ABOUT THIS STUDY
- Subjects must be nineteen (19) years of age or older. Subjects must be able and willing to give written informed consent [i.e., each subject will be given ample time to read (or have read to them) the consent form, ask any questions they may have regarding the study, and have a clear understanding of the study as well as the procedures involved, prior to signing the consent form].
- Subjects must exhibit a willingness to comply with the protocol and investigator's instructions.
- Subjects must have been previously diagnosed with unilateral or bilateral ocular hypertension at least six months prior to the screening visit.
- Subjects must exhibit baseline IOPs between 21 and 35 mmHg (inclusive); the average IOP between eyes must be ≤ 5 mmHg
- Subjects will be age matched to ocular hypotensive subjects
- Subjects must exhibit baseline IOPs between 12 and 20 mmHg (inclusive); the average IOP between eyes must be ≤ 5 mmHg
- Age less than nineteen years old.
- Women who are pregnant, lactating or of childbearing potential who are not using
highly effective birth control measures.
- Aphakia or pseudophakia
- Best corrected visual acuity worse than 20/60 in either eye.
- Chronic or recurrent severe ocular inflammatory disease.
- Ocular infection or inflammation within three (3) months of screening visit.
- History of clinically significant or progressive retinal disease such as retinal
degeneration, diabetic retinopathy or retinal detachment.
- Any abnormality preventing reliable tonometry of either eye.
- Previous exposure to: beta-adrenergic antagonists, topical prostaglandin analogues
(including latanoprost, unoprostone, travoprost and bimatoprost) within six (6) weeks
of the baseline visit; α-adrenergic agonists within two (2) weeks of the baseline
visit; and cholinergic agonists and carbonic anhydrase inhibitors within five (5) days
of the treatment initiation visit
- History of any severe ocular pathology (including severe dry eye) that would preclude
the administration of a topical beta blocker, carbonic anhydrase inhibitor, or a
- Any eye with a cup-to-disc ratio greater than 0.8.
- History of intraocular surgery.
- History of ocular laser surgery.
- History of severe or serious hypersensitivity to topical or systemic beta blockers,
prostaglandins, or sulfa drugs.
- History of severe, unstable or uncontrolled cardiovascular, hepatic or renal disease.
- History of bronchial asthma or chronic obstructive pulmonary disease (COPD).
- Less than one month (prior to baseline) stable dosing regimen of any non-glaucoma
medication that would affect IOP.
- Gonioscopy angle < 2.
- Inability to be dosed with treatment medication.
- Inability to discontinue contact lens wear.
- Therapy with any investigational agent within 30 days of screening.
- Use of any additional topical or systemic adjunctive ocular hypotensive medications
during the study.
- History of open angle glaucoma (either primary open angle glaucoma or other cause of
open angle glaucoma) or narrow angle glaucoma.
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