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

EyeGate Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Anterior Uveitis

Treatments: Drug: Prednisolone Acetate Ophthalmic (1%); Drug: Dexamethasone Phosphate Ophthalmic Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT02517619

EGP-437-006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 251 patients

Sex: All

Ages: 12 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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:

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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251 participants in 2 patient groups

Dexamethasone Phosphate Ophthalmic Solution

Experimental group

Description:

Dexamethasone phosphate ophthalmic solution (40 mg/mL)

Treatment:

Drug: Dexamethasone Phosphate Ophthalmic Solution

Prednisolone Acetate Ophthalmic (1%)

Active Comparator group

Description:

Prednisolone Acetate Ophthalmic (1%)

Treatment:

Drug: Prednisolone Acetate Ophthalmic (1%)