Assessing the Efficacy and Tolerability of AZARGA® (Brinzolamide 1%/Timolol 0.5% Fixed Combination) as Replacement Therapy in Patients on Brimonidine 0.2%/Timolol 0.5% Fixed Combination Therapy (COMBIGAN®) in Latin America

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01518244
First received: January 23, 2012
Last updated: February 25, 2014
Last verified: February 2014
Results First Received: February 25, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Glaucoma
Intervention: Drug: Brinzolamide/timolol maleate fixed combination

  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
Participants were recruited from 6 study centers located in South America: Argentina (3), Chile (1), and Mexico (2).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

This reporting group includes all participants who received at least one dose of AZARGA®.


Reporting Groups
  Description
AZARGA® Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks

Participant Flow:   Overall Study
    AZARGA®  
STARTED     50  
COMPLETED     47  
NOT COMPLETED     3  
Adverse Event                 3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis population includes all participants who received AZARGA® and with at least one on-therapy study visit (V2 or V3). Of the 50 enrolled, 1 participant discontinued after V1 and before V2.

Reporting Groups
  Description
AZARGA® Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks

Baseline Measures
    AZARGA®  
Number of Participants  
[units: participants]
  49  
Age  
[units: years]
Mean ± Standard Deviation
  66.67  ± 11.51  
Gender  
[units: participants]
 
Female     30  
Male     19  



  Outcome Measures
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1.  Primary:   Mean Change in Intraocular Pressure (IOP) From Baseline (Prior Therapy) at Week 8   [ Time Frame: Baseline, Week 8 ]

2.  Secondary:   Percentage of Subjects Who Reach Target IOP (≤18 mmHg) at Week 8   [ Time Frame: Week 8 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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.


Results Point of Contact:  
Name/Title: Doug Hubatsch, Global Brand Leader, Medical Affairs
Organization: Alcon Research, Ltd.
phone: 1-888-451-3937
e-mail: alcon.medinfo@alcon.com


No publications provided


Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01518244     History of Changes
Other Study ID Numbers: RDG-11-198
Study First Received: January 23, 2012
Results First Received: February 25, 2014
Last Updated: February 25, 2014
Health Authority: Mexico: Ethics Committee
Argentina: Human Research Bioethics Committee
Chile: Institutional Review Board