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

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eyegate Pharmaceuticals, Inc.
• Treatments: BB 1101; Citric Acid; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Ophthalmic Solutions; Pharmaceutical Solutions; Sodium Citrate

Criteria

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