24-hour IOP-lowering Effect of Brimonidine 0.1%
1 other identifier
interventional
15
1 country
1
Brief Summary
This study will evaluate the efficacy and safety of brimonidine 0.1% three-times daily in patients with glaucoma or ocular hypertension
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Dec 2006
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 6, 2007
CompletedFirst Posted
Study publicly available on registry
April 9, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedResults Posted
Study results publicly available
November 24, 2011
CompletedNovember 24, 2011
October 1, 2011
2.2 years
April 6, 2007
October 18, 2011
October 18, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Week 4
Secondary Outcomes (3)
Change From Baseline in Intraocular Pressure (IOP) for a 24-Hour Period at Week 4
Baseline, Week 4
Ocular Perfusion Pressure (OPP) for a 24-Hour Period at Week 4
Week 4
Change in Ocular Perfusion Pressure (OPP) Over a 24-Hour Period at Week 4
Week 4
Study Arms (1)
brimonidine 0.1%
EXPERIMENTALbrimonidine 0.1%
Interventions
Brimonidine 0.1%, 1 drop three-times daily for 4 weeks
Eligibility Criteria
You may qualify if:
- patients with open-angle glaucoma or ocular hypertension
You may not qualify if:
- allergy to brimonidine
- inability to complete 24 hour stay for monitoring
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (1)
Unknown Facility
San Diego, California, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice President, Medical Affairs
- Organization
- Allergan, Inc.
Study Officials
- STUDY DIRECTOR
Medical Affairs
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 6, 2007
First Posted
April 9, 2007
Study Start
December 1, 2006
Primary Completion
February 1, 2009
Study Completion
February 1, 2009
Last Updated
November 24, 2011
Results First Posted
November 24, 2011
Record last verified: 2011-10