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

Study Identifier
COM0501
CT.gov Identifier
NCT00822055
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Glaucoma - Open Angle
  • Ocular Hypertension
    • Study Drug
  • brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination
  • dorzolamide hcl 2%/timolol maleate 0.5% fixed combination
  • brimonidine tartrate 0.2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy
  • dorzolamide hcl 2%/timolol maleate 0.5% fixed combination as adjunctive to current prostaglandin therapy
    • Phase
    Phase 4
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion 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

    Protocol 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 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 Locations

    Location
    Status
    Location
    Barrie, Ontario, Canada
    Status
    Not applicable