Phase 2
Completed N=28
Circadian Rhythms of Aqueous Humor Dynamics in Humans
Source: ClinicalTrials.gov NCT00572936 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcomePrimary: Intraocular Pressure — 17.6; 16.4; 20.2; 17.0 mmHg — p=<.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intraocular Pressure |
17.6; 16.4; 20.2; 17.0; 17.1; 17.6 | <.05 sig |
| PRIMARY Aqueous Flow |
2.09; 1.57; 1.75; 1.1; 1.1; 1.1 | <0.05 sig |
| PRIMARY Central Corneal Thickness |
564; 568; 564; 585; 586; 582 | 0.93 |
| PRIMARY Anterior Chamber Volume |
191; 191; 198 | 0.84 |
| PRIMARY Blood Pressure |
136; 138; 139; 143; 136; 138 | <0.05 sig |
| PRIMARY Episcleral Venous Pressure |
9.4; 9.6; 9.4 | 0.89 |
| PRIMARY Outflow Facility |
0.23; 0.23; 0.21; 0.22; 0.18; 0.20 | <0.05 sig |
| PRIMARY Uvescleral Outflow |
0.43; -0.16; 0.14; 0.90; 0.70; 0.58 | <0.05 sig |
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.
Data sourced from ClinicalTrials.gov (NCT00572936). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.