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

May 12, 2015 updated by: Merck Sharp & Dohme LLC

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

330

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
24 hour diurnal IOP reduction after 8 weeks of treatment
Time Frame: After 8 weeks of treatment
After 8 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
IOP reduction a) from baseline at 6 weeks; b) comparison with timolol; c) comparison day versus night
Time Frame: At 6 weeks
At 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

April 12, 2005

First Submitted That Met QC Criteria

April 12, 2005

First Posted (Estimate)

April 13, 2005

Study Record Updates

Last Update Posted (Estimate)

May 13, 2015

Last Update Submitted That Met QC Criteria

May 12, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0507A-137
  • 2005_021

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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