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A Study of the Safety and Efficacy of Bimatoprost in Patients With Glaucoma or Ocular Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00538304
First received: September 28, 2007
Last updated: September 19, 2011
Last verified: September 2011
History of Changes
Results First Received: September 19, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Glaucoma
Ocular Hypertension
Interventions: Drug: bimatoprost eye drops
Drug: placebo

  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 Eye Drops Bimatoprost eye drops
Placebo Placebo

Participant Flow:   Overall Study
    Bimatoprost Eye Drops     Placebo  
STARTED     151     71  
COMPLETED     144     66  
NOT COMPLETED     7     5  



  Baseline Characteristics
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Reporting Groups
  Description
Bimatoprost Eye Drops Bimatoprost eye drops
Placebo Placebo
Total Total of all reporting groups

Baseline Measures
    Bimatoprost Eye Drops     Placebo     Total  
Number of Participants  
[units: participants]
 		  151     71     222  
Age, Customized  
[units: participants]
 		     
< 45 years     9     2     11  
Between 45 and 65 years     66     32     98  
> 65 years     76     37     113  
Gender  
[units: participants]
 		     
Female     91     44     135  
Male     60     27     87  



  Outcome Measures
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1.  Primary:   Change From Baseline in Mean Peak Macroscopic Conjunctival Hyperemia at Month 1   [ Time Frame: Baseline, Month 1 ]
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2.  Secondary:   Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye at Month 1   [ Time Frame: Month 1 ]
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3.  Secondary:   Change From Baseline in Mean Intraocular Pressure (IOP) at Month 1   [ Time Frame: Baseline, Month 1 ]
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4.  Secondary:   Percentage of Physicians Who Were Very or Extremely Willing to Continue Patient on Drug, if Drug Were Marketed at Month 1   [ Time Frame: Month 1 ]
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5.  Secondary:   Percentage of Patients Who Were Very or Extremely Willing to Use This Glaucoma Medication at Month 1   [ Time Frame: Month 1 ]
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6.  Secondary:   Percentage of Patients Who Reported No Change in the Appearance of Their Eyes Since the Beginning of the Study at Month 1   [ Time Frame: Month 1 ]
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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: NCT00538304     History of Changes
Other Study ID Numbers: 192024-035
Study First Received: September 28, 2007
Results First Received: September 19, 2011
Last Updated: September 19, 2011
Health Authority: United States: Food and Drug Administration