Circadian Rhythms of Aqueous Humor Dynamics in Humans

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to identify physiological, pharmacological and pathological circadian fluctuations in aqueous humor inflow and outflow, systemic blood pressure and ocular blood flow in humans.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Nebraska
• Collaborator: Pfizer
• Treatments: Dorzolamide; Latanoprost; Timolol

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 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 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.