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12-Month Stability of Diurnal IOP Control on Cosopt

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. Identifier: NCT00379834
Recruitment Status : Completed
First Posted : September 25, 2006
Results First Posted : February 10, 2015
Last Update Posted : February 10, 2015
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
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
Drug Information available for: Dorzolamide

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)

Information from the National Library of Medicine

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

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 identifier (NCT number): NCT00379834

Sponsors and Collaborators
West Virginia University
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Principal Investigator: Anthony D Realini, MD West Virginia University
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Responsible Party: Anthony D. Realini, Associate Professor, West Virginia University Identifier: NCT00379834    
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:
intraocular pressure
Additional relevant MeSH terms:
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Ocular Hypertension
Eye Diseases
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors