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

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ClinicalTrials.gov Identifier: NCT00822081
Recruitment Status : Completed
First Posted : January 14, 2009
Last Update Posted : January 14, 2009
Sponsor:
Collaborator:
Allergan
Information provided by:
Bp Consulting, Inc

Brief Summary:
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 or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Study Start Date : January 2005
Actual Primary Completion Date : April 2006
Actual Study Completion Date : April 2006


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 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




Primary Outcome Measures :
  1. Change from baseline in mean IOP. [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Patient tolerability/comfort measured by Likert scale. [ Time Frame: Month 1 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00822081


Locations
Canada, Ontario
Barrie, Ontario, Canada
Sponsors and Collaborators
Bp Consulting, Inc
Allergan
Investigators
Study Director: Medical Director Allergan

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
First Posted: January 14, 2009    Key Record Dates
Last Update Posted: January 14, 2009
Last Verified: January 2009

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Timolol
Brimonidine Tartrate, Timolol Maleate Drug Combination
Dorzolamide
Brimonidine Tartrate
Maleic acid
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Enzyme Inhibitors
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Carbonic Anhydrase Inhibitors