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24-hour IOP-lowering Effect of 0.01% Bimatoprost

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ClinicalTrials.gov Identifier: NCT01271686
Recruitment Status : Completed
First Posted : January 7, 2011
Results First Posted : June 19, 2014
Last Update Posted : June 19, 2014
Sponsor:
Information provided by (Responsible Party):
John Liu, PhD, University of California, San Diego

Study Description
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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

Condition or disease Intervention/treatment Phase
Intraocular Pressure Glaucoma Ocular Hypertension Drug: 0.01% bimatoprost Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 24-hour IOP-lowering Effect of 0.01% Bimatoprost
Study Start Date : January 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Bimatoprost

Arms and Interventions
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Arm Intervention/treatment
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%


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


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
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
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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
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United States, California
UCSD Shiley Eye Center
La Jolla, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: John Liu, PhD University of California, San Diego
More Information
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Additional Information:

Publications of Results:

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Responsible Party: John Liu, PhD, Adjunct Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01271686    
Other Study ID Numbers: UCSD 101705 bimatoprost
First Posted: January 7, 2011    Key Record Dates
Results First Posted: June 19, 2014
Last Update Posted: June 19, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Ocular Hypertension
Eye Diseases
Bimatoprost
Antihypertensive Agents