Study Assessing Patient Satisfaction With LATISSE® for Increasing Eyelash Prominence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01448525
First received: October 6, 2011
Last updated: April 5, 2013
Last verified: April 2013
  Purpose

The purpose of this study is to determine patient satisfaction with LATISSE® treatment for increasing eyelash prominence.


Condition Intervention Phase
Hypotrichosis
Drug: bimatoprost ophthalmic solution 0.03%
Drug: bimatoprost vehicle solution
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Percentage of Participants Who Are Satisfied or Very Satisfied With Their Eyelashes Overall [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Percentage of Participants With at Least a 1-Grade Increase in the Global Eyelash Assessment (GEA) Score [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    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.


Enrollment: 88
Study Start Date: October 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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®
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01448525

Locations
United States, Florida
Coral Gables, Florida, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01448525     History of Changes
Other Study ID Numbers: GMA-LTS-11-002
Study First Received: October 6, 2011
Results First Received: April 5, 2013
Last Updated: April 5, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypotrichosis
Hair Diseases
Skin Diseases
Bimatoprost
Cloprostenol
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014