Official Title: “Topical Cyclosporine and Disease Progression”

The purpose of this study is to evaluate the effect Restasis has in regards to disease progression.

Study Type: Interventional

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

Study Primary Completion Date: September 2008

Intervention(s) in this Clinical Trial

• Drug: Restasis
  • Restasis- (in the eye) Instill one drop twice daily Endura- (in the eye) Instill one drop twice daily
• Drug: Endura
  • Restasis- (in the eye) Instill one drop twice daily Endura- (in the eye) Instill one drop twice daily

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1.
• Placebo Comparator: 2.

Primary Measures

• Disease Severity
  • Time Frame: 1 yr
    Safety Issue?: No

Secondary Measures

• Staining
  • Time Frame: 1 yr
    Safety Issue?: No

Inclusion Criteria:

• Mild to Moderate dry eye symptoms

Exclusion Criteria:

• Current use of Restasis

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?: Accepts Healthy Volunteers

Lead Sponsor: Innovative Medical

Overall Clinical Trial Officials and Contacts

Sanjay Rao Principal Investigator Lakeside Eye Clinic  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00567983

Study ID Number: 13717A

ClinicalTrials.gov Identifier: NCT00567983

Health Authority: United States: Institutional Review Board