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

This study has been completed.
Sponsor:
Information provided by:
Allergan
ClinicalTrials.gov Identifier:
NCT00822055
First received: January 13, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):
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 August 26, 2014