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

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: Ocular Hypertension; Open-Angle Glaucoma
• 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 combination as adjunctive to current prostaglandin therapy

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Barrie, Ontario, Canada

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

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	12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Allergan

Publications and helpful links

General Publications

• 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. doi: 10.1185/03007990902994041.

Study record dates

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: 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