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24-hour IOP-lowering Effect of 0.01% Bimatoprost

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01271686
First Posted: January 7, 2011
Last Update Posted: June 19, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
John Liu, PhD, University of California, San Diego
  Purpose
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 Glaucoma Ocular Hypertension Drug: 0.01% bimatoprost Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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.

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • primary open-angle glaucoma or ocular hypertension

Exclusion Criteria:

  • Women of childbearing potential previous glaucoma surgery presence of other eye disease
  Contacts and Locations
Information from the National Library of Medicine

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


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

Additional Information:
Publications:
Responsible Party: John Liu, PhD, Adjunct Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01271686     History of Changes
Other Study ID Numbers: UCSD 101705 bimatoprost
First Submitted: January 6, 2011
First Posted: January 7, 2011
Results First Submitted: December 17, 2013
Results First Posted: June 19, 2014
Last Update Posted: June 19, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases
Bimatoprost
Antihypertensive Agents