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Safety and Efficacy Study of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution to Treat Non-Infectious Anterior Segment Uveitis

NCT01505088 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 193

Last updated 2013-03-29

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and efficacy of ocular iontophoresis with dexamethasone phosphate ophthalmic solution EGP-437 using the EyeGate® II Drug Delivery System (EGDS) compared to prednisolone acetate ophthalmic suspension (1%) in patients with non-infectious anterior segment uveitis.

Conditions

  • Anterior Uveitis

Interventions

DRUG

40 mg/mL Dexamethasone phosphate ophthalmic solution

Transscleral iontophoresis delivery of EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis)

DRUG

Prednisolone Acetate (1%) Eyedrops

Prednisolone acetate (1%) eyedrops

DRUG

100 mM sodium citrate buffer solution

Transscleral iontophoresis delivery of 100 mM Sodium citrate buffer solution

DRUG

Placebo Eyedrops

Placebo Eyedrops

Sponsors & Collaborators

  • Eyegate Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • John D. Sheppard, M.D. · Virginia Eye Consultants

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-02-28
Completion
2013-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01505088 on ClinicalTrials.gov