Official Title: “Influence of Post-Operative Cyclosporine 0.05% (Restasis) on the Success of Glaucoma Filtering Surgery”

The purpose of this study is to determine whether reducing inflammation of the surface of the eye with topical Restasis after glaucoma surgery will improve surgical outcomes and increase patient comfort.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: June 2005

Continued use of glaucoma drops can alter the outer surface of the eye and result in swelling and irritation, changing the structure of the eye. This structural change has been found to be a significant risk factor for the failure of glaucoma surgery. A comparison of how well patients do after glaucoma surgery depending on whether they use Restasis (the only prescription medication approved by the FDA for treating dry eye) or artificial tears (which can be purchased without a prescription) for 6 months following their surgery.

Intervention(s) in this Clinical Trial

• Drug: Restasis
  • 1 drop in study eye twice a day X 6 months
• Drug: Endura (artificial tears)
  • 1 drop in study eye twice a day X 6 months

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Patients received restasis eyedrops during 6 month post-operative period
• Placebo Comparator: 2
  • Patients receive artificial tears (Endura) during 6 month post-operative period

Primary Measures

• intraocular pressure
  • Time Frame: 6 months
    Safety Issue?: No

Secondary Measures

• ocular inflammation
  • Time Frame: 6 months
    Safety Issue?: No

Inclusion Criteria:

• Patients with uncontrolled glaucoma scheduled for filtering surgery

Exclusion Criteria:

• Under 18 years of age
• Unable to understand informed consent

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: Wills Eye

Overall Clinical Trial Officials and Contacts

Marlene R. Moster, MD Principal Investigator Wills Eye Glaucoma Research Center  

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00405431

Study ID Number: IRB #03-598

ClinicalTrials.gov Identifier: NCT00405431

Health Authority: United States: Institutional Review Board