Aqueous Humor Dynamics and Brimonidine
Recruitment status was Not yet recruiting
Investigate nocturnal effects on aqueous humor dynamics of a clinically used eye pressure -lowering drug, brimonidine, when given for six weeks.
|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|
- Aqueous Humor Dynamics [ Time Frame: 1 year ] [ Designated as safety issue: No ]To look at aqueous humor dynamics at night when taking brimonidine
|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)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01144494
|Contact: Susan L Galata, BAemail@example.com|
|Contact: Carol B Toris, PhDfirstname.lastname@example.org|
|United States, Nebraska|
|University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198-5540|
|Principal Investigator:||Carol B Toris, PhD||Research Instructor|