To determine the stability of diurnal intraocular pressure in eyes with glaucoma treated with...
Date First Received: September 21, 2006
Last Updated: March 28, 2007
Verified by: West Virginia University, March 2007
Clinical Trial Phase: Phase 4 | Start Date: September 2006
Overall Status: Active, not recruiting
Estimated Enrollment: 10
Brief Summary
Official Title: “12-Month Stability of Diurnal IOP Control on Cosopt”
Condition Keyword(s):
Intervention(s):
To determine the stability of diurnal intraocular pressure in eyes with glaucoma treated with Cosopt
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Detailed Clinical Trial Description
Glaucoma is a potentially-blinding but treatable eye disease. A major risk factor for glaucoma is elevated intraocular pressure (IOP). IOP is a dynamic variable (like blood pressure)—it changes over time. The more it changes, the more likely patients are to get worse. Glaucoma is treated by lowering IOP. Cosopt is a medication that lowers IOP. Little is known about how well Cosopt reduces IOP fluctuations. In this study, we plan to measure the IOP in both eyes of 10 glaucoma patients treated with Cosopt, every 2 hours from 8am to 8pm, on five separate days over a one-year period. Untreated baseline IOP will be measured on a similar long day before beginning treatment with Cosopt. This methodology will allow us to compare IOP fluctuations with and without Cosopt, and also to learn about long-term control of IOP fluctuations in eyes treated with Cosopt.
Intervention(s) in this Clinical Trial
- Drug: Cosopt
Outcome Measures for this Clinical Trial
Primary Measures
- Diurnal IOP control
- Adverse events
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- bilateral OAG
Exclusion Criteria:
- contraindications to Cosopt
- pathology affecting tonometry
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 Sponsor Information
Lead Sponsor: West Virginia University
Overall Clinical Trial Officials and Contacts
Anthony D Realini, MD Principal Investigator West Virginia University
Additional Information
Information obtained from ClinicalTrials.gov on January 08, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00379834
Study ID Number: 31861
ClinicalTrials.gov Identifier: NCT00379834
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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