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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01830140
First received: April 10, 2013
Last updated: April 21, 2015
Last verified: April 2015
Results First Received: April 21, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Glaucoma
Ocular Hypertension
Interventions: Drug: Bimatoprost 0.01%
Drug: Bimatoprost 0.03%

  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 0.01% Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.
Bimatoprost 0.03% Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.

Participant Flow:   Overall Study
    Bimatoprost 0.01%     Bimatoprost 0.03%  
STARTED     233     233  
COMPLETED     226     229  
NOT COMPLETED     7     4  



  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.
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Reporting Groups
  Description
Bimatoprost 0.01% Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.
Bimatoprost 0.03% Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.
Total Total of all reporting groups

Baseline Measures
    Bimatoprost 0.01%     Bimatoprost 0.03%     Total  
Number of Participants  
[units: participants]
  233     233     466  
Age, Customized  
[units: Participants]
     
< 45 years     6     7     13  
Between 45 and 65 years     91     97     188  
≥65 years     136     129     265  
Gender  
[units: Participants]
     
Female     141     158     299  
Male     92     75     167  



  Outcome Measures

1.  Primary:   Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye   [ Time Frame: Baseline, 6 Weeks ]


  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:  
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.


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: NCT01830140     History of Changes
Other Study ID Numbers: 192024-081
Study First Received: April 10, 2013
Results First Received: April 21, 2015
Last Updated: April 21, 2015
Health Authority: United States: Food and Drug Administration