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

Study Overview
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Brief Summary
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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.

Conditions
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Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: brimonidine tartrate/timolol fixed combination ophthalmic solution
* Drug: brimonidine tartrate ophthalmic solution
* Drug: timolol ophthalmic solution
* Other: fixed combination vehicle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Combigan®<br>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. | Drug: brimonidine tartrate/timolol fixed combination ophthalmic solution<br>* 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.<br>* Other names: Combigan®;Other: fixed combination vehicle<br>* Fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.<br>|
| Active Comparator: Alphagan® and Timolol Concurrent<br>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. | Drug: brimonidine tartrate ophthalmic solution<br>* One drop of brimonidine tartrate ophthalmic solution (Alphagan®) administered to the affected eye(s) twice daily (morning and evening) for four weeks.<br>* Other names: Alphagan®;Drug: timolol ophthalmic solution<br>* One drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye at 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). | Baseline, Week 4 |