Efficacy and Tolerability of AZARGA® as Replacement Therapy in Patients on COMBIGAN® Therapy in Canada

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01415401
First received: August 10, 2011
Last updated: May 30, 2014
Last verified: May 2014
Results First Received: May 30, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Glaucoma
Ocular Hypertension
Open-angle Glaucoma
Intervention: Drug: Brinzolamide 1% / timolol 0.5% 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 8 study centers located in Canada.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 57 enrolled, 3 participants were exited as screen failures. This reporting group includes all participants who received study medication (54).

Reporting Groups
  Description
AZARGA Brinzolamide 1% / timolol 0.5% maleate fixed combination, 1 drop self-administered in study eye(s) twice daily for 8 weeks (8AM and 8PM)

Participant Flow:   Overall Study
    AZARGA  
STARTED     54  
COMPLETED     47  
NOT COMPLETED     7  
Adverse Event                 5  
DId not meet inclusion/exclusion criteri                 1  
Terminated by Sponsor                 1  



  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.
This analysis population includes all participants who received study medication.

Reporting Groups
  Description
AZARGA Brinzolamide 1% / timolol 0.5% maleate fixed combination, 1 drop self-administered in study eye(s) twice daily for 8 weeks (8AM and 8PM)

Baseline Measures
    AZARGA  
Number of Participants  
[units: participants]
  54  
Age  
[units: years]
Mean ± Standard Deviation
  69.6  ± 10.37  
Gender  
[units: participants]
 
Female     28  
Male     26  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in IOP at the Final Visit From Prior Brimonidine 0.2%/Timolol 0.5% Fixed Combination (COMBIGAN®) Therapy (i.e. From Baseline)   [ Time Frame: Baseline, Week 8 ]

2.  Secondary:   Percentage of Subjects Who Reach Target IOP (≤ 18 mmHg)   [ 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
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: NCT01415401     History of Changes
Other Study ID Numbers: RDG-11-199
Study First Received: August 10, 2011
Results First Received: May 30, 2014
Last Updated: May 30, 2014
Health Authority: Canada: Ethics Review Committee