Status:
COMPLETED
Efficacy and Safety of a New Multi-dose Lubricant Eye Drop Concomitant With Restasis® (Cyclosporine A) for the Treatment of Dry Eye Symptoms
Lead Sponsor:
Innovative Medical
Conditions:
Dry Eye
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
To evaluate the efficacy, safety and tolerability of a combination of Optive® Artificial Tears with Restasis®.The primary hypothesis is that the Ocular Surface Disease Index (OSDI) score and symptoms ...
Eligibility Criteria
Inclusion
- · Males or females \> 18 years old
- Patients currently taking Restasis® for at least 3 months in duration and using artificial tears as needed for dry eye.
- Likely to complete all study visits and able to provide informed consent
Exclusion
- · Patients using Restasis® for less than 3 months.
- Known contraindications to any study medication or ingredients
- Female of child bearing potential not using reliable methods of birth control, or pregnant or lactating females.
- Other active uncontrolled ocular diseases or uncontrolled systemic disease
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2008
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00405457
Start Date
November 1 2006
End Date
January 1 2008
Last Update
February 22 2010
Active Locations (1)
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1
Minnesota Eye Consultants
Minneapolis, Minnesota, United States, 55404