Efficacy and Safety Study of Brinzolamide 1%/Brimonidine 0.2% vs. Brinzolamide 1% and Brimonidine 0.2%

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01297517
First received: February 15, 2011
Last updated: May 14, 2013
Last verified: May 2013
Results First Received: March 27, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Open-Angle Glaucoma
Ocular Hypertension
Interventions: Drug: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension
Drug: Brinzolamide ophthalmic suspension, 1%
Drug: Brimonidine tartrate ophthalmic solution, 0.2%

  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 68 study centers in the US.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 1001 enrolled, 341 subjects did not qualify for treatment and were exited without exposure to product. The 660 subjects eligible for treatment were randomized (1:1:1) to study drug. This reporting group includes all randomized subjects, as treated.

Reporting Groups
  Description
Brinzolamide/Brimonidine Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
Brinzolamide Brinzolamide ophthalmic suspension, 1%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
Brimonidine Brimonidine tartrate ophthalmic solution, 0.2%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months

Participant Flow:   Overall Study
    Brinzolamide/Brimonidine     Brinzolamide     Brimonidine  
STARTED     214     226     220  
COMPLETED     187     214     193  
NOT COMPLETED     27     12     27  
Adverse Event                 21                 7                 16  
Lost to Follow-up                 1                 0                 1  
Patient Decision Unrelated to AE                 2                 3                 7  
Noncompliance                 1                 0                 0  
Protocol Violation                 1                 1                 1  
Inadequate Control of IOP                 1                 1                 2  



  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 reporting group includes all participants randomized to study drug, as treated.

Reporting Groups
  Description
Brinzolamide/Brimonidine Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
Brinzolamide Brinzolamide ophthalmic suspension, 1%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
Brimonidine Brimonidine tartrate ophthalmic solution, 0.2%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
Total Total of all reporting groups

Baseline Measures
    Brinzolamide/Brimonidine     Brinzolamide     Brimonidine     Total  
Number of Participants  
[units: participants]
  214     226     220     660  
Age, Customized  
[units: participants]
       
18 to 64 years     107     101     117     325  
≥65 years     107     125     103     335  
Gender  
[units: participants]
       
Female     140     128     135     403  
Male     74     98     85     257  



  Outcome Measures

1.  Primary:   Mean IOP at Month 3 for Each Assessment Timepoint (8 AM, + 2 h, + 7 h, and + 9 h)   [ Time Frame: Month 3 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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: Matt Walker, PhD, Clinical Project Lead
Organization: Alcon Research, Ltd.
phone: 1-888-451-3937
e-mail: alcon.medinfo@alcon.com


No publications provided by Alcon Research

Publications automatically indexed to this study:

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01297517     History of Changes
Other Study ID Numbers: C-10-033
Study First Received: February 15, 2011
Results First Received: March 27, 2013
Last Updated: May 14, 2013
Health Authority: United States: Food and Drug Administration