Safety and Efficacy of Brimonidine Tartrate/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension

Overview

This study will evaluate the safety and efficacy of brimonidine tartrate/timolol fixed combination (Combigan®) compared with brimonidine tartrate (Alphagan®) and timolol in patients with glaucoma or ocular hypertension who do not respond well to topical beta blockers.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: September 2011

Interventions

  • Drug: brimonidine tartrate/timolol fixed combination ophthalmic solution
    • One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) administered to the affected eye(s) twice daily (morning and evening) for four weeks.
  • Drug: brimonidine tartrate ophthalmic solution
    • One drop of brimonidine tartrate ophthalmic solution (Alphagan®) administered to the affected eye(s) twice daily (morning and evening) for four weeks.
  • Drug: timolol ophthalmic solution
    • One drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.
  • Other: fixed combination vehicle
    • Fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.

Arms, Groups and Cohorts

  • Other: Combigan®
    • One drop of brimonidine tartrate/timolol combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.
  • Active Comparator: Alphagan® and Timolol Concurrent
    • One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.

Clinical Trial Outcome Measures

Primary Measures

  • Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye at Week 4
    • Time Frame: Baseline, Week 4
    • Intraocular pressure (IOP) was measured in the study eye at baseline and Week 4. IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement).

Participating in This Clinical Trial

Inclusion Criteria

  • Open-angle glaucoma or ocular hypertension in at least one eye that is not responsive to topical beta blockers – No anticipated wearing of contact lenses during study Exclusion Criteria:

  • Active ocular disease other than glaucoma or ocular hypertension (eg, uveitis, ocular infections or severe dry eye) – Any intraocular surgery or laser (eg, cataract surgery or Lasik) within 3 months – Required regular use of other ocular medications except for occasional use of artificial tears

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Allergan
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Director, Study Director, Allergan

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