Safety and Efficacy Study of Bimatoprost in Japanese Patients With Eyelash Hypotrichosis

Phase 3

Completed

• Conditions: Eyelash Hypotrichosis
• Interventions: Drug: bimatoprost vehicle solution; Drug: bimatoprost solution 0.03%

• Registration Number: NCT01391273
• Lead Sponsor: Allergan

Brief Summary

This study will evaluate the safety and efficacy of bimatoprost solution 0.03% compared with vehicle in Japanese adults with hypotrichosis of the eyelashes.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-01
• Study First Submitted: 2011-07-08
• Study First Submitted QC: 2011-07-08
• Study First Posted: 2011-07-12
• Primary Completion: 2012-05-19
• Study Completion: 2012-05-19
• Results First Submitted: 2013-05-21
• Results First Submitted QC: 2013-05-21
• Results First Posted: 2013-07-09
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-17
• Last Update Posted: 2019-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 173

Inclusion Criteria

• Have inadequate eyelashes

Exclusion Criteria

• Any disease/infection/abnormality of the eye or area around the eye
• Any ocular surgery within 3 months or anticipated need for ocular surgery during the study
• Any permanent eyeliner or implants of any kind or anticipated use of false eyelashes
• Any semi-permanent eyelash tint, dye, curl or eyelash extension application within 3 months
• Use of any over-the-counter eyelash growth product within 6 months or any use of prescription eyelash growth products
• Use of treatments which may affect hair growth (eg, minoxidil, chemotherapy) within 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bimatoprost vehicle solution	bimatoprost vehicle solution	One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
bimatoprost solution 0.03%	bimatoprost solution 0.03%	One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With at Least a 1-Grade Increase in Overall Eyelash Prominence Using the Global Eyelash Assessment Scale (GEA)	Baseline, Month 4	The investigator evaluated the patient's eyelash prominence using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked at Baseline and Month 4. At least a 1-grade increase in the GEA score from Baseline indicated improvement.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Eyelash Length as Measured by Digital Image Analysis (DIA)	Baseline, Month 4	Photographs were taken of the eyelashes and assessed using DIA. Length was measured in millimeters (mm). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated longer length (improvement).
Change From Baseline in Eyelash Thickness as Measured by DIA	Baseline, Month 4	Photographs were taken of the eyelashes and assessed using DIA. Eyelash thickness (fullness) was assessed across both eyes as an average and is measured in millimeters squared (mm\^2). A positive change from Baseline indicated fuller eyelashes (improvement).
Change From Baseline in Eyelash Darkness as Measured by DIA	Baseline, Month 4	Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white. A negative change from Baseline indicated darker eyelashes (improvement).