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12-Month Stability of Diurnal IOP Control on Cosopt

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00379834
First Posted: September 25, 2006
Last Update Posted: February 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Anthony D. Realini, West Virginia University
  Purpose
To determine the stability of diurnal intraocular pressure in eyes with glaucoma treated with Cosopt

Condition Intervention Phase
Glaucoma Drug: Cosopt Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 12-Month Stability of Diurnal IOP Control on Cosopt

Resource links provided by NLM:


Further study details as provided by Anthony D. Realini, West Virginia University:

Primary Outcome Measures:
  • Diurnal Intraocular Pressure Control [ Time Frame: 12 months ]
    Change from baseline in mean diurnal IOP (measured every two hours from 8AM to 8PM) averaged across on-treatment study visits (week 1, months 1, 6, 12)


Enrollment: 10
Study Start Date: September 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cosopt
Cosopt twice daily in both eyes
Drug: Cosopt
Cosopt twice daily in both eyes
Other Name: Dorzolamide/timolol fixed combination

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • bilateral open-angle glaucoma

Exclusion Criteria:

  • contraindications to Cosopt
  • pathology affecting tonometry
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00379834


Sponsors and Collaborators
West Virginia University
Investigators
Principal Investigator: Anthony D Realini, MD West Virginia University
  More Information

Responsible Party: Anthony D. Realini, Associate Professor, West Virginia University
ClinicalTrials.gov Identifier: NCT00379834     History of Changes
Other Study ID Numbers: 31861
First Submitted: September 21, 2006
First Posted: September 25, 2006
Results First Submitted: July 25, 2013
Results First Posted: February 10, 2015
Last Update Posted: February 10, 2015
Last Verified: January 2015

Keywords provided by Anthony D. Realini, West Virginia University:
glaucoma
diurnal
intraocular pressure

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases