Study Assessing Patient Satisfaction With LATISSE® for Increasing Eyelash Prominence

NCT01448525 | Completed Phase 4 Results

• 1 other identifier: GMA-LTS-11-002
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypotrichosis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Are Satisfied or Very Satisfied With Their Eyelashes Overall

  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.

  Week 16

Secondary Outcomes (1)

• Percentage of Participants With at Least a 1-Grade Increase in the Global Eyelash Assessment (GEA) Score

  Baseline, Week 16

Study Arms (2)

bimatoprost ophthalmic solution 0.03%

ACTIVE COMPARATOR

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%

bimatoprost vehicle solution

PLACEBO COMPARATOR

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

Interventions

bimatoprost ophthalmic solution 0.03% DRUG

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.

Also known as: LATISSE®

bimatoprost ophthalmic solution 0.03%

bimatoprost vehicle solution DRUG

One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.

bimatoprost vehicle solution

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have inadequate eyelashes
• Never used prescription eyelash growth products

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Coral Gables, Florida, United States

Location

MeSH Terms

Conditions

Hypotrichosis

Interventions

Bimatoprost

Condition Hierarchy (Ancestors)

Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Results Point of Contact

• Title: Therapeutic Area Head,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2011
• First Posted: October 7, 2011
• Study Start: October 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: May 22, 2013
• Results First Posted: May 22, 2013

Record last verified: 2013-04

Locations

US (1)