NCT01229462

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 238 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2010-10-27
• Last updated: 2012-09-14
• Results posted: 2012-09-14

Locations

1 site across 1 country: China