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Completed

NCT Number: NCT00694135

Safety and Efficacy Study of Iontophoresis and Dexamethasone Phosphate to Treat Anterior Uveitis

The purpose of this study is to define a safe and effective dose of iontophoretic delivery of dexamethasone phosphate ophthalmic solution using the EyeGate® II Drug Delivery System in patients with non-infectious anterior segment uveitis.

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Key information

Conditions

Uveitis, Anterior Eye Diseases Panuveitis Uveal Diseases Uveitis

Age range

12 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Narayana Nethralaya, Bangalore, Karnataka, India

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About this study

This is a randomized, double-masked, parallel group, dose-comparison, exploratory study of four doses of iontophoretic delivery of dexamethasone phosphate ophthalmic solution in patients with non-infectious anterior segment uveitis. The current study will evaluate the safety, tolerability, and efficacy of this technology at the four dose levels to determine a safe effective dose appropriate for future trials.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Non-infectious anterior uveitis

Exclusion criteria

  • Uveitis of infectious etiology
  • Previous anterior uveitis episode ≤ 4 weeks prior to baseline
  • Intraocular pressure (IOP) ≥ 25 mmHg at baseline, a history of glaucoma, and/or patients who require ocular anti-hypertensive medications
  • Topical corticosteroid treatment in either eye < 48 hours prior to baseline
  • Oral corticosteroid or intraorbital corticosteroid treatment in either eye < 2 weeks prior to baseline
  • Active intermediate or posterior uveitis

Treatment and study plan

EGP-437 1.6 mA-min at 0.4 with EyeGate® II System

Drug

Ocular Iontophoresis with EGP-437 1.6 mA-min at 0.4 mA delivered via EyeGate® II Drug Delivery System

Other names: Dexamethasone Phosphate Ophthalmic Solution

EGP-437 4.8 mA-min at 1.2 mA with EyeGate® II System

Drug

Ocular Iontophoresis with EGP-437 4.8 mA-min at 1.2 mA delivered via EyeGate® II Drug Delivery System

Other names: Dexamethasone Phosphate Ophthalmic Solution

EGP-437 10.0 mA-min at 2.5 mA with EyeGate® II System

Drug

Ocular Iontophoresis with EGP-437 10.0 mA-min at 2.5 mA delivered via EyeGate® II Drug Delivery System

Other names: Dexamethasone Phosphate Ophthalmic Solution

EGP-437 14.0 mA-min at 3.5 mA with EyeGate® II System

Drug

Ocular Iontophoresis with EGP-437 14.0 mA-min at 3.5 mA delivered via EyeGate® II Drug Delivery System

Other names: Dexamethasone Phosphate Ophthalmic Solution

Primary outcomes

  1. Proportion of subjects with an ACC score of zero at Days 14 and 28

    Time frame: Prospective study, subjects followed for 28 days

    Proportion of subjects with an anterior chamber cell (ACC) score of zero at Days 14 and 28

Secondary outcomes

  1. Time to ACC score of zero

    Time frame: Prospective study, subjects followed for 28 days

    Time to anterior chamber cell score of zero

  2. Proportion of subjects with a reduction of one full ACC score or more from baseline at Day 28

    Time frame: Prospective study, subjects followed for 28 days

    Proportion of subjects with a reduction of one full anterior chamber cell score or more (≥ 0.5 decrease) from baseline at Day 28

  3. Change from baseline in ACC score at Day 28

    Time frame: Prospective study, subjects followed for 28 days

    Change from baseline in anterior chamber cell score at Day 28

  4. Treatment emergent adverse events

    Time frame: Prospective study, subjects followed for 28 days

    Treatment emergent adverse events

Sponsors and collaborators

Lead sponsor

Eyegate Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Prospective, Multi-Center, Randomized, Double-Masked, Safety, Tolerability and Efficacy Study of Four Iontophoretic Doses of Dexamethasone Phosphate Ophthalmic Solution in Patients With Non-Infectious Anterior Segment Uveitis

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 10, 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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