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| Sponsor: | Wills Eye |
|---|---|
| Collaborator: |
Allergan |
| Information provided by: | Wills Eye |
| ClinicalTrials.gov Identifier: | NCT00405431 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Glaucoma |
Drug: Restasis Drug: Endura (artificial tears) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Influence of Post-Operative Cyclosporine 0.05% (Restasis) on the Success of Glaucoma Filtering Surgery |
| Enrollment: | 43 |
| Study Start Date: | March 2004 |
| Study Completion Date: | November 2007 |
| Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Patients received restasis eyedrops during 6 month post-operative period
|
Drug: Restasis
1 drop in study eye twice a day X 6 months
Other Name: Restasis
|
|
Placebo Comparator: 2
Patients receive artificial tears (Endura) during 6 month post-operative period
|
Drug: Endura (artificial tears)
1 drop in study eye twice a day X 6 months
Other Name: Endura
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Pennsylvania | |
| Wills Eye Glaucoma Service | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Principal Investigator: | Marlene R. Moster, MD | Wills Eye Glaucoma Research Center |
More Information
| Responsible Party: | Marlene R. Moster, MD, Wills Eye Glaucoma Service |
| ClinicalTrials.gov Identifier: | NCT00405431 History of Changes |
| Other Study ID Numbers: | IRB #03-598 |
| Study First Received: | November 28, 2006 |
| Last Updated: | January 25, 2010 |
| Health Authority: | United States: Institutional Review Board |
|
glaucoma filtering surgery restasis conjunctival inflammation |
|
Glaucoma Ocular Hypertension Eye Diseases Cyclosporins Cyclosporine Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antifungal Agents Anti-Infective Agents Therapeutic Uses Dermatologic Agents Antirheumatic Agents |
