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A 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
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma, Open-Angle

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
December 2, 2013
Last Updated
June 24, 2014
Sponsor
Allergan
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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

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