- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00822081
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: Bp Consulting, Inc
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 randomization process, each subject is allocated to recieve either brimonidine/timolol or dorzolamide/timolol as fixed-combination monotherapy or as an adjuctive to a prostoglandin 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
- Drug: brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination
- Drug: dorzolamide hcl 2%/ timolol maleate 0.5% fixed combination
- Drug: brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy.
- Drug: dorzolamide hcl 2%/timolol maleate 0.5% fixed combinatin as adjunctive to current prostaglandin therapy.
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
-
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Ontario
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Barrie, Ontario, Canada
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-
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 yrs.
- Female subjects of childbearing potential must have negative pregnancy test and provide 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 containdicated.
- Subjects who have had introcular 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.
|
1 drop BID in each eye
Other Names:
|
Active Comparator: 2
dorzolamide/timolol. Fixed-combination monotherapy.
|
1 drop BID in each eye
Other Names:
|
Active Comparator: 3
prostaglandin analogue+ brimonidine/timolol fixed combination.
|
1 drop BID in each eye
Other Names:
|
Active Comparator: 4
prostaglandin analogue+dorzolamide/timolol fixed combination.
|
1 drop BID in each eye
Other Names:
|
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
Collaborators
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.
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
January 1, 2005
Primary Completion (Actual)
April 1, 2006
Study Completion (Actual)
April 1, 2006
Study Registration Dates
First Submitted
January 12, 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
- Cardiovascular Diseases
- Vascular Diseases
- Eye Diseases
- Glaucoma
- Glaucoma, Open-Angle
- Ocular Hypertension
- Hypertension
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Enzyme Inhibitors
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Carbonic Anhydrase Inhibitors
- Timolol
- Brimonidine Tartrate
- Dorzolamide
- Maleic acid
- Brimonidine Tartrate, Timolol Maleate Drug Combination
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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