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: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment

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

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

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

Lead Sponsor: Innovative Medical

Overall Clinical Trial Officials and Contacts

Karl Stonecipher, MD Principal Investigator Southeastern Laser and Refractive Surgery  

Information obtained from ClinicalTrials.gov on July 02, 2009

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