Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution in Non-Infectious Anterior Uveitis (EGP-437-006)

July 24, 2018 updated by: Eyegate Pharmaceuticals, Inc.

A Prospective, Multi-Center, Randomized, Double-Masked, Positive Controlled, Phase 3 Clinical Trial Designed to Evaluate the Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution Compared to Prednisolone Acetate Ophthalmic Suspension (1%) in Patients With Non-Infectious Anterior Segment Uveitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This will be a Phase 3, randomized, double-masked, parallel arm, positive-controlled non-inferiority study, in which up to 250 subjects (approximately 125 subjects per treatment arm) will be enrolled at up to 60 clinical sites. Patients with non-infectious anterior segment uveitis who are interested in participating in the study will be provided an informed consent form prior to screening. Screening/Baseline procedures which include BCVA, slit lamp examination, fundus exam, IOP by tonometry will be used to determine eligibility.

Study Type

Interventional

Enrollment (Actual)

251

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Virginia Eye Consultants

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 85 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 12 to 85 years with a diagnosis of non-infectious anterior segment uveitis defined as an AC cell count of ≥ 11 cells
  2. Receive, understand, and sign a copy of the written informed consent form
  3. Be able to return for all study visits and willing to comply with all study-related instructions

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Dexamethasone Phosphate Ophthalmic Solution
Dexamethasone phosphate ophthalmic solution (40 mg/mL)
Drug: Dexamethasone Phosphate Ophthalmic Solution
40 mg/mL
Other Names:
  • EGP-437
ACTIVE_COMPARATOR: Prednisolone Acetate Ophthalmic (1%)
Drug: Prednisolone Acetate Ophthalmic (1%)
Prednisolone Acetate (1%)
Other Names:
  • Pred Acetate (1%)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects with an AC cell count of zero at Day 14
Time Frame: Day 14 ± 2 days
Day 14 ± 2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eyegate Pharmaceuticals, Inc.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 16, 2016

Primary Completion (ACTUAL)

April 20, 2018

Study Completion (ACTUAL)

May 29, 2018

Study Registration Dates

First Submitted

August 5, 2015

First Submitted That Met QC Criteria

August 5, 2015

First Posted (ESTIMATE)

August 7, 2015

Study Record Updates

Last Update Posted (ACTUAL)

July 26, 2018

Last Update Submitted That Met QC Criteria

July 24, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EGP-437-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anterior Uveitis

Clinical Trials on Dexamethasone Phosphate Ophthalmic Solution

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe