This is a parallel group, randomized, multicenter study evaluating the comfort of
Brinzolamide 1% / Brimonidine 0. 2% Fixed Combination, Brinzolamide 1% and Brimonidine 0. 2%
Inclusion Criteria:
- Patients with a diagnosis of either open angle glaucoma (OAG) or ocular hypertension
(OHT) who are currently controlled, in the opinion of the Investigator2) Non-contact
lens wearers
Exclusion Criteria:
- Schaffer angle Grade < 2 as measured by gonioscopy within 1 year of screening visit
(extreme narrow angle with complete or partial closure)
- Patients who are unable to discontinue use of other topical ocular medications,
including OTC medications for the duration of the study
- Any corneal conditions that may be causing significant hyperalgesia or hypoalgesia
- Acute or chronic ocular allergies (i. e., seasonal allergic conjunctivitis (SAC) and
perennial allergic conjunctivitis (PAC))
- Chronic or recurrent inflammatory ocular disease (i. e., scleritis, uveitis, herpes
keratitis)
- Ocular trauma within the past 6 months
- Ocular infection or inflammation within the past 3 months
- Intra-ocular surgery within the past 6 months
- Ocular laser surgery within the past 3 months
- Cup/disc ratio > 0. 8 (horizontal or vertical measurement)
- Severe central visual field loss as determined by visual field testing within 6
months of the Screening Visit
- Hypersensitivity to α-adrenergic agonist drugs, topical or oral carbonic anhydrase
inhibitors (CAIs), sulfonamide derivatives, or any component of the study medications
in the opinion of the Investigator
- Patients who were on another investigational agent within 30 days prior to Visit 1
- History of active, severe, unstable or uncontrolled cardiovascular (e. g. coronary
insufficiency, hypertension, Raynaud's phenomenon, orthostatic hypotension,
thromboangiitis obliterans), cerebrovascular (e. g. cerebral insufficiency), hepatic,
or renal disease that would preclude the safe administration of a topical
α-adrenergic agonist or CAI in the opinion of the investigator
- History of or current evidence of severe illness or any other conditions which would
make the patient, in the opinion of the investigator, unsuitable for the study
- Patients with recent (within 4 weeks of the Screening Visit) use of high-dose (>1 g
daily) salicylate therapy
- Concurrent use of monoamine oxidase inhibitors (MAOI)
Alcon Call Center, Phone: 1-888-451-3937, Email: medical.information@alconlabs.com
