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

Sponsor

Eyegate Pharmaceuticals, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00765804

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

44.5

Patients Per Site

Patients Per Site Per Month

Study Details

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.

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

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

89 participants

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

Study Start Date :

Oct 1, 2008

Actual Primary Completion Date :

Feb 1, 2009

Actual Study Completion Date :

Feb 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: 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 Names: Sodium citrate buffer solution

Arm

Intervention/Treatment

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 Names:

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 Names:

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 Names:

Sodium citrate buffer solution

Outcome Measures

Primary Outcome Measures

Sign: Corneal fluorescein staining after CAE exposure at Visit 5 [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 [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 [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 [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts 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