Safety and Efficacy of Bimatoprost Solution in Increasing Overall Eyelash Prominence

This study has been completed.

Study NCT00693420 Information provided by Allergan

First Received on June 5, 2008. Last Updated on March 26, 2009 History of Changes

Results First Received: January 14, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
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
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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 0.03% 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 [ Time Frame: Week 16 ]

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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) [ Time Frame: Week 20 ]

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3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

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

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6. Secondary:

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

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7. Secondary:

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

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8. Secondary:

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

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9. Other Pre-specified:

Patient Reported Outcome: Overall Satisfaction With Eyelashes (Single Item) in Terms of Change From Baseline to Week 16 [ Time Frame: Week 16 ]

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10. Other Pre-specified:

Patient Reported Outcome: Overall Satisfaction With Eyelashes (Single Item) in Terms of Change From Baseline to Week 20 (Post-treatment) [ Time Frame: Week 20 ]

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: At least ninety (90) days prior to any proposed submission for publication or presentation of Study data or other findings related to the Study, the Institution will provide the Sponsor with a manuscript of such submission(s) for review and comment.

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