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

History of Changes

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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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 ]

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2. Secondary:

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

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3. Secondary:

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

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Measure Type	Secondary
Measure Title	Change From Baseline in Upper Eyelash Darkness (in Intensity Units) at Month 3
Measure Description	Change from baseline in upper eyelash darkness at Month 3 was determined by lash intensity within the spline (a narrow area approximately 5 pixels wide that bisects the area of interest). Upper eyelash darkness was measured in both eyes and averaged for analysis. Colors ranged from black=0 to white=255. Lower numbers on this continuum indicated darker colors. Therefore, a change from baseline to Month 3 represented by a negative value indicated increased eyelash darkening.
Time Frame	Baseline, Month 3
Safety Issue	No

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.
Modified Intent-to-Treat: All randomized (started study) subjects who were treated with the intended study medication and completed at least one follow-up visit. (Note that 2 subjects in the Bim 0.015% treatment group did not have baseline or Month 3 visit data for this outcome measure.)

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%

Measured Values

	Bimatoprost Ophthalmic Solution 0.005%	Bimatoprost Ophthalmic Solution 0.015%	Bimatoprost Ophthalmic Solution 0.03%
Number of Participants Analyzed [units: participants]	36	32	34
Change From Baseline in Upper Eyelash Darkness (in Intensity Units) at Month 3 [units: Units on a Scale] Mean ± Standard Deviation
Baseline	157.14 ± 22.814	154.41 ± 21.065	162.41 ± 17.321
Change from Baseline at Month 3	-18.75 ± 23.276	-26.55 ± 22.505	-29.61 ± 20.443

No statistical analysis provided for Change From Baseline in Upper Eyelash Darkness (in Intensity Units) at 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 ]

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5. Secondary:

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

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6. Secondary:

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

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7. Secondary:

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

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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: A 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 90 days from the time submitted to the sponsor for review. 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:	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

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