Official Title: “Efficacy and Safety of a New Multi-Dose Lubricant Eye Drop Concomitant With Restasis® (Cyclosporine A) for the Treatment of Dry Eye Symptoms”

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 will be the same or lower than baseline after treatment in these patients.

The patients will tolerate the combination of Restasis® and Optive® with a low incidence of clinical adverse events.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment

Intervention(s) in this Clinical Trial

• Drug: Restasis, Optive Tears
  • Restasis and Optive Tears use twice daily more frequently if needed

Arms, Groups and Cohorts in this Clinical Trial

• Other: A

Primary Measures

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

Secondary Measures

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

Inclusion Criteria:

• · 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 Criteria:

• · 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

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

David Hardten, MD Principal Investigator Minnesota Eye Consultants  

Overall Contact: melissa Earl 951-786-0403 m.earl@imedsonline.com

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00405457

Study ID Number: 5261

ClinicalTrials.gov Identifier: NCT00405457

Health Authority: United States: Institutional Review Board