24-hour IOP-lowering Effect of 0.01% Bimatoprost
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|ClinicalTrials.gov Identifier: NCT01271686|
Recruitment Status : Completed
First Posted : January 7, 2011
Results First Posted : June 19, 2014
Last Update Posted : June 19, 2014
|Condition or disease||Intervention/treatment||Phase|
|Intraocular Pressure Glaucoma Ocular Hypertension||Drug: 0.01% bimatoprost||Phase 4|
Objectives To investigate the 24 h effects of bimatoprost 0.01% monotherapy on intraocular pressure (IOP) and ocular perfusion pressure (OPP).
Design Prospective, open-label experimental study.
Setting Single tertiary ophthalmic clinic.
Participants Sixteen patients with diagnosed primary open-angle glaucoma (POAG) or ocular hypertension (ages, 49-77 years).
Interventions Baseline data of 24 h IOP in untreated patients were collected in a sleep laboratory. Measurements of IOP were taken using a pneumatonometer every 2 h in the sitting and supine body positions during the 16 h diurnal/wake period and in the supine position during the 8 h nocturnal/sleep period. After baseline measurements were taken, patients were treated with bimatoprost 0.01% one time per day at bedtime for 4 weeks, and then 24 h IOP data were collected under the same laboratory conditions.
Primary outcome measure of nocturnal IOP mean under bimatoprost 0.01% treatment was compared with baseline.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||24-hour IOP-lowering Effect of 0.01% Bimatoprost|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2012|
Experimental: 0.01% bimatoprost
bimatoprost 0.01% one time per day at bedtime for 4 weeks.
Drug: 0.01% bimatoprost
0.01% bimatoprost once in the evening for 4 weeks
Other Name: Lumigan 0.01%
- Nocturnal Intraocular Pressure (IOP) Change [ Time Frame: 4 weeks ]Nocturnal IOP means under bimatoprost 0.01% treatment were compared with baseline.
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): NCT01271686
|United States, California|
|UCSD Shiley Eye Center|
|La Jolla, California, United States, 92093|
|Principal Investigator:||John Liu, PhD||University of California, San Diego|