Safety and Efficacy of Adding AZARGA® Adjunctive to Prostaglandin Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01263444
First received: December 17, 2010
Last updated: May 18, 2014
Last verified: May 2014
Results First Received: April 23, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Glaucoma
Ocular Hypertension
Interventions: Drug: Brinzolamide 1% / timolol 0.5% Fixed Combination
Drug: Habitual prostaglandin monotherapy

  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 3 study centers located in Austria and 2 study centers located in Spain.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This reporting group includes all enrolled participants (47).

Reporting Groups
  Description
Azarga Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.

Participant Flow:   Overall Study
    Azarga  
STARTED     47  
COMPLETED     37  
NOT COMPLETED     10  
Adverse Event                 8  
Withdrawal by Subject                 1  
Protocol Violation                 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 enrolled participants.

Reporting Groups
  Description
Azarga Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.

Baseline Measures
    Azarga  
Number of Participants  
[units: participants]
  47  
Age, Customized  
[units: participants]
 
≤55 Years     3  
56-65 Years     10  
66-75 Years     25  
≥ 76 Years     9  
Gender  
[units: participants]
 
Female     24  
Male     23  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Change From Baseline in Intraocular Pressure (IOP) at Week 12   [ Time Frame: Baseline, Week 12 ]

2.  Secondary:   Mean Change From Baseline in IOP Per Prostaglandin Group at Week 12   [ Time Frame: Baseline, Week 12 ]

3.  Secondary:   Mean Change From Baseline in IOP at Week 4   [ Time Frame: Baseline, Week 4 ]

4.  Secondary:   Percentage of Patients Reaching the Target IOP (≤ 18 mmHg)   [ Time Frame: Week 12 ]


  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
A single-arm, non-randomized study somewhat limits interpretation of efficacy results. A 3-month duration does not allow for long-term safety conclusions; however, data obtained at V2 and V3 did not vary much, indicating a steady state at Month 1.


  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: NCT01263444     History of Changes
Other Study ID Numbers: RDG-10-246, 2010-022948-21
Study First Received: December 17, 2010
Results First Received: April 23, 2014
Last Updated: May 18, 2014
Health Authority: Austria: Ethikkommission
Spain: Comité Ético de Investigación Clínica