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

Information source: Allergan
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Glaucoma; Ocular Hypertension

Intervention: brimonidine tartrate/timolol fixed combination ophthalmic solution (Drug); brimonidine tartrate ophthalmic solution (Drug); timolol ophthalmic solution (Drug); fixed combination vehicle (Other)

Phase: N/A

Status: Completed

Sponsored by: Allergan

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan


This study will evaluate the safety and efficacy of brimonidine tartrate/timolol fixed combination (CombiganŽ) compared with brimonidine tartrate (AlphaganŽ) and timolol in patients with glaucoma or ocular hypertension who do not respond well to topical beta blockers.

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye at Week 4


Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.


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

Locations and Contacts

Guangzhou, Guangdong, China
Additional Information

Starting date: October 2010
Last updated: August 15, 2012

Page last updated: August 23, 2015

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