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Study Results
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Safety and Efficacy of Bimatoprost Solution in Increasing Overall Eyelash Prominence
This study has been completed.
Study NCT00693420   Information provided by Allergan
First Received: June 5, 2008   Last Updated: March 26, 2009   History of Changes
Study Type: Interventional
Study Design: Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Condition: Eyelashes
Interventions: Drug: Bimatoprost 0.03% sterile solution
Drug: vehicle sterile 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
No text entered.

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 0.03% Solution No text entered.
Vehicle Solution No text entered.

Participant Flow:   Overall Study
  Bimatoprost 0.03% Solution Vehicle Solution
STARTED   137     141  
COMPLETED   131     126  
NOT COMPLETED   6     15  
      Adverse Event               4                 4  
      Lost to Follow-up               0                 3  
      Withdrawal by Subject               1                 0  
      Protocol Violation               0                 2  
      Sponsor Request - Conflict of Interest               0                 2  
      Personal Reasons               1                 4  



  Baseline Characteristics
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Reporting Groups
  Description
Bimatoprost 0.03% Solution No text entered.
Vehicle Solution No text entered.

Baseline Measures
  Bimatoprost 0.03% Solution Vehicle Solution Total
Number of Participants  
[units: participants]
137 141 278
Age, Customized  
[units: participants]
     
<45 years 44 43 87
Between 45 and 65 years 82 88 170
>65 years 11 10 21
Gender  
[units: participants]
     
Female 134 136 270
Male 3 5 8



  Outcome Measures
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1.  Primary:   Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 16   [ Week 16 ]

2.  Primary:   Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 20 (Post-treatment)   [ Week 20 ]

3.  Secondary:   Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16   [ Week 16 ]

4.  Secondary:   Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)   [ Week 20 ]

5.  Secondary:   Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16   [ Week 16 ]

6.  Secondary:   Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)   [ Week 20 ]

7.  Secondary:   Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16   [ Week 16 ]

8.  Secondary:   Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)   [ Week 20 ]

9.  Other Pre-specified:   Patient Reported Outcome: Overall Satisfaction With Eyelashes (Single Item) in Terms of Change From Baseline to Week 16   [ Week 16 ]

10.  Other Pre-specified:   Patient Reported Outcome: Overall Satisfaction With Eyelashes (Single Item) in Terms of Change From Baseline to Week 20 (Post-treatment)   [ Week 20 ]


  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
None  


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, Inc. ( Therapeutic Area Head )
Study ID Numbers: 192024-032
Study First Received: June 5, 2008
Results First Received: January 14, 2009
Last Updated: March 26, 2009
ClinicalTrials.gov Identifier: NCT00693420     History of Changes
Health Authority: United States: Food and Drug Administration