Status:
COMPLETED
Safety and Efficacy Study of Iontophoresis and Dexamethasone Phosphate to Treat Dry Eye
Lead Sponsor:
Eyegate Pharmaceuticals, Inc.
Conditions:
Dry Eye Syndrome
Eligibility:
All Genders
12+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
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 Phosphat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT00765804
Start Date
October 1 2008
End Date
February 1 2009
Last Update
August 31 2010
Active Locations (2)
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1
Ophthalmic Research Associates
Andover, Massachusetts, United States, 01810
2
Ophthalmic Research Associates
North Andover, Massachusetts, United States, 01845