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AZARGA Transition Study in Taiwan for Patients With Uncontrolled Intraocular Pressure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01484951
First received: December 1, 2011
Last updated: April 25, 2013
Last verified: April 2013
History of Changes
Results First Received: March 12, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Glaucoma
Intervention: Drug: Brinzolamide 1% and timolol 0.5% fixed combination eye drops

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from 3 study centers in Taiwan.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
AZARGA Brinzolamide 1% and timolol 0.5% fixed combination eye drops, one drop administered to the study eye(s) twice daily (8:00 am and 8:00 pm) for up to 8 weeks.

Participant Flow:   Overall Study
    AZARGA  
STARTED     74  
COMPLETED     69  
NOT COMPLETED     5  
Adverse Event                 3  
Personal Reasons                 1  
Non-Compliance                 1  



  Baseline Characteristics
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Reporting Groups
  Description
AZARGA Brinzolamide 1% and timolol 0.5% fixed combination eye drops, one drop administered to the study eye(s) twice daily (8:00 am and 8:00 pm) for up to 8 weeks.

Baseline Measures
    AZARGA  
Number of Participants  
[units: participants]
 		  74  
Age  
[units: years]
Mean ± Standard Deviation 		  60  ± 15  
Gender  
[units: participants]
 		 
Female     42  
Male     32  
Region of Enrollment  
[units: participants]
 		 
Taiwan     74  



  Outcome Measures
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1.  Primary:   Change in Intraocular Pressure (IOP) at the Final Visit From Prior Beta-blocker Monotherapy (Timolol 0.5% Only)   [ Time Frame: Baseline, Week 8 ]
  Show Outcome Measure 1

2.  Secondary:   Percentage of Patients With Target IOP (≤18 mmHg), Regardless of Prior Therapy   [ Time Frame: Week 8 ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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.
The agreement is:
unchecked The only 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 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Abayomi Ogundele, Pharm.D
Organization: Alcon Global Medical Affairs
phone: 1-888-451-3937


No publications provided


Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01484951     History of Changes
Other Study ID Numbers: SMA-10-11
Study First Received: December 1, 2011
Results First Received: March 12, 2013
Last Updated: April 25, 2013
Health Authority: Taiwan: Institutional Review Board