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

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 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.

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 combination as adjunctive to current prostaglandin therapy	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment

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 tartrate Dorzolamide Dorzolamide hydrochloride

U.S. FDA Resources

Further study details as provided by Allergan:

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:	May 2005
Study Completion Date:	November 2006
Primary Completion Date:	November 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: Cosopt®

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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00822055

Locations

Canada, Ontario

Barrie, Ontario, Canada

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

No publications provided by Allergan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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:	Therapeutic Area Head, Allergan, Inc.
ClinicalTrials.gov Identifier:	NCT00822055 History of Changes
Other Study ID Numbers:	COM0501
Study First Received:	January 13, 2009
Last Updated:	January 13, 2009
Health Authority:	Canada: Health Canada

Additional relevant MeSH terms:

Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Timolol
Brimonidine
Dorzolamide
Maleic acid
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Enzyme Inhibitors
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Carbonic Anhydrase Inhibitors

ClinicalTrials.gov processed this record on June 17, 2013