24-hour IOP-lowering Effect of 0.01% Bimatoprost
|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|
|Primary Completion Date :||October 2012|
|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.
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|