Study to Evaluate Safety of Brimonidine/Timolol Fixed Combination in Glaucoma or Ocular Hypertension Patients

This study evaluates the safety of brimonidine/timolol fixed combination in glaucoma or ocular hypertension patients

Completed

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Newport Beach, California, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Diagnosis of ocular hypertension or glaucoma
Patient requires IOP-lowering therapy in both eyes

Exclusion criteria

Uncontrolled medical conditions
Contraindication to β-adrenoceptor antagonist therapy or brimonidine therapy

Treatment and study plan

Brimonidine 0.2%/Timolol 0.5% Fixed Combination Ophthalmic Solution

Drug

Brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution 1 drop instilled in each eye two times daily (morning and evening)

Other names: COMBIGAN™

Concurrent brimonidine 0.2% and 0.5% timolol

Drug

Brimonidine 0.2%, 1 drop instilled in each eye three times daily (morning, afternoon, and evening) and timolol 0.5% timolol, 1 drop instilled in each eye twice daily (morning and evening) and vehicle of brimonidine combination ophthalmic solution 1 drop instilled in each eye (morning, afternoon and/or evening)

Primary outcomes

Adverse Events

Time frame: Day 10

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start: 2005
Primary completion: 2007
Study completion: 2007
First posted: Apr 3, 2008
Registry last updated: Apr 3, 2008

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.

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

Completed