Back to results24-hour IOP-lowering Effect of Brimonidine 0.1%
Primary Purpose
Open-angle Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
brimonidine 0.1% (Alphagan® P)
Sponsored by
About this trial
This is an interventional treatment trial for Open-angle Glaucoma
Eligibility Criteria
Inclusion Criteria:
- patients with open-angle glaucoma or ocular hypertension
Exclusion Criteria:
- allergy to brimonidine
- inability to complete 24 hour stay for monitoring
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
brimonidine 0.1%
Arm Description
brimonidine 0.1%
Outcomes
Primary Outcome Measures
Intraocular Pressure (IOP) for a 24-Hour Period at Week 4
IOP for a 24-hour period separated into diurnal(7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at week 4. IOP is a measurement of the fluid pressure inside the eye. Measurements of IOP were taken in the sitting and supine (laying down face up) body positions during the 16-hour diurnal (awake) period and in the supine position during the 8-hour nocturnal (sleep) period.
Secondary Outcome Measures
Change From Baseline in Intraocular Pressure (IOP) for a 24-Hour Period at Week 4
Change from baseline in IOP for a 24-hour period separated into diurnal (7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at week 4. IOP is a measurement of the fluid pressure inside the eey. Measurements of IOP were taken in the sitting and supine (laying down face up) body positions during the 16-hour diurnal (awake) period and in the supine position during the 8-hour nocturnal (sleep) period. A negative number change from baseline indicates an improvement.
Ocular Perfusion Pressure (OPP) for a 24-Hour Period at Week 4
Ocular perfusion pressure (OPP) calculated for a 24-hour period separated into diurnal (7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at week 4. Ocular perfusion pressure is blood pressure minus the intraocular pressure, which is a measurement of the fluid pressure inside the eye. Measurements of IOP and blood pressure were taken in the sitting and supine (laying down face up) body positions during the 16-hour diurnal (awake) period and in the supine position during the 8-hour nocturnal (sleep) period.
Change in Ocular Perfusion Pressure (OPP) Over a 24-Hour Period at Week 4
Change in ocular perfusion pressure (OPP) calculated over a 24-hour period separated into diurnal (7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at Week 4. Ocular perfusion pressure is blood pressure minus the intraocular pressure, which is a measurement of the fluid pressure inside the eye. Measurements of IOP and blood pressure were taken in the sitting and supine (laying down face up) body positions during the 16-hour (awake) period and in the supine position during the 8-hour nocturnal (sleep) period.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00457795
Brief Title
24-hour IOP-lowering Effect of Brimonidine 0.1%
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
5. Study Description
Brief Summary
This study will evaluate the efficacy and safety of brimonidine 0.1% three-times daily in patients with glaucoma or ocular hypertension
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open-angle Glaucoma, Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
brimonidine 0.1%
Arm Type
Experimental
Arm Description
brimonidine 0.1%
Intervention Type
Drug
Intervention Name(s)
brimonidine 0.1% (Alphagan® P)
Other Intervention Name(s)
Alphagan® P
Intervention Description
Brimonidine 0.1%, 1 drop three-times daily for 4 weeks
Primary Outcome Measure Information:
Title
Intraocular Pressure (IOP) for a 24-Hour Period at Week 4
Description
IOP for a 24-hour period separated into diurnal(7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at week 4. IOP is a measurement of the fluid pressure inside the eye. Measurements of IOP were taken in the sitting and supine (laying down face up) body positions during the 16-hour diurnal (awake) period and in the supine position during the 8-hour nocturnal (sleep) period.
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
Change From Baseline in Intraocular Pressure (IOP) for a 24-Hour Period at Week 4
Description
Change from baseline in IOP for a 24-hour period separated into diurnal (7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at week 4. IOP is a measurement of the fluid pressure inside the eey. Measurements of IOP were taken in the sitting and supine (laying down face up) body positions during the 16-hour diurnal (awake) period and in the supine position during the 8-hour nocturnal (sleep) period. A negative number change from baseline indicates an improvement.
Time Frame
Baseline, Week 4
Title
Ocular Perfusion Pressure (OPP) for a 24-Hour Period at Week 4
Description
Ocular perfusion pressure (OPP) calculated for a 24-hour period separated into diurnal (7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at week 4. Ocular perfusion pressure is blood pressure minus the intraocular pressure, which is a measurement of the fluid pressure inside the eye. Measurements of IOP and blood pressure were taken in the sitting and supine (laying down face up) body positions during the 16-hour diurnal (awake) period and in the supine position during the 8-hour nocturnal (sleep) period.
Time Frame
Week 4
Title
Change in Ocular Perfusion Pressure (OPP) Over a 24-Hour Period at Week 4
Description
Change in ocular perfusion pressure (OPP) calculated over a 24-hour period separated into diurnal (7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at Week 4. Ocular perfusion pressure is blood pressure minus the intraocular pressure, which is a measurement of the fluid pressure inside the eye. Measurements of IOP and blood pressure were taken in the sitting and supine (laying down face up) body positions during the 16-hour (awake) period and in the supine position during the 8-hour nocturnal (sleep) period.
Time Frame
Week 4
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:
patients with open-angle glaucoma or ocular hypertension
Exclusion Criteria:
allergy to brimonidine
inability to complete 24 hour stay for monitoring
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Affairs
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
San Diego
State/Province
California
Country
United States
12. IPD Sharing Statement
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24-hour IOP-lowering Effect of Brimonidine 0.1%
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