Back to resultsA Study of 0.15% Brimonidine Tartrate in Patients With Primary Open Angle Glaucoma and Ocular Hypertension (APOTUS)
Primary Purpose
Glaucoma, Open-Angle, Ocular Hypertension
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
0.15% Brimonidine Tartrate
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma, Open-Angle
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of open-angle glaucoma or ocular hypertension
Exclusion Criteria:
- Used Alphagan® in previous 3 months
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
0.15% Brimonidine Tartrate
Arm Description
0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.
Outcomes
Primary Outcome Measures
Change From Baseline in Intraocular Pressure (IOP) in the Study Eye
IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02003534
Brief Title
A Study of 0.15% Brimonidine Tartrate in Patients With Primary Open Angle Glaucoma and Ocular Hypertension
Acronym
APOTUS
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate 0.15% brimonidine tartrate in patients with primary open angle glaucoma and ocular hypertension.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open-Angle, 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
376 (Actual)
8. Arms, Groups, and Interventions
Arm Title
0.15% Brimonidine Tartrate
Arm Type
Experimental
Arm Description
0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.
Intervention Type
Drug
Intervention Name(s)
0.15% Brimonidine Tartrate
Other Intervention Name(s)
Alphagan® P
Intervention Description
0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.
Primary Outcome Measure Information:
Title
Change From Baseline in Intraocular Pressure (IOP) in the Study Eye
Description
IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).
Time Frame
Baseline, Month 3
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of open-angle glaucoma or ocular hypertension
Exclusion Criteria:
Used Alphagan® in previous 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Shanghai
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Study of 0.15% Brimonidine Tartrate in Patients With Primary Open Angle Glaucoma and Ocular Hypertension
We'll reach out to this number within 24 hrs