Safety and Efficacy of Bimatoprost Ophthalmic Solution in Increasing Eyelash Prominence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01064882
First received: February 5, 2010
Last updated: November 7, 2011
Last verified: November 2011
Results First Received: August 18, 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
Condition: Eyelash Hypotrichosis
Interventions: Drug: bimatoprost ophthalmic solution 0.005%
Drug: bimatoprost ophthalmic solution 0.015%
Drug: bimatoprost ophthalmic solution 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 Ophthalmic Solution 0.005% bimatoprost ophthalmic sterile solution 0.005%
Bimatoprost Ophthalmic Solution 0.015% bimatoprost ophthalmic sterile solution 0.015%
Bimatoprost Ophthalmic Solution 0.03% bimatoprost ophthalmic solution 0.03%

Participant Flow:   Overall Study
    Bimatoprost Ophthalmic Solution 0.005%     Bimatoprost Ophthalmic Solution 0.015%     Bimatoprost Ophthalmic Solution 0.03%  
STARTED     36     34     34  
COMPLETED     34     32     32  
NOT COMPLETED     2     2     2  



  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 Ophthalmic Solution 0.005% bimatoprost ophthalmic sterile solution 0.005%
Bimatoprost Ophthalmic Solution 0.015% bimatoprost ophthalmic sterile solution 0.015%
Bimatoprost Ophthalmic Solution 0.03% bimatoprost ophthalmic solution 0.03%
Total Total of all reporting groups

Baseline Measures
    Bimatoprost Ophthalmic Solution 0.005%     Bimatoprost Ophthalmic Solution 0.015%     Bimatoprost Ophthalmic Solution 0.03%     Total  
Number of Participants  
[units: participants]
  36     34     34     104  
Age  
[units: years]
Mean ( Full Range )
  46.9  
  ( 32 to 55 )  
  45.4  
  ( 33 to 55 )  
  46.7  
  ( 31 to 55 )  
  46.3  
  ( 31 to 55 )  
Gender  
[units: participants]
       
Female     36     34     34     104  
Male     0     0     0     0  



  Outcome Measures
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1.  Primary:   Change From Baseline in Eyelash Length at Month 3   [ Time Frame: Baseline, Month 3 ]

2.  Secondary:   Change From Baseline in Upper Eyelash Thickness at Month 3   [ Time Frame: Baseline, Month 3 ]

3.  Secondary:   Change From Baseline in Upper Eyelash Darkness (in Intensity Units) at Month 3   [ Time Frame: Baseline, Month 3 ]

4.  Secondary:   Percentage of Subjects With a Clinical Response in Overall Eyelash Prominence on the Global Eyelash Assessment (GEA) at Month 3   [ Time Frame: Month 3 ]

5.  Secondary:   Change From Baseline in Overall Eyelash Satisfaction at Month 3   [ Time Frame: Baseline, Month 3 ]

6.  Secondary:   Change From Baseline in the Confidence, Attractiveness, and Professionalism (CAP) Domain Scores at Month 3   [ Time Frame: Baseline, Month 3 ]

7.  Secondary:   Treatment Satisfaction Questionnaire Score at Month 3   [ Time Frame: Month 3 ]


  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: NCT01064882     History of Changes
Other Study ID Numbers: 192024-051
Study First Received: February 5, 2010
Results First Received: August 18, 2011
Last Updated: November 7, 2011
Health Authority: United States: Food and Drug Administration