Comparison of the Effects of Two Glaucoma Drugs Over 24 Hours

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00108017

First received: April 12, 2005

Last updated: January 27, 2010

Last verified: January 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

April 12, 2005

Last Updated Date

January 27, 2010

Start Date ^ICMJE

July 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00108017 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Comparison of the Effects of Two Glaucoma Drugs Over 24 Hours

Official Title ^ICMJE

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

Brief Summary

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Glaucoma
Ocular Hypertension

Intervention ^ICMJE

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

Study Arm (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

330

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00108017

Other Study ID Numbers ^ICMJE

2005_021, MK0507A-137

Has Data Monitoring Committee

Not Provided

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

January 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top