12-Month Stability of Diurnal IOP Control on Cosopt - Tabular View

Tracking Information

First Received Date ^ICMJE

September 21, 2006

Last Updated Date

March 28, 2007

Start Date ^ICMJE

September 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Diurnal IOP control
Adverse events

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00379834 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

12-Month Stability of Diurnal IOP Control on Cosopt

Official Title ^ICMJE

12-Month Stability of Diurnal IOP Control on Cosopt

Brief Summary

To determine the stability of diurnal intraocular pressure in eyes with glaucoma treated with Cosopt

Detailed 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.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Glaucoma

Intervention ^ICMJE

Drug: Cosopt

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

March 2008

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

bilateral OAG

Exclusion Criteria:

contraindications to Cosopt
pathology affecting tonometry

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00379834

Responsible Party

Study ID Numbers ^ICMJE

31861

Study Sponsor ^ICMJE

West Virginia University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Anthony D Realini, MD

West Virginia University

Information Provided By

West Virginia University

Verification Date

March 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP