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Study Assessing Patient Satisfaction With LATISSE® for Increasing Eyelash Prominence

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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:
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bimatoprost Ophthalmic Solution 0.03% Bimatoprost Vehicle Solution
Hide 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
Arm/Group Title Bimatoprost Ophthalmic Solution 0.03% Bimatoprost Vehicle Solution Total
Hide 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
Hide 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%
1.Primary Outcome
Title Percentage of Participants Who Are Satisfied or Very Satisfied With Their Eyelashes Overall
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
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
Hide 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   --/--   --/-- 
Show Serious Adverse Events Hide 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%) 
Show Other (Not Including Serious) Adverse Events Hide 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
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
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01448525     History of Changes
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