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24-hour IOP-lowering Effect of 0.01% Bimatoprost

This study has been completed.
Information provided by (Responsible Party):
John Liu, PhD, University of California, San Diego Identifier:
First received: January 6, 2011
Last updated: May 19, 2014
Last verified: May 2014
This study will evaluate the 24-hour IOP-lowering efficacy of 0.01% bimatoprost once daily in patients with glaucoma or ocular hypertension

Condition Intervention Phase
Intraocular Pressure
Ocular Hypertension
Drug: 0.01% bimatoprost
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 24-hour IOP-lowering Effect of 0.01% Bimatoprost

Resource links provided by NLM:

Further study details as provided by John Liu, PhD, University of California, San Diego:

Primary Outcome Measures:
  • Nocturnal Intraocular Pressure (IOP) Change [ Time Frame: 4 weeks ]
    Nocturnal IOP means under bimatoprost 0.01% treatment were compared with baseline.

Enrollment: 16
Study Start Date: January 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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%

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.


Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • primary open-angle glaucoma or ocular hypertension

Exclusion Criteria:

  • Women of childbearing potential previous glaucoma surgery presence of other eye disease
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Please refer to this study by its identifier: NCT01271686

United States, California
UCSD Shiley Eye Center
La Jolla, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
Principal Investigator: John Liu, PhD University of California, San Diego
  More Information

Additional Information:
Responsible Party: John Liu, PhD, Adjunct Professor, University of California, San Diego Identifier: NCT01271686     History of Changes
Other Study ID Numbers: UCSD 101705 bimatoprost
Study First Received: January 6, 2011
Results First Received: December 17, 2013
Last Updated: May 19, 2014

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases
Antihypertensive Agents processed this record on May 25, 2017