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12-Month Stability of Diurnal IOP Control on Cosopt

This study has been completed.
Information provided by (Responsible Party):
Anthony D. Realini, West Virginia University Identifier:
First received: September 21, 2006
Last updated: January 26, 2015
Last verified: January 2015
To determine the stability of diurnal intraocular pressure in eyes with glaucoma treated with Cosopt

Condition Intervention Phase
Drug: Cosopt
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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 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.

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

Inclusion Criteria:

  • bilateral open-angle glaucoma

Exclusion Criteria:

  • contraindications to Cosopt
  • pathology affecting tonometry
  Contacts and Locations
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Please refer to this study by its identifier: NCT00379834

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

Responsible Party: Anthony D. Realini, Associate Professor, West Virginia University Identifier: NCT00379834     History of Changes
Other Study ID Numbers: 31861
Study First Received: September 21, 2006
Results First Received: July 25, 2013
Last Updated: January 26, 2015

Keywords provided by West Virginia University:
intraocular pressure

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases processed this record on May 23, 2017