Skip to main content
OpenTrials
Completed

NCT Number: NCT01229462

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guangzhou, Guangdong, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

brimonidine tartrate/timolol fixed combination ophthalmic solution

Drug

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.

Other names: Combigan®

Brimonidine Tartrate Ophthalmic Solution

Drug

One drop of brimonidine tartrate ophthalmic solution (Alphagan®) administered to the affected eye(s) twice daily (morning and evening) for four weeks.

Other names: Alphagan®

Timolol ophthalmic solution

Drug

One drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.

fixed combination vehicle

Other

Fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 27, 2010
Registry last updated
Sep 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.