Iontophoresis Delivery of Dexamethasone Phosphate for Non-infectious, Non-necrotizing Anterior Scleritis, Phase 1 Dose-varying Study
The Iontophoresis Delivery of Dexamethasone Phosphate for Non-infectious, Non-necrotizing Anterior Scleritis, Phase 1 Dose-varying Study (Scleritis Study) is a randomized clinical trial designed to evaluate the safety and provide a preliminary assessment of the effectiveness of a new drug used with a new drug delivery system to treat patients with anterior scleritis.
The sponsors of this study are the United States Food and Drug Administration (FDA), which is an agency that is part of the federal government, and EyeGate Pharmaceuticals, Inc. (EyeGate), the distributor/manufacturer of the product being studied.
What is Anterior Scleritis and Why is this study Important?
Scleritis is an inflammation (soreness and redness) in the front part of the eye that is usually severely painful, and is potentially blinding. Management of scleritis typically involves a "stepladder" approach, beginning with oral non-steroidal anti-inflammatory (NSAID) drugs, progressing to oral corticosteroids and immunosuppressive agents for severe disease. Such systemic treatments are, unfortunately, associated with a risk of unpleasant and/or serious side effects. Therefore, development of a safe and effective locally delivered therapy is important because it may alter the way in which scleritis is treated, and could potentially save vision, reduce side effects, and lower the cost and complexity of therapy.
Study Drug, Delivery System, and Study Design:
This study will evaluate treatment of scleritis using a study drug called Dexamethasone Phosphate and a new iontophoretic drug delivery system proprietary to EyeGate. The delivery system consists of an applicator containing the study drug that is placed on the eye, a generator that produces a small amount of electricity to move the study drug from the applicator into the eye, and a return electrode that lets the electricity move between the generator and applicator.
About 18-24 people will take part in this study at up to 6 clinical centers in the US. The subjects in the study will be randomly assigned to receive either one treatment with the study drug, followed by a second treatment with the drug a week later; or to receive treatment with the study drug followed by a treatment with a placebo (no active drug) a week later. This study will be conducted in steps to evaluate a range of ocular iontophoresis doses. The treatments will be given at one of three increasing levels of iontophoretic current to assess the safety, tolerability, and efficacy of each dose. Each of the subjects will complete 8 study visits over a 56 day period.
CPOB's Role in the Scleritis Study:
The CPOB serves as the Coordinating Center for this study, and John H. Kempen, MD, PhD is the Sponsor-Investigator.
For more information on the Scleritis Trial, please contact Kathy McWilliams.