Efficacy of Optive Versus Systane Concomitant With Restasis (Cyclosporine A) for the Treatment of Dry Eye Symptoms

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Optive Versus Systane Concomitant With Restasis (Cyclosporine A) for the Treatment of Dry Eye Symptoms

Conditions
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Dry Eye

Intervention / Treatment
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* Drug: Systane, Optive, Restasis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Systane | Drug: Systane, Optive, Restasis<br>* Systane 30ml (in the eye) instill one drop twice a day in morning and evening Optive 15ml (in the eye) instill one drop twice a day in morning and evening Restasis 0.4ml (in the eye) instill one drop twice a day in morning and evening more frequently if needed<br>|
| Active Comparator: 2<br>Optive | Drug: Systane, Optive, Restasis<br>* Systane 30ml (in the eye) instill one drop twice a day in morning and evening Optive 15ml (in the eye) instill one drop twice a day in morning and evening Restasis 0.4ml (in the eye) instill one drop twice a day in morning and evening more frequently if needed<br>|
| Placebo Comparator: 3<br>Restasis | Drug: Systane, Optive, Restasis<br>* Systane 30ml (in the eye) instill one drop twice a day in morning and evening Optive 15ml (in the eye) instill one drop twice a day in morning and evening Restasis 0.4ml (in the eye) instill one drop twice a day in morning and evening more frequently if needed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy |  | 1 yr 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dry eye symptoms |  | 1yr 3 months |