Aqueous Humor Dynamics and Brimonidine (Brimonidine)
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|ClinicalTrials.gov Identifier: NCT01144494|
Recruitment Status : Completed
First Posted : June 15, 2010
Last Update Posted : March 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Intraocular Pressure||Drug: Brimonidine Drug: Artificial tears||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Circadian Rhythms of Aqueous Humor Dynamics in Subjects With Ocular Hypertension Using Brimonidine|
|Actual Study Start Date :||June 2010|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||January 2012|
Active Comparator: Intraocular pressure lowering drug
Eyedrops for lowering intraocular pressure
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
- Aqueous Humor Dynamics [ Time Frame: 1 year ]To look at aqueous humor dynamics at night when taking brimonidine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01144494
|United States, Nebraska|
|University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198-5540|
|Principal Investigator:||Carol B Toris, PhD||Research Instructor|