Phase 2
N=28
Circadian Rhythms of Aqueous Humor Dynamics in Humans
Glaucoma
Bottom Line
View on ClinicalTrials.gov: NCT00572936 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcome: Primary: Intraocular Pressure — 17.6; 16.4; 20.2; 17.0 mmHg — p=<.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Latanoprost (Drug); Dorzolamide (Drug); Timolol (Drug)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- University of Nebraska
- Primary completion
- Nov 2009
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 |
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.
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.