Will Restasis Eye Drops Increase Your Chance of Having a Successful 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...
Brief Summary
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
- Study Primary Completion Date: June 2005
Detailed Clinical Trial Description
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
Outcome Measures for this Clinical Trial
Primary Measures
- intraocular pressure
- Time Frame: 6 months
Safety Issue?: No
- Time Frame: 6 months
Secondary Measures
- ocular inflammation
- Time Frame: 6 months
Safety Issue?: No
- Time Frame: 6 months
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: Wills Eye Other
Overall Clinical Trial Officials and Contacts
Marlene R. Moster, MD Principal Investigator Wills Eye Glaucoma Research Center
Related Publications
Citations Reporting Results
Fakhraie G, Lopes JF, Spaeth GL, Almodin J, Ichhpujani P, Moster MR. Effects of postoperative cyclosporine ophthalmic emulsion 0.05% (Restasis) following glaucoma surgery. Clin Experiment Ophthalmol. 2009 Dec;37(9):842-8.
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
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
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00405431
