24-hour IOP-lowering Effect of 0.01% Bimatoprost

Phase 4

Completed

• Conditions: Intraocular Pressure; Ocular Hypertension; Glaucoma
• Interventions: Drug: 0.01% bimatoprost

• Registration Number: NCT01271686
• Lead Sponsor: University of California, San Diego

Brief 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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-06
• Study First Submitted QC: 2011-01-06
• Study First Posted: 2011-01-07
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Results First Submitted: 2013-12-17
• Status Verified: 2014-05
• Results First Submitted QC: 2014-05-19
• Last Update Submitted: 2014-05-19
• Results First Posted: 2014-06-19
• Last Update Posted: 2014-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• primary open-angle glaucoma or ocular hypertension

Exclusion Criteria

• Women of childbearing potential previous glaucoma surgery presence of other eye disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
0.01% bimatoprost	0.01% bimatoprost	bimatoprost 0.01% one time per day at bedtime for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Nocturnal Intraocular Pressure (IOP) Change	4 weeks	Nocturnal IOP means under bimatoprost 0.01% treatment were compared with baseline.

Trial Locations

Locations (1)

UCSD Shiley Eye Center; 🇺🇸 La Jolla, California, United States