Idiopathic Eyelash HypotrichosisPhase 3NCT01698554
Bimatoprost in the Treatment of Eyelash Hypotrichosis
A Phase 3 study testing bimatoprost formulation A solution and bimatoprost solution 0.03 % in people with Idiopathic Eyelash Hypotrichosis, run by Allergan at 4 sites in 4 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Eyelash Hypotrichosis
- What is being tested?
- bimatoprost formulation A solution and bimatoprost solution 0.03 %
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 464 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Nov 2012to Mar 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Male and female adult patients with eyelash hypotrichosis (inadequate eyelash growth).
Who cannot join
- 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.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
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).
- Conditions
- Idiopathic Eyelash Hypotrichosis
- Being tested
- bimatoprost formulation A solution, bimatoprost solution 0.03 %, vehicle of bimatoprost formulation A solution, vehicle of bimatoprost solution 0.03 %
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Also called LATISSE®
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| bimatoprost formulation A solution | Experimental | Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator. Receives: Drug: bimatoprost formulation A solution |
| bimatoprost solution 0.03 % | Active comparator | 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. Receives: Drug: bimatoprost solution 0.03 % |
| vehicle of bimatoprost formulation A solution | Placebo comparator | 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. Receives: Drug: vehicle of bimatoprost formulation A solution |
| vehicle of bimatoprost solution 0.03 % | Placebo comparator | 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. Receives: Drug: vehicle of bimatoprost solution 0.03 % |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Month 4
Secondary outcomes (4)
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)
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionFeb 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Idiopathic Eyelash HypotrichosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 464 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01698554
- Sponsor's protocol ID
- 192024-046
- Other IDs
- 2012-003007-35
- Status last verified
- Jan 2015
- First submitted
- 1 Oct 2012
- Last updated
- 10 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bimatoprost in the Treatment of Eyelash Hypotrichosis
- ClinicalTrials.gov ID
- NCT01698554
- Acronym / sponsor ID
- 192024-046
- Conditions
- Idiopathic Eyelash Hypotrichosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 464 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 3 Oct 2012 (estimated)
- Results
- Posted 10 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| bimatoprost formulation A solution | Experimental | Drug: bimatoprost formulation A solutionBimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator. |
| bimatoprost solution 0.03 % | Active comparator | Drug: 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. |
| vehicle of bimatoprost formulation A solution | Placebo comparator | Drug: vehicle of bimatoprost formulation A solutionVehicle 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. |
| vehicle of bimatoprost solution 0.03 % | Placebo comparator | Drug: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Male and female adult patients with eyelash hypotrichosis (inadequate eyelash growth).
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bimatoprost formulation A solutionBimatoprost formulation A solution applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator. | Drug | bimatoprost formulation A solution |
| bimatoprost solution 0.03 %Also: LATISSE®Bimatoprost solution 0.03 % (LATISSE®) applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator. | Drug | bimatoprost solution 0.03 % |
| vehicle of bimatoprost formulation A solutionVehicle of bimatoprost formulation A solution applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator. | Drug | vehicle of bimatoprost formulation A solution |
| vehicle 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. | Drug | vehicle of bimatoprost solution 0.03 % |
Primary outcome
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.
4 secondary outcomes
Change From Baseline in Upper Eyelash Length as Measured Using Digital Image Analysis (DIA)
Time frame: Baseline, Month 4
Change From Baseline in Upper Eyelash Thickness/Fullness as Measured Using DIA
Time frame: Baseline Month 4
Change From Baseline in Upper Eyelash Intensity (Darkness) as Measured Using DIA
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)
Time frame: Month 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Allergan
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bimatoprost formulation A solution and bimatoprost solution 0.03 % in people with Idiopathic Eyelash Hypotrichosis, run by Allergan at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Russia, Sweden, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2015.