Safety and Efficacy Study of Iontophoresis and Dexamethasone Phosphate to Treat Dry Eye

Evaluation of Dexamethasone Phosphate Delivered by Ocular Iontophoresis for Treatment of Dry Eye in the Controlled Adverse Environment Model

The purpose of this study is to assess the safety and efficacy of iontophoretic delivery of dexamethasone phosphate ophthalmic solution using the EyeGate® II Drug Delivery System in patients with dry eye.

The objective of this study is to assess the safety and efficacy of Ocular Iontophoresis with Dexamethasone Phosphate 40 mg/mL 7.5 mA-min at 2.5 mA and Ocular Iontophoresis with Dexamethasone Phosphate 40 mg/mL 10.5 mA-min at 3.5 mA compared to placebo for the treatment of the signs and symptoms of dry eye.

Inclusion Criteria:

• Have a reported history of dry eye in each eye
• Be at least 12 years of age
• Demonstrate a response when exposed to the Controlled Adverse Environment model

Exclusion Criteria:

• Have contraindications to the use of the test articles
• Have known allergy or sensitivity to the study medication or their components (including corticosteroids)
• Have any ocular infections, active ocular inflammation or preauricular lymphadenopathy
• Be current contact lens wearers or wear contacts during the study