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

Anterior Uveitis Clinical Trial

— EGP-437-006  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02517619
• Other study ID #: EGP-437-006
• Status: Completed
• Phase: Phase 3
• Start date: January 16, 2016
• Est. completion date: May 29, 2018

Study information

• Verified date: July 2018
• Source: Eyegate Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: May 29, 2018
• Est. primary completion date: April 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 85 Years

Eligibility

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:

Related Conditions & MeSH terms

• Anterior Uveitis
• Iridocyclitis
• Uveitis
• Uveitis, Anterior

Intervention

Drug:
• Dexamethasone Phosphate Ophthalmic Solution
40 mg/mL
• Prednisolone Acetate Ophthalmic (1%)
Prednisolone Acetate (1%)

Locations

Country	Name	City	State
United States	Virginia Eye Consultants	Norfolk	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Eyegate Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects with an AC cell count of zero at Day 14		Day 14 ± 2 days