Study Assessing Patient Satisfaction With LATISSE® for Increasing Eyelash Prominence

• ClinicalTrials.gov Identifier: NCT01448525
• Recruitment Status: Completed
• First Posted: October 7, 2011
• Results First Posted: May 22, 2013
• Last Update Posted: May 22, 2013
• Sponsor: Allergan
• Information provided by (Responsible Party): Allergan

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Hypotrichosis
• Interventions: Drug: bimatoprost ophthalmic solution 0.03%; Drug: bimatoprost vehicle solution
• Enrollment: 88

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Bimatoprost Ophthalmic Solution 0.03%	Bimatoprost Vehicle Solution
Arm/Group Description	One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.	One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
Period Title: Overall Study
Started	44	44
Completed	43	42
Not Completed	1	2

Baseline Characteristics

Arm/Group Title		Bimatoprost Ophthalmic Solution 0.03%	Bimatoprost Vehicle Solution	Total
Arm/Group Description		One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.	One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.	Total of all reporting groups
Overall Number of Baseline Participants		44	44	88
Baseline Analysis Population Description		[Not Specified]
Age Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	44 participants	44 participants	88 participants
		49.2 (12.6)	50.2 (10.5)	49.7 (11.5)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	44 participants	44 participants	88 participants
	Female	44 100.0%	44 100.0%	88 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Who Are Satisfied or Very Satisfied With Their Eyelashes Overall
Description	Participants rated their overall eyelash satisfaction by answering Eyelash Satisfaction Questionnaire (ESQ-9) question #3: "Overall, how satisfied are you with your eyelashes?" using a 5-point scale: -2=very unsatisfied (worst), -1=unsatisfied, 0=neutral, 1=satisfied or 2=very satisfied (best). The percentage of participants who rated their satisfaction as 1=satisfied or 2=very satisfied at Week 16 is reported.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

Intent to treat population included all randomized participants who had at least 1 post-baseline efficacy assessment.

Arm/Group Title	Bimatoprost Ophthalmic Solution 0.03%	Bimatoprost Vehicle Solution
Arm/Group Description:	One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.	One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
Overall Number of Participants Analyzed	43	42
Measure Type: Number; Unit of Measure: Percentage of participants
	67.4	7.1

2. Secondary Outcome

Title	Percentage of Participants With at Least a 1-Grade Increase in the Global Eyelash Assessment (GEA) Score
Description	The investigator evaluated the patient's overall eyelash prominence using the 4-point GEA scale: 1=minimal (worst), 2=moderate, 3=marked or 4=very marked (best). An at least a 1-grade increase in GEA score indicated improvement.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

Intent to treat population included all randomized participants who had at least 1 post-baseline efficacy assessment.

Arm/Group Title	Bimatoprost Ophthalmic Solution 0.03%	Bimatoprost Vehicle Solution
Arm/Group Description:	One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.	One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
Overall Number of Participants Analyzed	43	42
Measure Type: Number; Unit of Measure: Percentage of participants
	72.1	19.0

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	Treatment-emergent adverse events are presented.
Arm/Group Title	Bimatoprost Ophthalmic Solution 0.03%	Bimatoprost Vehicle Solution
Arm/Group Description	One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.	One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
All-Cause Mortality
	Bimatoprost Ophthalmic Solution 0.03%	Bimatoprost Vehicle Solution
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	Bimatoprost Ophthalmic Solution 0.03%	Bimatoprost Vehicle Solution
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/44 (0.00%)	0/44 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Bimatoprost Ophthalmic Solution 0.03%	Bimatoprost Vehicle Solution
	Affected / at Risk (%)	Affected / at Risk (%)
Total	1/44 (2.27%)	3/44 (6.82%)
Infections and infestations
Nasopharyngitis † 1	1/44 (2.27%)	3/44 (6.82%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA 15.1

Limitations and Caveats

[Not Specified]

More Information

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.

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.

Results Point of Contact

• Name/Title: Therapeutic Area Head,
• Organization: Allergan, Inc
• Phone: 714-246-4500
• EMail: clinicaltrials@allergan.com

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT01448525
• Other Study ID Numbers: GMA-LTS-11-002
• First Submitted: October 6, 2011
• First Posted: October 7, 2011
• Results First Submitted: April 5, 2013
• Results First Posted: May 22, 2013
• Last Update Posted: May 22, 2013