Safety and Efficacy Study of Iontophoresis and Dexamethasone Phosphate to Treat Anterior Uveitis

EyeGate Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Uveitis, Anterior

Treatments: Drug: EGP-437 10.0 mA-min at 2.5 mA with EyeGate® II System; Drug: EGP-437 1.6 mA-min at 0.4 with EyeGate® II System; Drug: EGP-437 4.8 mA-min at 1.2 mA with EyeGate® II System; Drug: EGP-437 14.0 mA-min at 3.5 mA with EyeGate® II System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00694135

EGP-437-001

Details and patient eligibility

About

The purpose of this study is to define a safe and effective dose of iontophoretic delivery of dexamethasone phosphate ophthalmic solution using the EyeGate® II Drug Delivery System in patients with non-infectious anterior segment uveitis.

Full description

This is a randomized, double-masked, parallel group, dose-comparison, exploratory study of four doses of iontophoretic delivery of dexamethasone phosphate ophthalmic solution in patients with non-infectious anterior segment uveitis. The current study will evaluate the safety, tolerability, and efficacy of this technology at the four dose levels to determine a safe effective dose appropriate for future trials.

Enrollment: 40 patients

Sex: All

Ages: 12 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Non-infectious anterior uveitis

Exclusion criteria

• Uveitis of infectious etiology
• Previous anterior uveitis episode ≤ 4 weeks prior to baseline
• Intraocular pressure (IOP) ≥ 25 mmHg at baseline, a history of glaucoma, and/or patients who require ocular anti-hypertensive medications
• Topical corticosteroid treatment in either eye < 48 hours prior to baseline
• Oral corticosteroid or intraorbital corticosteroid treatment in either eye < 2 weeks prior to baseline
• Active intermediate or posterior uveitis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 4 patient groups

EGP-437 1.6 mA-min at 0.4 mA

Active Comparator group

Description:

Ocular iontophoresis with EGP 437 1.6 mA-min at 0.4 mA

Treatment:

Drug: EGP-437 1.6 mA-min at 0.4 with EyeGate® II System

EGP-437 4.8 mA-min at 1.2 mA

Active Comparator group

Description:

Ocular iontophoresis with EGP-437 4.8 mA-min at 1.2 mA

Treatment:

Drug: EGP-437 4.8 mA-min at 1.2 mA with EyeGate® II System

EGP-437 10.0 mA-min at 2.5 mA

Active Comparator group

Description:

Ocular iontophoresis with EGP-437 10.0 mA-min at 2.5 mA

Treatment:

Drug: EGP-437 10.0 mA-min at 2.5 mA with EyeGate® II System

EGP-437 14.0 mA-min at 3.5 mA

Active Comparator group

Description:

Ocular iontophoresis with EGP-437 14.0 mA-min at 3.5 mA

Treatment:

Drug: EGP-437 14.0 mA-min at 3.5 mA with EyeGate® II System