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

Not Applicable

Completed

• Conditions: Glaucoma; Ocular Hypertension
• Interventions: Drug: brimonidine tartrate/timolol fixed combination ophthalmic solution; Drug: brimonidine tartrate ophthalmic solution; Other: fixed combination vehicle; Drug: timolol ophthalmic solution

• Registration Number: NCT01229462
• Lead Sponsor: Allergan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-26
• Study First Submitted QC: 2010-10-26
• Study First Posted: 2010-10-27
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2012-08
• Results First Submitted: 2012-08-15
• Results First Submitted QC: 2012-08-15
• Last Update Submitted: 2012-08-15
• Results First Posted: 2012-09-14
• Last Update Posted: 2012-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 238

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combigan®	fixed combination vehicle	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.
Combigan®	brimonidine tartrate/timolol fixed combination ophthalmic solution	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.
Alphagan® and Timolol Concurrent	brimonidine tartrate ophthalmic solution	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.
Alphagan® and Timolol Concurrent	timolol ophthalmic solution	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye at Week 4	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).