Circadian Rhythms of Aqueous Humor Dynamics in Subjects With Ocular Hypertension Using Brimonidine

0220-10-FB

This single-center, investigator-masked, crossover study is designed to investigate the circadian rhythms of aqueous humor dynamics in human subjects with ocular hypertension (OHT) before and after intervention with a commonly used ocular hypotensive medication, brimonidine for six weeks.

2010-08-01

2011-10-01

2011-10-01

Completed

Early phase I

35

Inclusion Criteria: * Subjects must be 19 years of age or older * Subjects must exhibit a history of untreated IOPs between 21 and 35 mmHg (inclusive) Exclusion Criteria: * Age less than nineteen years old * Women who are pregnant, lactating or of childbearing potential who are not using 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 (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 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 prelude the administration of a topical beta blocker, carbonic anhydrase inhibitor, or a topical prostaglandin. * 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 brimonidine or its vehicle. * 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 35, 'type': 'ACTUAL'}}

2023-11-28