Status:
COMPLETED
Efficacy of Optive Versus Systane 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
The purpose of this study is to evaluate the efficacy of Optive versus Systane used concomitantly with topical cyclosporine for the treatment of dry eye.
Eligibility Criteria
Inclusion
- · Males or females \> 18 years old
- Score of at least 2 and no more than 4 on the SESOD at the initial screening visit (mild to severe patients)
- At least Grade 2 conjunctival staining
- Likely to complete all study visits and able to provide informed consent
Exclusion
- · Prior unsuccessful use of topical cyclosporine (defined as patients taking it at least 3 months and saw no improvements)
- Current use of topical cyclosporine
- 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.
- Planned use of contact lenses (unless discontinued use ³ 30 days prior to randomization)
- Active ocular diseases or uncontrolled systemic disease (blepharitis patients that are actively being treated or disease that is uncontrollable)
- Ocular surgery within the past 3 months,
- Active ocular allergies
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00399061
Start Date
November 1 2006
End Date
September 1 2008
Last Update
September 25 2008
Active Locations (1)
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1
Dr. Schultze
Slingerlands, New York, United States, 12159