HypotrichosisPhase 4NCT01448525
Study Assessing Patient Satisfaction With LATISSE® for Increasing Eyelash Prominence
A Phase 4 study testing bimatoprost ophthalmic solution 0.03% in people with Hypotrichosis, run by Allergan at 1 site in United States.
Trial summary
The purpose of this study is to determine patient satisfaction with LATISSE® treatment for increasing eyelash prominence. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Hypotrichosis
- What is being tested?
- bimatoprost ophthalmic solution 0.03%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Apr 2012
- Phase
- Phase 4
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have inadequate eyelashes
- Never used prescription eyelash growth products
Who cannot join
- No visible eyelashes
- Permanent eyeliner or eyelash implants
- Semi-permanent eyelash tint, dye, or extensions within 3 months
- Over-the-counter eyelash growth products within 6 months
- Any disease, infection or abnormality of the eye or area around the eye
- Eye surgery within 3 months, or the anticipated need for eye surgery during the study
- Unable or unwilling to keep contact lenses out during drug application and for 30 minutes after application
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine patient satisfaction with LATISSE® treatment for increasing eyelash prominence.
- Conditions
- Hypotrichosis
- Being tested
- bimatoprost ophthalmic solution 0.03%, bimatoprost vehicle solution
- Medical subject headings
- Hypotrichosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bimatoprost ophthalmic solution 0.03%Drug
Also called LATISSE®
One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
bimatoprost vehicle solutionDrug
One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| bimatoprost ophthalmic solution 0.03% | Active comparator | One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks. Receives: Drug: bimatoprost ophthalmic solution 0.03% |
| bimatoprost vehicle solution | Placebo comparator | One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks. Receives: Drug: bimatoprost vehicle solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Are Satisfied or Very Satisfied With Their Eyelashes Overall
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: -2=very unsatisfied (worst), -1=unsatisfied, 0=neutral, 1=satisfied or 2=very satisfied (best). The percentage of participants who rated their satisfaction as 1=satisfied or 2=very satisfied at Week 16 is reported.
Measured: Week 16
Secondary outcomes (1)
Percentage of Participants With at Least a 1-Grade Increase in the Global Eyelash Assessment (GEA) Score
The investigator evaluated the patient's overall eyelash prominence using the 4-point GEA scale: 1=minimal (worst), 2=moderate, 3=marked or 4=very marked (best). An at least a 1-grade increase in GEA score indicated improvement.
Measured: Baseline, Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionApr 2012
- Study completionApr 2012
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 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 88 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
- NCT01448525
- Sponsor's protocol ID
- GMA-LTS-11-002
- Status last verified
- Apr 2013
- First submitted
- 6 Oct 2011
- Last updated
- 22 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Assessing Patient Satisfaction With LATISSE® for Increasing Eyelash Prominence
- ClinicalTrials.gov ID
- NCT01448525
- Acronym / sponsor ID
- GMA-LTS-11-002
- Conditions
- Hypotrichosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 7 Oct 2011 (estimated)
- Results
- Posted 22 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine patient satisfaction with LATISSE® treatment for increasing eyelash prominence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bimatoprost ophthalmic solution 0.03% | Active comparator | Drug: bimatoprost ophthalmic solution 0.03%One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks. |
| bimatoprost vehicle solution | Placebo comparator | Drug: bimatoprost vehicle solutionOne drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have inadequate eyelashes
- Never used prescription eyelash growth products
Key exclusion criteria (7 listed)
- No visible eyelashes
- Permanent eyeliner or eyelash implants
- Semi-permanent eyelash tint, dye, or extensions within 3 months
- Over-the-counter eyelash growth products within 6 months
- Any disease, infection or abnormality of the eye or area around the eye
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 0.03%Also: LATISSE®One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks. | Drug | bimatoprost ophthalmic solution 0.03% |
| bimatoprost vehicle solutionOne drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks. | Drug | bimatoprost vehicle solution |
Primary outcome
Percentage of Participants Who Are Satisfied or Very Satisfied With Their Eyelashes Overall
Time frame: Week 16
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: -2=very unsatisfied (worst), -1=unsatisfied, 0=neutral, 1=satisfied or 2=very satisfied (best). The percentage of participants who rated their satisfaction as 1=satisfied or 2=very satisfied at Week 16 is reported.
1 secondary outcome
Percentage of Participants With at Least a 1-Grade Increase in the Global Eyelash Assessment (GEA) Score
Time frame: Baseline, Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 4 study testing bimatoprost ophthalmic solution 0.03% in people with 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 7 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 22 May 2013. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 22 May 2013). 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 Who Are Satisfied or Very Satisfied With Their Eyelashes Overall (time frame: Week 16). 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 22 May 2013.