Bimatoprost in the Treatment of Eyelash Hypotrichosis

Allergan464 enrolled

Overview

This study will evaluate the safety and efficacy of bimatoprost solution formulation A compared with bimatoprost solution 0.03% (LATISSE®) and vehicle in the treatment of eyelash hypotrichosis (inadequate eyelashes).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

464

Conditions

Idiopathic Eyelash Hypotrichosis

Interventions

bimatoprost formulation A solutionDRUG

Bimatoprost formulation A solution applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.

bimatoprost solution 0.03 %DRUG

Bimatoprost solution 0.03 % (LATISSE®) applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.

vehicle of bimatoprost formulation A solutionDRUG

Vehicle of bimatoprost formulation A solution applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: -Male and female adult patients with eyelash hypotrichosis (inadequate eyelash growth). Exclusion Criteria: * Damage to eyelid area (scarring) that may prevent growth of eyelashes * Active eye diseases (glaucoma, uveitis, eye infections, chronic blepharitis or severe dry eye) * Eye or eyelid surgery (including laser, refractive, intraocular filtering surgery, blepharoplasty) during the 3 months prior to screening * Current eyelash implants of any kind * Eyelash tint or dye application within 2 months of baseline * Eyelash extensions application within 3 months of baseline * Use of eyelash growth products within 6 months of baseline * Treatments that may affect hair growth (minoxidil, cancer chemotherapeutic agents, etc) within 6 months prior to baseline.

Locations (4)

Unnamed facility

Newport Beach, California, United States

Unnamed facility

Saint Petersburg, Russia

Unnamed facility

Stockholm, Sweden

Unnamed facility

Norfolk, England, United Kingdom

Outcomes

Primary Outcomes

Percentage of Participants With at Least a 1-Grade Increase (Improvement) From Baseline in the Investigator's Assessment of Overall Eyelash Prominence (GEA)

The investigator evaluated the overall eyelash prominence in both eyes using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked. A 1-grade improvement in the GEA score from Baseline indicated improvement.

Time frame: Baseline, Month 4

Secondary Outcomes

Change From Baseline in Upper Eyelash Length as Measured Using Digital Image Analysis (DIA)

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)

Time frame: Baseline, Month 4

Change From Baseline in Upper Eyelash Thickness/Fullness as Measured Using DIA

Photographs were taken of the eyelashes and assessed using DIA. Eyelash thickness (fullness) was measured in millimeters squared (mm\^2). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated fuller eyelashes (improvement).

Time frame: Baseline Month 4

Change From Baseline in Upper Eyelash Intensity (Darkness) as Measured Using DIA

Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness (intensity) 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).

Time frame: Baseline, Month 4

Percentage of Participants Satisfied or Very Satisfied in the Patient's Assessment of Overall Eyelash Satisfaction as Measured by the Eyelash Satisfaction Questionnaire (ESQ-9)

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: 1= very unsatisfied (worst), 2= unsatisfied, 3= neutral, 4= satisfied or 5= very satisfied (best). The percentage of participants who rated their satisfaction as satisfied or very satisfied at Month 4 is reported.

Data from ClinicalTrials.gov

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