NCT01271686

24-hour IOP-lowering Effect of 0.01% Bimatoprost

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the 24-hour IOP-lowering efficacy of 0.01% bimatoprost once daily in patients with glaucoma or ocular hypertension

Detailed description

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.

Conditions

• Intraocular Pressure
• Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	0.01% bimatoprost	0.01% bimatoprost once in the evening for 4 weeks

Timeline

• Start date: 2011-01-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2011-01-07
• Last updated: 2014-06-19
• Results posted: 2014-06-19

Locations

1 site across 1 country: United States