Safety and Efficacy Study of EGP-437 (Dexamethasone Phosphate Formulated for Ocular Iontophoresis) to Treat Dry Eye

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety and efficacy of EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis) using the EyeGate® II Iontophoresis system in patients with dry eye.

• Phase: Phase 3
• 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 at Visits 1 and 2

Exclusion Criteria:

• Have contraindications to the use of the test articles

• Have known allergy or sensitivity to the study medications or their components

• Have any ocular infections, active ocular inflammation, or preauricular lymphadenopathy

• Be current contact lens wearers or wear contacts during the study