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

• Sign: Corneal fluorescein staining after CAE exposure at Visit 5 [ Time Frame: Visit 5 (Day 7 ± 2 Days) ] [ Designated as safety issue: Yes ]
  Corneal fluorescein staining after CAE exposure at Visit 5 as measured by the ORA scale.
• Symptom: Ocular discomfort during CAE exposure at Visit 5 [ Time Frame: Visit 5 (Day 7 ± 2 Days) ] [ Designated as safety issue: Yes ]
  Symptom: Ocular discomfort during CAE exposure at Visit 5 as measured by ORA scale.

• Sign: Fluorescein staining at each visit over 3 weeks [ Time Frame: 7 visits / 3 weeks ] [ Designated as safety issue: Yes ]
  Fluorescein staining (each region) as measured by the ORA and NEI Scales at each of 7 visits over 3 weeks
• Symptom: Ocular discomfort pre and post CAE [ Time Frame: Visit 1 (Day -7 ± 2 Days), Visit 3 (Day 0), and Visit 5 (Day 7 ± 2 Days) ] [ Designated as safety issue: Yes ]
  Symptom: Ocular discomfort pre and post CAE (ORA Scale)at 3 visits (Visits 1, 3, and 5)

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.

• Drug: EGP-437 with EyeGate® II System
  Transscleral iontophoretic delivery of EGP-437 (dexamethasone phosphate ophthalmic solution 40 mg/mL) delivered via EyeGate® II Drug Delivery System
  Other Name: Dexamethasone phosphate ophthalmic solution
• Drug: Sodium citrate buffer solution with EyeGate® II System
  Transscleral iontophoretic delivery of sodium citrate buffer solution 100 mM delivered via EyeGate® II Drug Delivery System
  Other Name: Sodium citrate buffer solution

• Active Comparator: Low Dose: DP 7.5 mA-min at 2.5 mA
  Ocular Iontophoresis with EGP-437 (dexamethasone phosphate ophthalmic solution 40 mg/mL) 7.5 mA-min at 2.5 mA
  Intervention: Drug: EGP-437 with EyeGate® II System
• Active Comparator: High Dose: DP 10.5 mA-min at 3.5 mA
  Ocular Iontophoresis with EGP-437 (dexamethasone phosphate ophthalmic solution 40 mg/mL) 10.5 mA-min at 3.5 mA
  Intervention: Drug: EGP-437 with EyeGate® II System
• Placebo Comparator: Placebo: 10.5 mA-min at 3.5 mA
  Ocular Iontophoresis with Placebo (sodium citrate buffer solution 100 mM at 10.5 mA-min at 3.5 mA)
  Intervention: Drug: Sodium citrate buffer solution with EyeGate® II System

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