Efficacy of Cyclosporine for the Prevention and Treatment of Dry Eye Symptoms Following LASIK or Photorefractive Keratectomy

Verified by: Innovative Medical, September 2008
First Received: July 5, 2006 | Last Updated: September 23, 2008 | Phase: Phase 4 | Start Date: September 2006
Overall Status: Completed | Estimated Enrollment: 93
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The purpose of this study is to evaluate the effect of topical cyclosporine ophthalmic solution 0.05% (Restasis, Allergan) on the signs and symptoms of dry eye in patients undergoing LASIK or photorefractive keratectomy (PRK)...

Brief Summary

Official Title: “Efficacy of Topical Cyclosporine Ophthalmic Emulsion for the Prevention and Treatment of Dry Eye Symptoms Following LASIK or Photorefractive Keratectomy”

The purpose of this study is to evaluate the effect of topical cyclosporine ophthalmic solution 0.05% (Restasis, Allergan) on the signs and symptoms of dry eye in patients undergoing LASIK or photorefractive keratectomy (PRK).

  • 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: Cyclosporine, Refresh Plus
    • Cyclosporine 0.4ml (in the eye) on for 3 months instill one drop in randomized eye twice daily. Refresh Plus 0.4ml (in the eye) on for 3 months instill one drop in randomized eye twice daily.

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: 1
  • Placebo Comparator: 2

Outcome Measures for this Clinical Trial

Primary Measures

  • Dry Eye Symptoms
    • Time Frame: 1.5 years
      Safety Issue?: No

Secondary Measures

  • Dry eye signs
    • Time Frame: 1.5 yrs
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Males or females > 18 years old
  • Mild-moderate symptoms of dry eye prior to surgery
  • Scheduled to undergo bilateral LASIK or PRK
  • Likely to complete all study visits and able to provide informed consent

Exclusion Criteria:

  • Prior use of topical cyclosporine within the last 1 year
  • Known contraindications to any study medication or ingredients
  • Female of child bearing potential not using reliable methods of birth control, or pregnant or lactating females.
  • Ocular disorders
  • Active ocular diseases or uncontrolled systemic disease
  • Active ocular allergies

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?: No

Clinical Trial Investigator Information

Lead Investigator: Innovative Medical Industry

Overall Clinical Trial Officials and Contacts

Karl Stonecipher, MD Principal Investigator Southeastern Laser and Refractive Surgery  

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00349440

Study ID Number: 1121

ClinicalTrials.gov Identifier: NCT00349440

Health Authority: United States: Institutional Review Board

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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00349440