Aqueous Humor Dynamics and Brimonidine (Brimonidine)
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|ClinicalTrials.gov Identifier: NCT01144494|
Recruitment Status : Completed
First Posted : June 15, 2010
Results First Posted : April 24, 2019
Last Update Posted : May 22, 2019
|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
- 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 [ Time Frame: 6 weeks ]Seated day-time and supine day-time IOP was measured by pneumatonometer at 9 am and 11 am. Seated night-time IOP was measured at 9 pm and 11 pm.
- Supine Night-time & Day-time Seated Episcleral Venous Pressure (EVP) [ Time Frame: 6 weeks plus 2 days ]The episcleral venous pressure was measured using the episcleral venomanometer
- Aqueous Flow [ Time Frame: 6 weeks ]Measured by fluorophotometry during the day and night on 29 participants.
- Uveoscleral Outflow [ Time Frame: 6 weeks ]Calculated from the modified Goldmann equation using data obtained at 9 am and 11 am. Goldmann equation involves data from aqueous flow, tonography/outflow facility, episcleral venous pressure and IOP. Tonography/outflow facility data on 2 participants were not reliable, therefore uveosleral outflow analysis was performed on 27 participants.
- Outflow Facility [ Time Frame: 6 weeks ]Calculated from the measurement taken during the day and night. Tonography/outflow facility data was not reliable in 2 of the participants, therefore analysis was conducted on data from 27 participants.
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|