Efficacy of Optive Versus Systane Concomitant With Restasis (Cyclosporine A) for the Treatment of Dry Eye Symptoms
Phase 4
Completed
- Conditions
- Dry Eye
- Interventions
- Drug: Systane, Optive, Restasis
- Registration Number
- NCT00399061
- Lead Sponsor
- Innovative Medical
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 55
Inclusion Criteria
-
· 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 Criteria
-
· 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Systane, Optive, Restasis Systane 2 Systane, Optive, Restasis Optive 3 Systane, Optive, Restasis Restasis
- Primary Outcome Measures
Name Time Method Efficacy 1 yr 3 months
- Secondary Outcome Measures
Name Time Method Dry eye symptoms 1yr 3 months
Trial Locations
- Locations (1)
Dr. Schultze
🇺🇸Slingerlands, New York, United States