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: 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

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

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

Lead Sponsor: Allergan

Overall Clinical Trial Officials and Contacts

Medical Director Study Director Allergan  

Information obtained from ClinicalTrials.gov on July 02, 2009

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