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An Evaluation of the Fixed Combination Brimonidine Tartrate 0.2%/ Timolol Maleate 0.5% to Latanoprost 0.005% in Glaucoma or Ocular Hypertension Subjects

This study has been completed.
Sponsor:
Information provided by:
Allergan
ClinicalTrials.gov Identifier:
NCT00811564
First received: December 17, 2008
Last updated: August 17, 2011
Last verified: August 2011
History of Changes
Results First Received: August 17, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Treatment
Conditions: Glaucoma
Ocular Hypertension
Interventions: Drug: fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution
Drug: latanoprost 0.005%

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Fixed Combination of Brimonidine Tartrate 0.2%/Timolol Maleate Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution
Latanoprost 0.005% Ophthalmic Solution Latanoprost 0.005% ophthalmic solution

Participant Flow:   Overall Study
    Fixed Combination of Brimonidine Tartrate 0.2%/Timolol Maleate     Latanoprost 0.005% Ophthalmic Solution  
STARTED     73     75  
COMPLETED     64     73  
NOT COMPLETED     9     2  



  Baseline Characteristics
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Reporting Groups
  Description
Fixed Combination of Brimonidine Tartrate 0.2%/Timolol Maleate Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution
Latanoprost 0.005% Ophthalmic Solution Latanoprost 0.005% ophthalmic solution
Total Total of all reporting groups

Baseline Measures
    Fixed Combination of Brimonidine Tartrate 0.2%/Timolol Maleate     Latanoprost 0.005% Ophthalmic Solution     Total  
Number of Participants  
[units: participants]
 		  73     75     148  
Age  
[units: years]
Median ( Full Range ) 		  65  
  ( 27 to 88 )   		  65  
  ( 33 to 87 )   		  65  
  ( 27 to 88 )  
Gender  
[units: participants]
 		     
Female     42     44     86  
Male     31     31     62  



  Outcome Measures

1.  Primary:   Intraocular Pressure (IOP) at Week 12   [ Time Frame: Week 12 ]
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  Serious Adverse Events
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  Other Adverse Events
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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.


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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Results Point of Contact:  
Name/Title: Vice President Medical Affairs
Organization: Allergan, Inc.
phone: 714-246-4500
e-mail: clinicaltrials@allergan.com


No publications provided by Allergan

Publications automatically indexed to this study:


Responsible Party: Medical Affairs Director, Allergan, Inc.
ClinicalTrials.gov Identifier: NCT00811564     History of Changes
Other Study ID Numbers: GMA-COM-08-008
Study First Received: December 17, 2008
Results First Received: August 17, 2011
Last Updated: August 17, 2011
Health Authority: United States: Institutional Review Board