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:
Collaborator:
Allergan
Information provided by:
Bp Consulting, Inc
ClinicalTrials.gov Identifier:
NCT00822081
First received: January 12, 2009
Last updated: January 13, 2009
Last verified: January 2009
  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 4

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

Resource links provided by NLM:


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
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 combinatin 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 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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Therapeutic Area Hand, Allergan, Inc.
ClinicalTrials.gov Identifier: NCT00822081     History of Changes
Other Study ID Numbers: COM0501
Study First Received: January 12, 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 April 23, 2014