24-hour IOP-lowering Effect of 0.01% Bimatoprost
Primary Purpose
Intraocular Pressure, Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
0.01% bimatoprost
Sponsored by
About this trial
This is an interventional treatment trial for Intraocular Pressure
Eligibility Criteria
Inclusion Criteria:
- primary open-angle glaucoma or ocular hypertension
Exclusion Criteria:
- Women of childbearing potential previous glaucoma surgery presence of other eye disease
Sites / Locations
- UCSD Shiley Eye Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
0.01% bimatoprost
Arm Description
bimatoprost 0.01% one time per day at bedtime for 4 weeks.
Outcomes
Primary Outcome Measures
Nocturnal Intraocular Pressure (IOP) Change
Nocturnal IOP means under bimatoprost 0.01% treatment were compared with baseline.
Secondary Outcome Measures
Full Information
NCT ID
NCT01271686
First Posted
January 6, 2011
Last Updated
May 19, 2014
Sponsor
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT01271686
Brief Title
24-hour IOP-lowering Effect of 0.01% Bimatoprost
Official Title
24-hour IOP-lowering Effect of 0.01% Bimatoprost
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraocular Pressure, Glaucoma, Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
0.01% bimatoprost
Arm Type
Experimental
Arm Description
bimatoprost 0.01% one time per day at bedtime for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
0.01% bimatoprost
Other Intervention Name(s)
Lumigan 0.01%
Intervention Description
0.01% bimatoprost once in the evening for 4 weeks
Primary Outcome Measure Information:
Title
Nocturnal Intraocular Pressure (IOP) Change
Description
Nocturnal IOP means under bimatoprost 0.01% treatment were compared with baseline.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
primary open-angle glaucoma or ocular hypertension
Exclusion Criteria:
Women of childbearing potential previous glaucoma surgery presence of other eye disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Liu, PhD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD Shiley Eye Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22918671
Citation
Tung JD, Tafreshi A, Weinreb RN, Slight JR, Medeiros FA, Liu JH. Twenty-four-hour effects of bimatoprost 0.01% monotherapy on intraocular pressure and ocular perfusion pressure. BMJ Open. 2012 Aug 23;2(4):e001106. doi: 10.1136/bmjopen-2012-001106. Print 2012.
Results Reference
result
Links:
URL
http://bmjopen.bmj.com/content/2/4/e001106.full
Description
Open access publication
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24-hour IOP-lowering Effect of 0.01% Bimatoprost
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