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A Safety and Efficacy Study of Fixed-Combination Bimatoprost and Brimonidine in Chronic 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: Fixed-Combination Bimatoprost/Brimonidine (Drug); Bimatoprost Ophthalmic Solution 0.01% (Drug); Vehicle Ophthalmic Solution (Drug); Brimonidine Tartrate Ophthalmic Solution 0.2% (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Allergan

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


This is a safety and efficacy study of fixed-combination bimatoprost and brimonidine compared with LUMIGANŽ and ALPHAGANŽ in patients with chronic glaucoma or ocular hypertension.

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 Average Eye Mean Diurnal Intraocular Pressure (IOP)

Secondary outcome:

Change From Baseline in Average Eye Mean Diurnal IOP

Average Eye Mean Diurnal IOP


Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Diagnosis of ocular hypertension or glaucoma

- Requires intraocular pressure (IOP)-lowering therapy

Exclusion Criteria:

- Cataract surgery in one eye

- Ocular laser or intraocular surgery within 6 months

- Refractive surgery in either eye

- Anticipated use of contact lenses during the study

- Expected use of artificial tears during the study

Locations and Contacts

Newport Beach, California, United States
Additional Information

Starting date: June 2013
Last updated: January 16, 2015

Page last updated: August 23, 2015

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