 mA-min at 3.5 mA)
Intervention Type
Drug
Intervention Name(s)
EGP-437 with EyeGate® II System
Other Intervention Name(s)
Dexamethasone phosphate ophthalmic solution
Intervention Description
Transscleral iontophoretic delivery of EGP-437 (dexamethasone phosphate ophthalmic solution 40 mg/mL) delivered via EyeGate® II Drug Delivery System
Intervention Type
Drug
Intervention Name(s)
Sodium citrate buffer solution with EyeGate® II System
Other Intervention Name(s)
Sodium citrate buffer solution
Intervention Description
Transscleral iontophoretic delivery of sodium citrate buffer solution 100 mM delivered via EyeGate® II Drug Delivery System
Primary Outcome Measure Information:
Title
Sign: Corneal fluorescein staining after CAE exposure at Visit 5
Description
Corneal fluorescein staining after CAE exposure at Visit 5 as measured by the ORA scale.
Time Frame
Visit 5 (Day 7 ± 2 Days)
Title
Symptom: Ocular discomfort during CAE exposure at Visit 5
Description
Symptom: Ocular discomfort during CAE exposure at Visit 5 as measured by ORA scale.
Time Frame
Visit 5 (Day 7 ± 2 Days)
Secondary Outcome Measure Information:
Title
Sign: Fluorescein staining at each visit over 3 weeks
Description
Fluorescein staining (each region) as measured by the ORA and NEI Scales at each of 7 visits over 3 weeks
Time Frame
7 visits / 3 weeks
Title
Symptom: Ocular discomfort pre and post CAE
Description
Symptom: Ocular discomfort pre and post CAE (ORA Scale)at 3 visits (Visits 1, 3, and 5)
Time Frame
Visit 1 (Day -7 ± 2 Days), Visit 3 (Day 0), and Visit 5 (Day 7 ± 2 Days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gail Torkildsen, MD
Organizational Affiliation
ORA, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ophthalmic Research Associates
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
Facility Name
Ophthalmic Research Associates
City
North Andover
State/Province
Massachusetts
ZIP/Postal Code
01845
Country
United States

12. IPD Sharing Statement

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

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