Topical Cyclosporine and Disease Progression

Verified by: Innovative Medical, September 2008
First Received: December 3, 2007 | Last Updated: September 23, 2008 | Phase: Phase 4 | Start Date: December 2007
Overall Status: Completed | Estimated Enrollment: 80
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The purpose of this study is to evaluate the effect Restasis has in regards to disease progression...

Brief Summary

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: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
  • 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.

Outcome Measures for this Clinical Trial

Primary Measures

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

Secondary Measures

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

Criteria for Participation in this Clinical Trial

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

Clinical Trial Investigator Information

Lead Investigator: Innovative Medical Industry

Overall Clinical Trial Officials and Contacts

Sanjay Rao Principal Investigator Lakeside Eye Clinic  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

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

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00567983