Table 1.

Inclusion and Exclusion Criteria for the Study

Administrative and demographic requirements: patients

• were required to be willing and able to provide informed consent before screening;

• were required to be at least 18 years of age;

• could be of either gender and any race/ethnicity; and

• could not be of childbearing potential (unless they were abstinent or using a highly effective birth control measure), pregnant or intending to become pregnant during the study, or lactating.

Ocular requirements: patients were required to have

• a clinical diagnosis of open-angle glaucoma or ocular hypertension in at least 1 (study) eye;

• a mean baseline IOP in the study eye that was, at both eligibility visits,

○ between 24 and 36 mm Hg at the 8:00 AM time point,

○ between 21 and 36 mm Hg at the 10:00 AM time point; and

• an IOP ≤36 mm Hg in both eyes at all time points of both eligibility visits.

Exclusion criteria, related to the eye: patients could not have

• any history of

○ ocular trauma or intraocular surgery within the past 6 months; or

○ ocular infection, inflammation, or laser surgery within the past 3 months; or

• any present observation of

○ any form of glaucoma other than open-angle glaucoma;

○ chronic, recurrent, or severe inflammatory eye disease;

○ central cornea thickness >620 μm, as measured by pachymetry, in either eye;

○ Shaffer angle grade <2 in either eye (range, 0 [complete or partial closure] to 3 [wide open angle, >20°]), as measured by gonioscopy;

○ cup/disc ratio >0.80 (horizontal or vertical measurement) in either eye;

○ severe central visual field loss in either eye;

○ clinically significant or progressive retinal disease;

○ best-corrected visual acuity worse than 0.6 logMAR;

○ other ocular pathology (including severe dry eye) that may preclude the administration of an alpha-adrenergic agonist and/or a topical CAI;

○ any abnormality preventing reliable applanation tonometry; or

○ an inability to safely discontinue use of or go without all IOP-lowering ocular medication(s) for the specified washout period.

Exclusion criteria, related to systemic health: patients could not

• have a recent history of using study-prohibited medications, including

○ another investigational agent within 30 days before the screening visit;

○ high-dose (>1 g daily) salicylate therapy within 4 weeks of the first eligibility visit; or

○ any medications or substances used on a chronic basis that may affect IOP and which had not been on a stable dosing regimen for at least 30 days before the screening visit;

• use any prohibited medications during the study, including

○ current or anticipated treatment with any psychotropic drugs that augment an adrenergic response;

○ concurrent use of a monoamine oxidase inhibitor; or

○ use of any additional topical or systemic ocular hypotensive medication during the study;

• have any other conditions that would make the patient unsuitable for the study, including

○ history of active, severe, unstable, or uncontrolled systemic disease precluding safe administration of a topical alpha-adrenergic agonist or CAI; or

○ hypersensitivity to alpha-adrenergic agonist drugs, topical or oral CAIs, sulfonamide derivatives, or any component of the study medications; or

• any condition that could require treatment with glucocorticoids, unless they could be safely discontinued during the study.

IOP, intraocular pressure; CAI, carbonic anhydrase inhibitor.