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Safety and Efficacy of a New Formulation of Bimatoprost/Timolol Ophthalmic Solution Compared With Bimatoprost/Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01177098
First received: August 4, 2010
Last updated: March 22, 2013
Last verified: March 2013
History of Changes
Results First Received: February 7, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Glaucoma
Ocular Hypertension
Interventions: Drug: bimatoprost /timolol formulation A fixed combination ophthalmic solution
Drug: bimatoprost/timolol fixed combination ophthalmic solution

  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
Bimatoprost/Timolol Formulation A One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
Bimatoprost/Timolol Fixed Combination Ophthalmic Solution One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.

Participant Flow:   Overall Study
    Bimatoprost/Timolol Formulation A     Bimatoprost/Timolol Fixed Combination Ophthalmic Solution  
STARTED     278     283  
COMPLETED     269     271  
NOT COMPLETED     9     12  



  Baseline Characteristics
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Reporting Groups
  Description
Bimatoprost/Timolol Formulation A One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
Bimatoprost/Timolol Fixed Combination Ophthalmic Solution One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
Total Total of all reporting groups

Baseline Measures
    Bimatoprost/Timolol Formulation A     Bimatoprost/Timolol Fixed Combination Ophthalmic Solution     Total  
Number of Participants  
[units: participants]
 		  278     283     561  
Age, Customized  
[units: Participants]
 		     
<45 Years     12     13     25  
45 to 65 Years     132     135     267  
>65 Years     134     135     269  
Gender  
[units: Participants]
 		     
Female     159     162     321  
Male     119     121     240  



  Outcome Measures
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1.  Primary:   Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12   [ Time Frame: Baseline, Week 12 ]
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2.  Primary:   Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 2   [ Time Frame: Week 2 ]
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3.  Primary:   Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 6   [ Time Frame: Week 6 ]
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4.  Primary:   Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12   [ Time Frame: Week 12 ]
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5.  Secondary:   Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12   [ Time Frame: Baseline, Week 12 ]
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6.  Secondary:   Change From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12   [ Time Frame: Baseline, 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: Therapeutic Area Head,
Organization: Allergan, Inc
phone: 714-246-4500
e-mail: clinicaltrials@allergan.com


No publications provided


Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01177098     History of Changes
Other Study ID Numbers: 192024-050, 2010-021507-24
Study First Received: August 4, 2010
Results First Received: February 7, 2013
Last Updated: March 22, 2013
Health Authority: United States: Food and Drug Administration