Comparison of the Effects of Two Glaucoma Drugs Over 24 Hours (0507A-137)(COMPLETED)

NCT ID: NCT00108017

Last Updated: 2015-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2006-07-31

Brief Summary

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This study is comparing 2 medications for glaucoma and how effective they are at controlling glaucoma over the course of an entire day.

Detailed Description

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Conditions

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Glaucoma Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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MK0507A, dorzolamide hydrochloride (+) timolol maleate

Intervention Type DRUG

Comparator: timolol maleate

Intervention Type DRUG

Duration of Treatment: Part 1) 6 wk timolol maleate run in

Intervention Type DRUG

Part 2) 6 wk washout pd Part 3) two 8 wk active tx pds

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with glaucoma or ocular hypertension

Exclusion Criteria

* Other eye conditions
* Poor vision
* Recent eye surgery
* Use of contact lenses
* Nursing or pregnant women
* Use of some other selected medications
* Drug or alcohol abuse
* Asthma
* Slow heart beat
* Allergy or previous reaction to study drugs
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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Feldman RM, Stewart RH, Stewart WC, Jia G, Smugar SS, Galet VA. 24-hour control of intraocular pressure with 2% dorzolamide/0.5% timolol fixed-combination ophthalmic solution in open-angle glaucoma. Curr Med Res Opin. 2008 Aug;24(8):2403-12. doi: 10.1185/03007990802243366. Epub 2008 Jul 14.

Reference Type BACKGROUND
PMID: 18627642 (View on PubMed)

Olander KW, Galet VA, Jia G, Smugar SS, Stewart WC. Relationship between visual field severity and response to fixed combination dorzolamide/timolol or timolol alone. J Ocul Pharmacol Ther. 2009 Aug;25(4):357-64. doi: 10.1089/jop.2008.0104.

Reference Type BACKGROUND
PMID: 19441888 (View on PubMed)

Other Identifiers

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2005_021

Identifier Type: -

Identifier Source: secondary_id

0507A-137

Identifier Type: -

Identifier Source: org_study_id

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