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COSOPT (Timolol/Dorzolamide Combination) Normal Tension Glaucoma Study (MK0507A-161)(COMPLETED)

NCT ID: NCT00832377

Last Updated: 2017-09-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-24

Study Completion Date

2010-03-26

Brief Summary

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A study to evaluate the effect of the 12-week treatment with timolol/dorzolamide combination eyedrops (COSOPT) on decrease in intraocular pressure (IOP) at 2 hours after the study drug administration

Detailed Description

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Conditions

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Glaucoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Timolol/Dorzolamide

Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks

Group Type EXPERIMENTAL

timolol/dorzolamide combination

Intervention Type DRUG

Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks

Interventions

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timolol/dorzolamide combination

Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks

Intervention Type DRUG

Other Intervention Names

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Cosopt

Eligibility Criteria

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Inclusion Criteria

* Patients who have not been treated with a glaucoma medication within 6 weeks prior to study participation after diagnosis with primary open-angle glaucoma
* Patients with primary open-angle glaucoma based on gonioscopy
* Patients with normal tension glaucoma diagnosed based on accompanying optic disc cupping and reappearance of visual field defect corresponding to retinal nerve fiber layer defect.
* Subjects with \< 22 mm Hg of diurnal IOP measured using Goldmann applanation tonometer (every two hours between 9 a.m. and 5 p.m.)

Exclusion Criteria

* Patients with another type of glaucoma but primary open-angle glaucoma
* Patients treated with other glaucoma medications within 6 weeks prior to study participation
* Patients with a history of chronic ocular inflammation or recurrent ocular inflammation
* Patients using contact lenses
* Patients who are allergic to timolol or dorzolamide
* Patients with a history of any of the following COSOPT (timolol/dorzolamide combination) contraindications:

* Reactive airway diseases
* Sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, cardiogenic shock
* Severe renal impairment
* Patients with a history of significant ocular trauma or intraocular surgery within 6 months before participating the study, or intraocular laser surgery within 3 months before the participating the study
* Patients with a history of a corneal disease
* Patients who are using steroid or used the drug for more than 2 weeks within 12 months before participating the study
* Pregnant women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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Kim TW, Kim M, Lee EJ, Jeoung JW, Park KH. Intraocular pressure-lowering efficacy of dorzolamide/timolol fixed combination in normal-tension glaucoma. J Glaucoma. 2014 Jun-Jul;23(5):329-32. doi: 10.1097/IJG.0b013e3182741f4d.

Reference Type RESULT
PMID: 23377586 (View on PubMed)

Other Identifiers

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2009_524

Identifier Type: -

Identifier Source: secondary_id

0507A-161

Identifier Type: -

Identifier Source: org_study_id