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

Tracking Information

• First Submitted Date: October 6, 2011
• First Posted Date: October 7, 2011
• Results First Submitted Date: April 5, 2013
• Results First Posted Date: May 22, 2013
• Last Update Posted Date: May 22, 2013
• Study Start Date: October 2011
• Actual Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 5, 2013)

Percentage of Participants Who Are Satisfied or Very Satisfied With Their Eyelashes Overall [ Time Frame: Week 16 ]

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.

• Original Primary Outcome Measures (submitted: October 6, 2011): Percentage of Subjects Who Are Satisfied or Very Satisfied with Their Eyelashes Overall Using a 5-Point Scale [ Time Frame: Week 16 ]

Current Secondary Outcome Measures (submitted: April 5, 2013)

Percentage of Participants With at Least a 1-Grade Increase in the Global Eyelash Assessment (GEA) Score [ Time Frame: Baseline, Week 16 ]

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.

• Original Secondary Outcome Measures (submitted: October 6, 2011): Change from Baseline in Global Eyelash Assessment (GEA) Score [ Time Frame: Baseline, Week 16 ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study Assessing Patient Satisfaction With LATISSE® for Increasing Eyelash Prominence
• Official Title: Not Provided
• Brief Summary: The purpose of this study is to determine patient satisfaction with LATISSE® treatment for increasing eyelash prominence.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Hypotrichosis

Intervention

• Drug: bimatoprost ophthalmic solution 0.03%
  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.
  Other Name: LATISSE®
• Drug: bimatoprost vehicle solution
  One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.

Study Arms

• Active Comparator: bimatoprost ophthalmic solution 0.03%
  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.
  Intervention: Drug: bimatoprost ophthalmic solution 0.03%
• Placebo Comparator: bimatoprost vehicle solution
  One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
  Intervention: Drug: bimatoprost vehicle solution

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 2, 2012): 88
• Original Estimated Enrollment (submitted: October 6, 2011): 76
• Actual Study Completion Date: April 2012
• Actual Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Have inadequate eyelashes
• Never used prescription eyelash growth products

Exclusion Criteria:

• No visible eyelashes
• Permanent eyeliner or eyelash implants
• Semi-permanent eyelash tint, dye, or extensions within 3 months
• Over-the-counter eyelash growth products within 6 months
• Any disease, infection or abnormality of the eye or area around the eye
• Eye surgery within 3 months, or the anticipated need for eye surgery during the study
• Unable or unwilling to keep contact lenses out during drug application and for 30 minutes after application

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01448525
• Other Study ID Numbers: GMA-LTS-11-002
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Allergan
• Original Responsible Party: Same as current
• Current Study Sponsor: Allergan
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Medical Director; Allergan

• PRS Account: Allergan
• Verification Date: April 2013