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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 
Overall Participants Analyzed 
[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


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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