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12-Month Stability of Diurnal IOP Control on Cosopt

NCT ID: NCT00379834

Last Updated: 2015-02-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-04-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Glaucoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cosopt

Cosopt twice daily in both eyes

Group Type ACTIVE_COMPARATOR

Cosopt

Intervention Type DRUG

Cosopt twice daily in both eyes

Interventions

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Cosopt

Cosopt twice daily in both eyes

Intervention Type DRUG

Other Intervention Names

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Dorzolamide/timolol fixed combination

Eligibility Criteria

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Inclusion Criteria

* bilateral open-angle glaucoma

Exclusion Criteria

* contraindications to Cosopt
* pathology affecting tonometry
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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West Virginia University

OTHER

Sponsor Role lead

Responsible Party

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Anthony D. Realini

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anthony D Realini, MD

Role: PRINCIPAL_INVESTIGATOR

West Virginia University

Other Identifiers

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31861

Identifier Type: -

Identifier Source: org_study_id

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