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Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution in Non-Infectious Anterior Uveitis

NCT02517619 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 251

Last updated 2018-07-26

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

Dexamethasone Phosphate Ophthalmic Solution

40 mg/mL

DRUG

Prednisolone Acetate Ophthalmic (1%)

Prednisolone Acetate (1%)

Sponsors & Collaborators

  • Eyegate Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • John D. Sheppard, M.D. · Study Principal Investigator

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
2016-01-16
Primary Completion
2018-04-20
Completion
2018-05-29

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 NCT02517619 on ClinicalTrials.gov