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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01514734
Recruitment Status : Terminated (Low recruitment rate)
First Posted : January 23, 2012
Results First Posted : October 21, 2013
Last Update Posted : October 21, 2013
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Glaucoma
Intervention: Drug: Brinzolamide/timolol maleate fixed combination

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks

Participant Flow:   Overall Study
    AZARGA
STARTED   9 
COMPLETED   9 
NOT COMPLETED   0 



  Baseline Characteristics

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.
No text entered.

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

Baseline Measures
   AZARGA 
Overall Participants Analyzed 
[Units: Participants]
 9 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.56  (15.83) 
Gender 
[Units: Participants]
 
Female   6 
Male   3 
Region of Enrollment 
[Units: Participants]
 
Brazil   9 


  Outcome Measures

1.  Primary:   Change in Intraocular Pressure (IOP) at 8 Weeks From Baseline (Prior Therapy).   [ Time Frame: 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  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
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  More Information

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



Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01514734     History of Changes
Other Study ID Numbers: RDG-11-191
First Submitted: January 18, 2012
First Posted: January 23, 2012
Results First Submitted: August 15, 2013
Results First Posted: October 21, 2013
Last Update Posted: October 21, 2013