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...

Date First Received: January 28, 2008

Last Updated: May 5, 2008

Verified by: Allergan, May 2008

Clinical Trial Phase: Phase 2 | Start Date: December 2007

Overall Status: Recruiting

Estimated Enrollment: 80

Brief Summary

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

Condition Keyword(s):

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2009

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: 1
  • Placebo Comparator: 2

Outcome Measures for this Clinical Trial

Primary Measures

  • corneal sensitivity
    • Time Frame: Month 3
      Safety Issue?: No

Secondary Measures

  • contrast sensitivity
    • Time Frame: Months 1-6
      Safety Issue?: No
  • Schirmer tear test
    • Time Frame: Months 1-6
      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 Sponsor Information

Lead Sponsor: Allergan

Overall Clinical Trial Officials and Contacts

Medical Director Study Director Allergan  

Overall Contact: Allergan Inc  clinicaltrials@allergan.com

Additional Information

Information obtained from ClinicalTrials.gov on October 10, 2008

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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