Skip to main content
OpenTrials
Completed

NCT Number: NCT01698554

Bimatoprost in the Treatment of Eyelash Hypotrichosis

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Idiopathic Eyelash Hypotrichosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Saint Petersburg, Russia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

bimatoprost formulation A solution

Drug

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.

Other names: LATISSE®

vehicle of bimatoprost formulation A solution

Drug

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

vehicle of bimatoprost solution 0.03 %

Drug

Vehicle of bimatoprost solution 0.03 % applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.

Primary outcomes

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

    Time frame: Baseline, Month 4

    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.

Secondary outcomes

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

    Time frame: 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)

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

    Time frame: Baseline Month 4

    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).

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

    Time frame: Baseline, Month 4

    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).

  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)

    Time frame: Month 4

    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.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 3, 2012
Registry last updated
Feb 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.