Safety and Efficacy Study of Cyclosporine Ophthalmic Emulsion in Post-LASIK Patients

Verified by: Allergan, November 2011
First Received: January 28, 2008 | Last Updated: November 17, 2011 | Phase: Phase 2 | Start Date: December 2007
Overall Status: Completed | Estimated Enrollment: 137
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This study will evaluate the safety and efficacy of cyclosporine ophthalmic emulsion administered twice daily following LASIK...

Brief Summary

Official Title: “Safety and Efficacy Study of Cyclosporine Ophthalmic Emulsion in Post-LASIK Patients”

This study will evaluate the safety and efficacy of cyclosporine ophthalmic emulsion administered twice daily following LASIK surgery

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: December 2008

Intervention(s) in this Clinical Trial

  • Drug: Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
    • Cyclosporine Ophthalmic Emulsion 0.05% administered twice daily in each eye for 6 months following LASIK surgery
  • Drug: Artificial Tears REFRESH ENDURA®
    • REFRESH ENDURA® administered twice daily in each eye for 6 months following LASIK surgery

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: RESTASIS®
    • Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
  • Active Comparator: REFRESH ENDURA®
    • Artificial Tears (REFRESH ENDURA®)

Outcome Measures for this Clinical Trial

Primary Measures

  • Percentage of Patients With Clinical Success at Month 6
    • Time Frame: Month 6
      Safety Issue?: No

Secondary Measures

  • Change From Baseline in Keratocyte Density in the Anterior Flap of the Eyes at Month 6
    • Time Frame: Baseline, Month 6
      Safety Issue?: No
  • Change From Baseline in Goblet Cell Density of the Eyes at Month 6
    • Time Frame: Baseline, Month 6
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Patient is scheduled for bilateral LASIK surgery
  • Patient is in good general health
  • Eye glasses prescription of -1 to -8

Exclusion Criteria:

  • Significant Dry Eye
  • Presence of eye disease
  • Uncontrolled systemic disease

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Allergan Industry

Overall Clinical Trial Officials and Contacts

Medical Director Study Director Allergan  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00611403

Study ID Number: 192371-014

ClinicalTrials.gov Identifier: NCT00611403

Health Authority: United States: Food and Drug Administration

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