Circadian Rhythms of Aqueous Humor Dynamics in Humans
Condition: Glaucoma
MeSH terms: Glaucoma
Intervention: Latanoprost; Dorzolamide; Timolol
Intervention description: prostaglandin; carbonic anhydrase inhibitor; beta blocker
Intervention MeSH terms: Timolol; Dorzolamide; Latanoprost
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Glaucoma; Ocular Hypertension; Timolol®, Latanoprost® and Dorzolamide®

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.
    

Eligibility 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.