Norfolk, Virginia 23502


Purpose:

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 summary:

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.


Criteria:

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:


NCT ID:

NCT02517619


Primary Contact:

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

Lisa Brandano
Email: lbrandano@eyegatepharma.com


Backup Contact:

Email: cassang@eyegatepharma.com
Carol Assang


Location Contact:

Norfolk, Virginia 23502
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 20, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.