Overview

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