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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:
ClinicalTrials.gov Identifier:
NCT00822055
First Posted: January 14, 2009
Last Update Posted: January 14, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Allergan
January 13, 2009
January 14, 2009
January 14, 2009
May 2005
November 2006   (Final data collection date for primary outcome measure)
Change from baseline in mean IOP [ Time Frame: 12 weeks ]
Same as current
No Changes Posted
Patient tolerability/comfort measured by Likert scale [ Time Frame: Month 1 ]
Same as current
Not Provided
Not Provided
 
Comparison of the Fixed Combinations of Brimonidine/Timolol and Dorzolamide/Timolol in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Not Provided
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
  • Open-Angle Glaucoma
  • Ocular Hypertension
  • Drug: brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination
    1 drop BID in each eye
    Other Name: Combigan®
  • Drug: dorzolamide hcl 2%/timolol maleate 0.5% fixed combination
    1 drop BID in each eye
    Other Name: Cosopt®
  • 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®
  • 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®
  • Active Comparator: 1
    brimonidine/timolol Fixed-combination monotherapy
    Intervention: Drug: brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination
  • Active Comparator: 2
    dorzolamide/timolol fixed-combination monotherapy
    Intervention: Drug: dorzolamide hcl 2%/timolol maleate 0.5% fixed combination
  • Active Comparator: 3
    prostaglandin analogue + brimonidine/timolol fixed combination
    Intervention: Drug: brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy
  • Active Comparator: 4
    prostaglandin analogue + dorzolamide/timolol fixed combination
    Intervention: Drug: dorzolamide hcl 2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
November 2006
November 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00822055
COM0501
No
Not Provided
Not Provided
Therapeutic Area Head, Allergan, Inc.
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP