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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck Sharp & Dohme Corp.

ClinicalTrials.gov Identifier:

NCT00108017

First received: April 12, 2005

Last updated: May 12, 2015

Last verified: May 2015

History of Changes

Purpose

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

Condition	Intervention	Phase
Glaucoma Ocular Hypertension	Drug: MK0507A, dorzolamide hydrochloride (+) timolol maleate Drug: Comparator: timolol maleate Drug: Duration of Treatment: Part 1) 6 wk timolol maleate run in Drug: Part 2) 6 wk washout pd Part 3) two 8 wk active tx pds	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Randomized, Multicenter, Dbl-Masked, Parallel Study Evaluating the 24 Hr. Diurnal Ocular Hypotensive Effect of 2% Dorzolamide Hydrochloride/0.5% Timolol Maleate Combo. Ophthalmic Sol. in Patients w/ Open Angle Glaucoma or Ocular Hypertension

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

Drug Information available for: Timolol Timolol maleate Dorzolamide Dorzolamide hydrochloride

Genetic and Rare Diseases Information Center resources: Pigment-dispersion Syndrome

U.S. FDA Resources

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:

24 hour diurnal IOP reduction after 8 weeks of treatment [ Time Frame: After 8 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

IOP reduction a) from baseline at 6 weeks; b) comparison with timolol; c) comparison day versus night [ Time Frame: At 6 weeks ] [ Designated as safety issue: No ]


Enrollment:	330
Study Start Date:	April 2005
Study Completion Date:	July 2006
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00108017

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators


Study Director:	Medical Monitor	Merck Sharp & Dohme Corp.

More Information

Publications:

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.

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.


Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT00108017 History of Changes
Other Study ID Numbers:	0507A-137 2005_021
Study First Received:	April 12, 2005
Last Updated:	May 12, 2015
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:


Ocular hypertension (excessive pressure in the eye)

Additional relevant MeSH terms:


Hypertension Glaucoma Ocular Hypertension Vascular Diseases Cardiovascular Diseases Eye Diseases Timolol Dorzolamide Maleic acid Adrenergic beta-Antagonists	Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Arrhythmia Agents Antihypertensive Agents Enzyme Inhibitors Carbonic Anhydrase Inhibitors

ClinicalTrials.gov processed this record on September 28, 2016

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