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Trial record 18 of 152 for:    Brimonidine

A Study of 0.15% Brimonidine Tartrate in Patients With Primary Open Angle Glaucoma and Ocular Hypertension (APOTUS)

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ClinicalTrials.gov Identifier: NCT02003534
Recruitment Status : Completed
First Posted : December 6, 2013
Results First Posted : July 22, 2014
Last Update Posted : July 22, 2014
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Glaucoma, Open-Angle
Ocular Hypertension
Intervention Drug: 0.15% Brimonidine Tartrate
Enrollment 376
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 0.15% Brimonidine Tartrate
Hide Arm/Group Description 0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.
Period Title: Overall Study
Started 376
Completed 329
Not Completed 47
Reason Not Completed
Lost to Follow-up             47
Arm/Group Title 0.15% Brimonidine Tartrate
Hide Arm/Group Description 0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.
Overall Number of Baseline Participants 376
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 376 participants
49.8  (17.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 376 participants
Female
161
  42.8%
Male
215
  57.2%
1.Primary Outcome
Title Change From Baseline in Intraocular Pressure (IOP) in the Study Eye
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat: patients with baseline data and data at the indicated time point
Arm/Group Title 0.15% Brimonidine Tartrate
Hide Arm/Group Description:
0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.
Overall Number of Participants Analyzed 376
Mean (Standard Deviation)
Unit of Measure: Millimeters of Mercury (mmHg)
Baseline 25.4  (2.3)
Change from Baseline at Month 3 (N=330) -6.3  (3.5)
Time Frame [Not Specified]
Adverse Event Reporting Description The Safety Set included all treated patients and was used to evaluate adverse events (AEs) and serious adverse events (SAEs).
 
Arm/Group Title 0.15% Brimonidine Tartrate
Hide Arm/Group Description 0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.
All-Cause Mortality
0.15% Brimonidine Tartrate
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
0.15% Brimonidine Tartrate
Affected / at Risk (%)
Total   0/372 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
0.15% Brimonidine Tartrate
Affected / at Risk (%)
Total   24/372 (6.45%) 
Eye disorders   
Conjunctiva Hyperemia   24/372 (6.45%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Name/Title: Vice President Medical Affairs,
Organization: Allergan, Inc
Phone: 714-246-4500
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02003534     History of Changes
Other Study ID Numbers: CN-BRI-1002
First Submitted: December 2, 2013
First Posted: December 6, 2013
Results First Submitted: June 24, 2014
Results First Posted: July 22, 2014
Last Update Posted: July 22, 2014