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

Phase 3

Completed

• Conditions: Anterior Uveitis
• Interventions: Drug: Dexamethasone Phosphate Ophthalmic Solution; Drug: Prednisolone Acetate Ophthalmic (1%)

• Registration Number: NCT02517619
• Lead Sponsor: Eyegate Pharmaceuticals, Inc.

Brief 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.

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 Timeline

• Study First Submitted: 2015-08-05
• Study First Submitted QC: 2015-08-05
• Study First Posted: 2015-08-07
• Study Start: 2016-01-16
• Primary Completion: 2018-04-20
• Study Completion: 2018-05-29
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-24
• Last Update Posted: 2018-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 251

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

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamethasone Phosphate Ophthalmic Solution	Dexamethasone Phosphate Ophthalmic Solution	Dexamethasone phosphate ophthalmic solution (40 mg/mL)
Prednisolone Acetate Ophthalmic (1%)	Prednisolone Acetate Ophthalmic (1%)	Prednisolone Acetate Ophthalmic (1%)

Primary Outcome Measures

Name	Time	Method
Proportion of subjects with an AC cell count of zero at Day 14	Day 14 ± 2 days

Trial Locations

Locations (1)

Virginia Eye Consultants; 🇺🇸 Norfolk, Virginia, United States