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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

251 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-16

Study Completion Date

2018-05-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anterior Uveitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dexamethasone Phosphate Ophthalmic Solution

Dexamethasone phosphate ophthalmic solution (40 mg/mL)

Group Type EXPERIMENTAL

Dexamethasone Phosphate Ophthalmic Solution

Intervention Type DRUG

40 mg/mL

Prednisolone Acetate Ophthalmic (1%)

Group Type ACTIVE_COMPARATOR

Prednisolone Acetate Ophthalmic (1%)

Intervention Type DRUG

Prednisolone Acetate (1%)

Interventions

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Dexamethasone Phosphate Ophthalmic Solution

40 mg/mL

Intervention Type DRUG

Prednisolone Acetate Ophthalmic (1%)

Prednisolone Acetate (1%)

Intervention Type DRUG

Other Intervention Names

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EGP-437 Pred Acetate (1%)

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No