Early Phase 1
N=33
Aqueous Humor Dynamics and Brimonidine
Intraocular Pressure
Bottom Line
View on ClinicalTrials.gov: NCT01144494 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Seated Day-time IOP 9 am and 11 am, Supine Day-time IOP 9 am and 11 am, and Seated Night-time IOP 9 pm and 11 pm — 18.1; 20.3; 18.0; 19.9 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Brimonidine (Drug); Artificial tears (Drug)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- University of Nebraska
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Seated Day-time IOP 9 am and 11 am, Supine Day-time IOP 9 am and 11 am, and Seated Night-time IOP 9 pm and 11 pm |
18.1; 20.3; 18.0; 19.9; 23.1; 25.4 | — |
| PRIMARY Supine Night-time & Day-time Seated Episcleral Venous Pressure (EVP) |
10.3; 10.3; 11.3; 11.2 | — |
| SECONDARY Aqueous Flow |
2.4; 2.3; 1.5; 1.5 | — |
| SECONDARY Uveoscleral Outflow |
0.84; 0.72 | — |
| SECONDARY Outflow Facility |
0.28; 0.28; 0.29; 0.29 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01144494). 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.