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

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment

Study Primary Completion Date: September 2008

Intervention(s) in this Clinical Trial

• Drug: Systane, Optive, Restasis
  • 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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Systane
• Active Comparator: 2
  • Optive
• Placebo Comparator: 3
  • Restasis

Primary Measures

• Efficacy
  • Time Frame: 1 yr 3 months
    Safety Issue?: No

Secondary Measures

• Dry eye symptoms
  • Time Frame: 1yr 3 months
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Innovative Medical

Overall Clinical Trial Officials and Contacts

Robert Schultze, MD Principal Investigator Slingerlands Medical Building  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00399061

Study ID Number: 5278

ClinicalTrials.gov Identifier: NCT00399061

Health Authority: United States: Institutional Review Board