Aqueous Humor Dynamics and Brimonidine

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by University of Nebraska.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT01144494
First received: June 11, 2010
Last updated: June 14, 2010
Last verified: June 2010
  Purpose

Investigate nocturnal effects on aqueous humor dynamics of a clinically used eye pressure -lowering drug, brimonidine, when given for six weeks.


Condition Intervention
Intraocular Pressure
Drug: Brimonidine
Drug: Artificial tears

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Circadian Rhythms of Aqueous Humor Dynamics in Subjects With Ocular Hypertension Using Brimonidine

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Aqueous Humor Dynamics [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To look at aqueous humor dynamics at night when taking brimonidine


Estimated Enrollment: 30
Study Start Date: July 2010
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intraocular pressure lowering drug
Eyedrops for lowering intraocular pressure
Drug: Brimonidine
One drop of brimonidine in each eye three times a day for six weeks.
Placebo Comparator: Artificial Tears
Lubricated eye drops
Drug: Artificial tears
Lubricating drops added three times a day for six weeks
Other Name: Systane

Detailed Description:

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. Thirty volunteers with ocular hypertension (intraocular pressure greater than 20mmHg) will be enrolled.

The subjects will undergo a baseline phase and medication phase using brimonidine. At both phases, they will attend a daytime and a nighttime study visit in which fluorophotometry will be used to calculate aqueous flow (production), trabecular outflow facility, and uveoscleral outflow. At the completion of the study, subjects will return to their previous ophthalmic clinic.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01144494

Contacts
Contact: Susan L Galata, BA 402-559-5706 slgalata@unmc.edu
Contact: Carol B Toris, PhD 402-559-7492 ctoris@unmc.edu

Locations
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-5540
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Carol B Toris, PhD Research Instructor
  More Information

No publications provided

Responsible Party: Carol Toris, PhD, UNMC Department of Ophthalmology
ClinicalTrials.gov Identifier: NCT01144494     History of Changes
Other Study ID Numbers: 220-10-FB
Study First Received: June 11, 2010
Last Updated: June 14, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
Aqueous Humor Dynamics
Aqueous Humor Dynamics and Circadian Rhythms

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases
Brimonidine
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014