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CompletedNCT01698554Updated Feb 10, 2015Results posted

Bimatoprost in the Treatment of Eyelash Hypotrichosis

A Phase 3 interventional study of bimatoprost formulation A solution and bimatoprost solution 0.03 % in Idiopathic Eyelash Hypotrichosis, sponsored by Allergan. Completed at 4 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-02-10.

Sponsored by Allergan (part of AbbVie) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
464
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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).

02

Conditions studied

  • Idiopathic Eyelash Hypotrichosis
03

In context

Lead sponsor

Allergan is the lead sponsor of 505 studies on the registry; none are open to participants now.

Of its 93 completed or terminated interventional studies of FDA-regulated products, 91 (98%) have results posted.

First submitted before Allergan became part of AbbVie.

Browse Allergan studies →All AbbVie studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

-Male and female adult patients with eyelash hypotrichosis (inadequate eyelash growth).

Exclusion criteria

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
464 participants (actual)

Study arms

  • Experimental
    bimatoprost formulation A solution

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

    Drug: bimatoprost formulation A solution

  • Active comparator
    bimatoprost solution 0.03 %

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

    Drug: bimatoprost solution 0.03 %

  • Placebo comparator
    vehicle of bimatoprost formulation A solution

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

    Drug: vehicle of bimatoprost formulation A solution

  • Placebo comparator
    vehicle of bimatoprost solution 0.03 %

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

    Drug: vehicle of bimatoprost solution 0.03 %

Interventions

  • Drugbimatoprost formulation A solution

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

  • Drugbimatoprost solution 0.03 %

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

    Also known as: LATISSE®

  • Drugvehicle of bimatoprost formulation A solution

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

  • Drugvehicle of bimatoprost solution 0.03 %

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

06

What researchers measure

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)

    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

  1. 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

  2. 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

  3. 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

  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.

    Time frame: Month 4

07

Results

Posted Feb 10, 2015

Participant flow

Participant flow — Overall Study
MilestoneBimatoprost Formulation A SolutionBimatoprost Solution 0.03 %Vehicle of Bimatoprost Formulation A SolutionVehicle of Bimatoprost Solution 0.03 %
Started1531577579
Completed1471477377
Not completed61022
Withdrew: Adverse event2501
Withdrew: Lost to follow-up1000
Withdrew: Personal reasons0511
Withdrew: Protocol violation2010
Withdrew: Other miscellaneous reasons1000

Outcome measures

PrimaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With at Least a 1-Grade Increase (Improvement) From Baseline in the Investigator's Assessment of Overall Eyelash Prominence (GEA)
percentage of participantsBimatoprost Formulation A SolutionBimatoprost Solution 0.03 %Vehicle of Bimatoprost Formulation A SolutionVehicle of Bimatoprost Solution 0.03 %
Percentage of Participants With at Least a 1-Grade Increase (Improvement) From Baseline in the Investigator's Assessment of Overall Eyelash Prominence (GEA)82.483.424.020.3
SecondaryChange 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
Reported as:
Mean · mm
Change From Baseline in Upper Eyelash Length as Measured Using Digital Image Analysis (DIA)
mmBimatoprost Formulation A SolutionBimatoprost Solution 0.03 %Vehicle of Bimatoprost Formulation A SolutionVehicle of Bimatoprost Solution 0.03 %
Baseline6.09 ± 0.8565.97 ± 0.7895.90 ± 0.8126.03 ± 0.852
Change from Baseline at Month 41.61 ± 0.8881.62 ± 0.9550.08 ± 0.4420.05 ± 0.482
SecondaryChange 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
Reported as:
Mean · mm^2
Change From Baseline in Upper Eyelash Thickness/Fullness as Measured Using DIA
mm^2Bimatoprost Formulation A SolutionBimatoprost Solution 0.03 %Vehicle of Bimatoprost Formulation A SolutionVehicle of Bimatoprost Solution 0.03 %
Baseline0.85 ± 0.4000.82 ± 0.4040.76 ± 0.3330.81 ± 0.380
Change from Baseline At Month 40.58 ± 0.3590.64 ± 0.3920.02 ± 0.1960.03 ± 0.237
SecondaryChange 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
Reported as:
Mean · intensity units
Change From Baseline in Upper Eyelash Intensity (Darkness) as Measured Using DIA
intensity unitsBimatoprost Formulation A SolutionBimatoprost Solution 0.03 %Vehicle of Bimatoprost Formulation A SolutionVehicle of Bimatoprost Solution 0.03 %
Baseline145.33 ± 24.024147.39 ± 24.934147.44 ± 22.323145.79 ± 26.670
Change from Baseline at Month 4-23.98 ± 15.719-24.78 ± 16.417-2.78 ± 10.4430.17 ± 10.065
SecondaryPercentage 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.

Time frame:
Month 4
Reported as:
Number · percentage of participants
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)
percentage of participantsBimatoprost Formulation A SolutionBimatoprost Solution 0.03 %Vehicle of Bimatoprost Formulation A SolutionVehicle of Bimatoprost Solution 0.03 %
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)71.265.028.020.3

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Bimatoprost Formulation A Solution—0/153 (0%)7/153 (4.6%)
Bimatoprost Solution 0.03 %—5/157 (3.2%)8/157 (5.1%)
Vehicle of Bimatoprost Formulation A Solution—1/75 (1.3%)3/75 (4%)
Vehicle of Bimatoprost Solution 0.03 %—1/79 (1.3%)3/79 (3.8%)
Most frequent serious events
Most frequent serious events
EventBimatoprost Formulation A SolutionBimatoprost Solution 0.03 %Vehicle of Bimatoprost Formulation A SolutionVehicle of Bimatoprost Solution 0.03 %
Intervertebral disc protrusionMusculoskeletal and connective tissue disorders0/1530/1571/750/79
MenorrhagiaReproductive system and breast disorders0/1500/1530/751/79
Hiatus herniaGastrointestinal disorders0/1531/1570/750/79
CellulitisInfections and infestations0/1531/1570/750/79
Meningitis viralInfections and infestations0/1531/1570/750/79
PneumoniaInfections and infestations0/1531/1570/750/79
Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/1531/1570/750/79
Most frequent other events
Most frequent other events
EventBimatoprost Formulation A SolutionBimatoprost Solution 0.03 %Vehicle of Bimatoprost Formulation A SolutionVehicle of Bimatoprost Solution 0.03 %
Intraocular pressure decreasedInvestigations7/1538/1573/753/79

Baseline characteristics

Age, Customized
Age, Customized(Participants)Bimatoprost Formulation A SolutionBimatoprost Solution 0.03 %Vehicle of Bimatoprost Formulation A SolutionVehicle of Bimatoprost Solution 0.03 %Total
<45 years2734161592
45 to 65 years1041064755312
>65 years221712960
Sex: Female, Male
Sex: Female, Male(Participants)Bimatoprost Formulation A SolutionBimatoprost Solution 0.03 %Vehicle of Bimatoprost Formulation A SolutionVehicle of Bimatoprost Solution 0.03 %Total
Female1501537579457
Male34007
08

Study locations

4 sites
  • Newport Beach, California, United States
  • Saint Petersburg, Russia
  • Stockholm, Sweden
  • Norfolk, England, United Kingdom
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2012, a primary completion of Feb 2014 and a completion of Mar 2014. It does not say whether these dates are actual or estimated.

Results were first posted in Feb 2015, 1 year after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 1, 2012
First posted
Oct 3, 2012
Start
Nov 2012
Primary completionActual
Feb 2014
CompletionActual
Mar 2014
Results first posted
Feb 10, 2015
Last update
Feb 10, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 10, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01698554
Lead sponsor
Allergan
Responsible party
Sponsor
First posted
Oct 3, 2012
Start date
Nov 2012
Primary completion
Feb 2014
Completion
Mar 2014
Results posted
Feb 10, 2015
Last update
Feb 10, 2015

Study contacts

Medical Director
study director · Allergan

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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