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12-Month Stability of Diurnal IOP Control on Cosopt

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ClinicalTrials.gov Identifier: NCT00379834
Recruitment Status : Completed
First Posted : September 25, 2006
Results First Posted : February 10, 2015
Last Update Posted : February 10, 2015
Sponsor:
Information provided by (Responsible Party):
Anthony D. Realini, West Virginia University

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

Condition or disease Intervention/treatment Phase
Glaucoma Drug: Cosopt Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 12-Month Stability of Diurnal IOP Control on Cosopt
Study Start Date : September 2006
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Cosopt
Cosopt twice daily in both eyes
Drug: Cosopt
Cosopt twice daily in both eyes
Other Name: Dorzolamide/timolol fixed combination



Primary Outcome Measures :
  1. 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)



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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

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

Responsible Party: Anthony D. Realini, Associate Professor, West Virginia University
ClinicalTrials.gov Identifier: NCT00379834     History of Changes
Other Study ID Numbers: 31861
First Posted: September 25, 2006    Key Record Dates
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