Eyelash HypotrichosisPhase 2NCT01064882
Safety and Efficacy of Bimatoprost Ophthalmic Solution in Increasing Eyelash Prominence
A Phase 2 study testing bimatoprost ophthalmic solution 0.005%, bimatoprost ophthalmic solution 0.015% and bimatoprost ophthalmic solution 0.03% in people with Eyelash Hypotrichosis, run by Allergan at 1 site in United States.
Trial summary
This study will evaluate the safety and efficacy of bimatoprost ophthalmic solution 0.005% or 0.015% compared with bimatoprost ophthalmic solution 0.03% once-daily application to the upper eyelid margins in increasing eyelash prominence Read more about this study
- Who is it for?
- Ages 30 to 55 years, women only
- Conditions the study is for
- Eyelash Hypotrichosis
- What is being tested?
- bimatoprost ophthalmic solution 0.005%, bimatoprost ophthalmic solution 0.015% and bimatoprost ophthalmic solution 0.03%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Jul 2010
- Phase
- Phase 2
- 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 30 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female Caucasians between 30 and 55 years of age, with hypotrichosis (inadequate or not enough) of the eyelashes
- Eyelash prominence assessment of minimal or moderate
Who cannot join
- Any eye disease or abnormality
- Any permanent eyeliner or eyelash implants of any kind
- Any ocular surgery, semi-permanent eyelash tint, or eyelash extension application during the 3 months prior to study entry
- Any use of prescription eyelash growth products
- Any use of over the counter eyelash growth products during the 6 months prior to baseline
- Any use of treatments that may affect hair growth during the 6 months prior to baseline
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate the safety and efficacy of bimatoprost ophthalmic solution 0.005% or 0.015% compared with bimatoprost ophthalmic solution 0.03% once-daily application to the upper eyelid margins in increasing eyelash prominence
- Conditions
- Eyelash Hypotrichosis
- Being tested
- bimatoprost ophthalmic solution 0.005%, bimatoprost ophthalmic solution 0.015%, bimatoprost ophthalmic solution 0.03%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bimatoprost ophthalmic solution 0.005%Drug
One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margins (where the eyelashes meet the skin)
bimatoprost ophthalmic solution 0.015%Drug
One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margins (where the eyelashes meet the skin)
bimatoprost ophthalmic solution 0.03%Drug
Also called LATISSE®
One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margins (where the eyelashes meet the skin)
| Study group | Role | What they receive |
|---|---|---|
| bimatoprost ophthalmic solution 0.005% | Experimental | bimatoprost ophthalmic sterile solution 0.005% Receives: Drug: bimatoprost ophthalmic solution 0.005% |
| bimatoprost ophthalmic solution 0.015% | Experimental | bimatoprost ophthalmic sterile solution 0.015% Receives: Drug: bimatoprost ophthalmic solution 0.015% |
| bimatoprost ophthalmic solution 0.03% | Active comparator | bimatoprost ophthalmic solution 0.03% Receives: Drug: bimatoprost ophthalmic solution 0.03% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Eyelash Length at Month 3
Change from Baseline at Month 3 in eyelash length, measured in millimeters (mm). Data from both eyes were averaged for each subject for analysis. Changes from baseline represented by positive values indicated longer length, and changes from baseline represented by negative values indicated shorter length.
Measured: Baseline, Month 3
Secondary outcomes (6)
Change From Baseline in Upper Eyelash Thickness at Month 3
Change from baseline in upper eyelash thickness/fullness at Month 3 was measured within 3 preset areas. Eyelash thickness/fullness was assessed across both eyes as an average of the 3 preset areas measured in millimeters squared (mm^2). Changes from baseline to Month 3 represented by positive values indicated increased eyelash thickness, and changes from baseline represented by negative values indicated thinner eyelash thickness.
Measured: Baseline, Month 3
Change From Baseline in Upper Eyelash Darkness (in Intensity Units) at Month 3
Change from baseline in upper eyelash darkness at Month 3 was determined by lash intensity within the spline (a narrow area approximately 5 pixels wide that bisects the area of interest). Upper eyelash darkness was measured in both eyes and averaged for analysis. Colors ranged from black=0 to white=255. Lower numbers on this continuum indicated darker colors. Therefore, a change from baseline to Month 3 represented by a negative value indicated increased eyelash darkening.
Measured: Baseline, Month 3
Percentage of Subjects With a Clinical Response in Overall Eyelash Prominence on the Global Eyelash Assessment (GEA) at Month 3
Percentage of subjects with a clinical response in overall eyelash prominence at Month 3 was measured using a 4-point GEA scale with the aid of the photonumeric guide. The scale ranges from 1 (minimal = worst) prominence to 4 (very marked = best)prominence. Eyelash prominence was assessed and graded by the investigator over both eyes. A clinical response was defined as at least a 1-grade increase in GEA score from baseline to Month 3.
Measured: Month 3
Change From Baseline in Overall Eyelash Satisfaction at Month 3
Change from baseline at Month 3 in question 3 "overall, how satisfied are you with your eyelashes?" Responses ranged from 1 (very unsatisfied = worst) to 5 (very satisfied = best). Individual responses at Month 3 were compared to baseline. Positive values at Month 3 indicated an improvement from baseline, and negative values indicated a worsening from baseline.
Measured: Baseline, Month 3
Change From Baseline in the Confidence, Attractiveness, and Professionalism (CAP) Domain Scores at Month 3
Change from baseline in the CAP domain at Month 3 included responses to questions 7, 8, and 9. Responses to each question ranged from 1 (very much disagree = worst) to 5 (very much agree = best) with the minimum sum of the scores for the domain equal to 3 and the maximum sum of the scores for the domain equal to 15. Domain responses at Month 3 were compared to baseline. Positive values at Month 3 indicated an improvement from baseline, and negative values indicated a worsening from baseline.
Measured: Baseline, Month 3
Treatment Satisfaction Questionnaire Score at Month 3
The Treatment Satisfaction Questionnaire at Month 3 consisted of 2 questions that collected information regarding subject satisfaction with the treatment overall. The questions assessed the likelihood that the subject would use the product, as well as the likelihood that the subject would recommend the product to family and/or friends, if it were available. The score was based on the responses to each question. Questions were answered on a 5-point scale ranging from 1 (very unlikely = worst) to 5 (very likely = best).
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionJul 2010
- Study completionJul 2010
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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 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
- NCT01064882
- Sponsor's protocol ID
- 192024-051
- Status last verified
- Nov 2011
- First submitted
- 5 Feb 2010
- Last updated
- 9 Dec 2011
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Bimatoprost Ophthalmic Solution in Increasing Eyelash Prominence
- ClinicalTrials.gov ID
- NCT01064882
- Acronym / sponsor ID
- 192024-051
- Conditions
- Eyelash Hypotrichosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 9 Feb 2010 (estimated)
- Results
- Posted 9 Dec 2011
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 ophthalmic solution 0.005% or 0.015% compared with bimatoprost ophthalmic solution 0.03% once-daily application to the upper eyelid margins in increasing eyelash prominence
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| bimatoprost ophthalmic solution 0.005% | Experimental | Drug: bimatoprost ophthalmic solution 0.005%bimatoprost ophthalmic sterile solution 0.005% |
| bimatoprost ophthalmic solution 0.015% | Experimental | Drug: bimatoprost ophthalmic solution 0.015%bimatoprost ophthalmic sterile solution 0.015% |
| bimatoprost ophthalmic solution 0.03% | Active comparator | Drug: bimatoprost ophthalmic solution 0.03%bimatoprost ophthalmic solution 0.03% |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Female Caucasians between 30 and 55 years of age, with hypotrichosis (inadequate or not enough) of the eyelashes
- Eyelash prominence assessment of minimal or moderate
Key exclusion criteria (6 listed)
- Any eye disease or abnormality
- Any permanent eyeliner or eyelash implants of any kind
- Any ocular surgery, semi-permanent eyelash tint, or eyelash extension application during the 3 months prior to study entry
- Any use of prescription eyelash growth products
- Any use of over the counter eyelash growth products during the 6 months prior to 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 ophthalmic solution 0.005%One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margins (where the eyelashes meet the skin) | Drug | bimatoprost ophthalmic solution 0.005% |
| bimatoprost ophthalmic solution 0.015%One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margins (where the eyelashes meet the skin) | Drug | bimatoprost ophthalmic solution 0.015% |
| bimatoprost ophthalmic solution 0.03%Also: LATISSE®One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margins (where the eyelashes meet the skin) | Drug | bimatoprost ophthalmic solution 0.03% |
Primary outcome
Change From Baseline in Eyelash Length at Month 3
Time frame: Baseline, Month 3
Change from Baseline at Month 3 in eyelash length, measured in millimeters (mm). Data from both eyes were averaged for each subject for analysis. Changes from baseline represented by positive values indicated longer length, and changes from baseline represented by negative values indicated shorter length.
6 secondary outcomes
Change From Baseline in Upper Eyelash Thickness at Month 3
Time frame: Baseline, Month 3
Change From Baseline in Upper Eyelash Darkness (in Intensity Units) at Month 3
Time frame: Baseline, Month 3
Percentage of Subjects With a Clinical Response in Overall Eyelash Prominence on the Global Eyelash Assessment (GEA) at Month 3
Time frame: Month 3
Change From Baseline in Overall Eyelash Satisfaction at Month 3
Time frame: Baseline, Month 3
Change From Baseline in the Confidence, Attractiveness, and Professionalism (CAP) Domain Scores at Month 3
Time frame: Baseline, Month 3
Treatment Satisfaction Questionnaire Score at Month 3
Time frame: Month 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2011.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bimatoprost ophthalmic solution 0.005%, bimatoprost ophthalmic solution 0.015% and bimatoprost ophthalmic solution 0.03% in people with Eyelash Hypotrichosis, run by Allergan at 1 site in United States.
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 2 inclusion and 6 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 9 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 9 Dec 2011). 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?
Change From Baseline in Eyelash Length at Month 3 (time frame: Baseline, Month 3). 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 9 Dec 2011; AzTrials last refreshed its copy on 7 Nov 2026.