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

NCT ID: NCT00765804

Last Updated: 2010-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-02-28

Brief Summary

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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

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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.

Conditions

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Dry Eye Syndrome

Keywords

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Dry Eye Iontophoresis Ophthalmic Delivery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

EGP-437 with EyeGate® II System

Intervention Type DRUG

Transscleral iontophoretic delivery of EGP-437 (dexamethasone phosphate ophthalmic solution 40 mg/mL) delivered via EyeGate® II Drug Delivery System

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

Group Type ACTIVE_COMPARATOR

EGP-437 with EyeGate® II System

Intervention Type DRUG

Transscleral iontophoretic delivery of EGP-437 (dexamethasone phosphate ophthalmic solution 40 mg/mL) delivered via EyeGate® II Drug Delivery System

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)

Group Type PLACEBO_COMPARATOR

Sodium citrate buffer solution with EyeGate® II System

Intervention Type DRUG

Transscleral iontophoretic delivery of sodium citrate buffer solution 100 mM delivered via EyeGate® II Drug Delivery System

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Dexamethasone phosphate ophthalmic solution Sodium citrate buffer solution

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eyegate Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Eyegate Pharmaceuticals, Inc.

Principal Investigators

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Gail Torkildsen, MD

Role: PRINCIPAL_INVESTIGATOR

ORA, Inc.

Locations

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Ophthalmic Research Associates

Andover, Massachusetts, United States

Site Status

Ophthalmic Research Associates

North Andover, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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EGP-437-002

Identifier Type: -

Identifier Source: org_study_id