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

Sponsors and Collaborators:	Bp Consulting, Inc Allergan
Information provided by:	Bp Consulting, Inc
ClinicalTrials.gov Identifier:	NCT00822081

Purpose

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.

Condition	Intervention	Phase
Open-Angle Glaucoma Ocular Hypertension	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.	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

Drug Information available for: Timolol Timolol maleate Brimonidine Brimonidine tartrate Dorzolamide Dorzolamide hydrochloride Cosopt

U.S. FDA Resources

Further study details as provided by Bp Consulting, Inc:

Primary Outcome Measures:

Change from baseline in mean IOP. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patient tolerability/comfort measured by Likert scale. [ Time Frame: Month 1 ] [ Designated as safety issue: No ]

Enrollment:	140
Study Start Date:	January 2005
Study Completion Date:	April 2006
Primary Completion Date:	April 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator brimonidine/timolol. Fixed-combination monotherapy.	Drug: brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination 1 drop BID in each eye
2: Active Comparator dorzolamide/timolol. Fixed-combination monotherapy.	Drug: dorzolamide hcl 2%/ timolol maleate 0.5% fixed combination 1 drop BID in each eye
3: Active Comparator 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
4: Active Comparator prostaglandin analogue+dorzolamide/timolol fixed combination.	Drug: dorzolamide hcl 2%/timolol maleate 0.5% fixed combinatin as adjunctive to current prostaglandin therapy. 1 drop BID in each eye

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00822081

Locations

Canada, Ontario

Barrie, Ontario, Canada

Sponsors and Collaborators

Bp Consulting, Inc

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

No publications provided by Bp Consulting, Inc

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Nixon DR, Yan DB, Chartrand JP, Piemontesi RL, Simonyi S, Hollander DA. Three-month, randomized, parallel-group comparison of brimonidine-timolol versus dorzolamide-timolol fixed-combination therapy. Curr Med Res Opin. 2009 Jul;25(7):1645-53.

Responsible Party:	Allergan, Inc. ( Therapeutic Area Hand )
Study ID Numbers:	COM0501
Study First Received:	January 12, 2009
Last Updated:	January 13, 2009
ClinicalTrials.gov Identifier:	NCT00822081 History of Changes
Health Authority:	Canada: Health Canada

Study placed in the following topic categories:

Neurotransmitter Agents
Adrenergic alpha-Agonists
Adrenergic Agents
Eye Diseases
Vascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Adrenergic Agonists
Carbonic Anhydrase Inhibitors
Glaucoma

Maleic acid
Glaucoma, Open-Angle
Adrenergic beta-Antagonists
Adrenergic Antagonists
Anti-Arrhythmia Agents
Timolol
Ocular Hypertension
Hypertension
Brimonidine
Dorzolamide

Additional relevant MeSH terms:

Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic Agonists
Maleic acid
Glaucoma
Glaucoma, Open-Angle
Therapeutic Uses
Adrenergic beta-Antagonists
Cardiovascular Diseases
Timolol
Anti-Arrhythmia Agents

Adrenergic alpha-Agonists
Eye Diseases
Vascular Diseases
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Carbonic Anhydrase Inhibitors
Adrenergic Antagonists
Dorzolamide
Brimonidine
Ocular Hypertension
Hypertension

ClinicalTrials.gov processed this record on September 01, 2009