Comparison of the Fixed Combinations of Brimonidine/Timolol and Dorzolamide/Timolol in Subjects With Open-Angle Glaucoma or Ocular Hypertension

January 13, 2009 updated by: Allergan
This study compares the efficacy and tolerability/comfort of brimonidine/timolol and dorzolamide/timolol in patients with open-angle glaucoma or ocular hypertension. In an investigator masked randomisation process, each subject is allocated to received either brimonidine/timolol or dorzolamide/timolol as fixed-combination monotherapy or as an adjunctive to a prostaglandin analogue for a period of 12 weeks. After screening, patient returns at baseline, Month 1 and Month 3 for ophthalmic evaluations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Barrie, Ontario, Canada

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:

  • Male or female over 18 years
  • Female subjects of childbearing potential must have negative pregnancy test and practice contraception
  • Subjects must have confirmed diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes
  • Subjects who are or have been insufficiently responsive to IOP reducing monotherapy and use of either study medication is deemed appropriate
  • Subjects able to complete questionnaires and provide informed consent

Exclusion Criteria:

  • Female subjects who are pregnant, planning to become pregnant during study period, breast feeding or not practicing a reliable method of birth control
  • Subjects wherein the study drugs are contraindicated
  • Subjects who have had intraocular surgery with 6 months (3 months for laser)
  • Subjects with known side effects/allergy or sensitivity to any component of study treatments
  • Subjects with any uncontrolled systemic disease

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: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
brimonidine/timolol Fixed-combination monotherapy
Drug: brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination
1 drop BID in each eye
Other Names:
  • Combigan®
Active Comparator: 2
dorzolamide/timolol fixed-combination monotherapy
Drug: dorzolamide hcl 2%/timolol maleate 0.5% fixed combination
1 drop BID in each eye
Other Names:
  • Cosopt®
Active Comparator: 3
prostaglandin analogue + brimonidine/timolol fixed combination
Drug: brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy
1 drop BID in each eye
Other Names:
  • Combigan®
Active Comparator: 4
prostaglandin analogue + dorzolamide/timolol fixed combination
Drug: dorzolamide hcl 2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy
1 drop BID in each eye
Other Names:
  • Cosopt®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in mean IOP
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient tolerability/comfort measured by Likert scale
Time Frame: Month 1
Month 1

Collaborators and Investigators

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

Sponsor

Allergan

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

May 1, 2005

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

January 13, 2009

First Submitted That Met QC Criteria

January 13, 2009

First Posted (Estimate)

January 14, 2009

Study Record Updates

Last Update Posted (Estimate)

January 14, 2009

Last Update Submitted That Met QC Criteria

January 13, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COM0501

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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