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Completed

NCT Number: NCT00765804

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

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.

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Key information

Conditions

Dry Eye Syndrome Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ophthalmic Research Associates, Andover, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EGP-437 with EyeGate® II System

Drug

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

Sodium citrate buffer solution with EyeGate® II System

Drug

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

Other names: Sodium citrate buffer solution

Primary outcomes

  1. Sign: Corneal fluorescein staining after CAE exposure at Visit 5

    Time frame: Visit 5 (Day 7 ± 2 Days)

    Corneal fluorescein staining after CAE exposure at Visit 5 as measured by the ORA scale.

  2. Symptom: Ocular discomfort during CAE exposure at Visit 5

    Time frame: Visit 5 (Day 7 ± 2 Days)

    Symptom: Ocular discomfort during CAE exposure at Visit 5 as measured by ORA scale.

Secondary outcomes

  1. Sign: Fluorescein staining at each visit over 3 weeks

    Time frame: 7 visits / 3 weeks

    Fluorescein staining (each region) as measured by the ORA and NEI Scales at each of 7 visits over 3 weeks

  2. 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)

    Symptom: Ocular discomfort pre and post CAE (ORA Scale)at 3 visits (Visits 1, 3, and 5)

Sponsors and collaborators

Lead sponsor

Eyegate Pharmaceuticals, Inc.

Industry

Registry information

Official study title

Evaluation of Dexamethasone Phosphate Delivered by Ocular Iontophoresis for Treatment of Dry Eye in the Controlled Adverse Environment Model

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 3, 2008
Registry last updated
Aug 31, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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