EyelashesPhase 3NCT00693420
Safety and Efficacy of Bimatoprost Solution in Increasing Overall Eyelash Prominence
A Phase 3 study testing Bimatoprost 0.03% sterile solution in people with Eyelashes, run by Allergan at 2 sites in 2 countries.
Trial summary
This study evaluates the safety and effectiveness of topical bimatoprost solution for enhancing eyelash prominence. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Eyelashes
- What is being tested?
- Bimatoprost 0.03% sterile solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 278 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2007to Dec 2007
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Dissatisfaction with eyelash prominence,
- Eyelash prominence assessment of minimal or moderate,
- Ability to provide written informed consent
Who cannot join
- Subjects without visible lashes,
- Asymmetrical (uneven lashes or longer on one side than the other) eyelashes,
- Any eye disease or abnormality,
- Eye surgery,
- Permanent eyeliner,
- Eyelash implants,
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- Eyelash extension application,
- Any use of eyelash growth products within 6 months of study entry,
- Treatments that may effect hair growth,
- Subjects requiring eye drop medications for glaucoma,
- Subjects having a situation or condition, which the study doctor feels might put you at risk, may make the study results confusing, or may interfere with the study.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
This study evaluates the safety and effectiveness of topical bimatoprost solution for enhancing eyelash prominence.
- Conditions
- Eyelashes
- Being tested
- Bimatoprost 0.03% sterile solution, vehicle sterile solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bimatoprost 0.03% sterile solutionDrug
Also called LUMIGAN®
Apply one drop of study medication using single-use per eye applicator to upper eyelid margin once daily.
vehicle sterile solutionDrug
Apply one drop of study medication using single-use per eye applicator to upper eyelid margin once daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Bimatoprost 0.03% solution Receives: Drug: Bimatoprost 0.03% sterile solution |
| 2 | Placebo comparator | Vehicle solution Receives: Drug: vehicle sterile solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 16
The GEA scale is an investigator-graded 4-point ordinal scale of overall eyelash prominence (1 [minimal], 2 [moderate], 3 [marked], 4 [very marked])
Measured: Baseline to Week 16
Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 20 (Post-treatment)
The GEA scale is an investigator-graded 4-point ordinal scale of overall eyelash prominence (1 [minimal], 2 [moderate], 3 [marked], 4 [very marked])
Measured: Baseline to Week 20
Secondary outcomes (6)
Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16
Upper eyelash length technologically measured in millimeters
Measured: Baseline to Week 16
Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)
Upper eyelash length technologically measured in millimeters
Measured: Baseline to Week 20
Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16
Progressive thickness technologically measured within preset areas of lashes, expressed in pixels as percentage of the area of interest (AOI). 1 pixel is approximately equal to 0.0273 to 0.0274 mm.
Measured: Baseline to Week 16
Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)
Progressive thickness technologically measured within preset areas of lashes, expressed in pixels as percentage of the area of interest (AOI). 1 pixel is approximately equal to 0.0273 to 0.0274 mm.
Measured: Baseline to Week 20
Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16
Darkness was technologically measured in intensity units ranging from 0 (black) - 255 (white)
Measured: Baseline to Week 16
Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)
Darkness was technologically measured in intensity units ranging from 0 (black) - 255 (white)
Measured: Baseline to Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2008 (estimated)
- Study startApr 2007
- Primary completionOct 2007
- Study completionDec 2007
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EyelashesStudies 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
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00693420
- Sponsor's protocol ID
- 192024-032
- Status last verified
- Sep 2013
- First submitted
- 5 Jun 2008
- Last updated
- 30 Oct 2013
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Fagien S, Walt JG, Carruthers J, Cox SE, Wirta D, Weng E, Beddingfield FC 3rd. Patient-reported outcomes of bimatoprost for eyelash growth: results from a randomized, double-masked, vehicle-controlled, parallel-group study. Aesthet Surg J. 2013 Aug 1;33(6):789-98. doi: 10.1177/1090820X13495887. Epub 2013 Jul 19.
PubMed 23873891
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Bimatoprost Solution in Increasing Overall Eyelash Prominence
- ClinicalTrials.gov ID
- NCT00693420
- Acronym / sponsor ID
- 192024-032
- Conditions
- Eyelashes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 9 Jun 2008 (estimated)
- Results
- Posted 12 May 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the safety and effectiveness of topical bimatoprost solution for enhancing eyelash prominence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Bimatoprost 0.03% sterile solutionBimatoprost 0.03% solution |
| 2 | Placebo comparator | Drug: vehicle sterile solutionVehicle solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Dissatisfaction with eyelash prominence,
- Eyelash prominence assessment of minimal or moderate,
- Ability to provide written informed consent
Key exclusion criteria (11 listed)
- Subjects without visible lashes,
- Asymmetrical (uneven lashes or longer on one side than the other) eyelashes,
- Any eye disease or abnormality,
- Eye surgery,
- Permanent eyeliner,
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 0.03% sterile solutionAlso: LUMIGAN®Apply one drop of study medication using single-use per eye applicator to upper eyelid margin once daily. | Drug | 1 |
| vehicle sterile solutionApply one drop of study medication using single-use per eye applicator to upper eyelid margin once daily | Drug | 2 |
Primary outcome
Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 16
Time frame: Baseline to Week 16
The GEA scale is an investigator-graded 4-point ordinal scale of overall eyelash prominence (1 [minimal], 2 [moderate], 3 [marked], 4 [very marked])
Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 20 (Post-treatment)
Time frame: Baseline to Week 20
The GEA scale is an investigator-graded 4-point ordinal scale of overall eyelash prominence (1 [minimal], 2 [moderate], 3 [marked], 4 [very marked])
6 secondary outcomes
Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16
Time frame: Baseline to Week 16
Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)
Time frame: Baseline to Week 20
Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16
Time frame: Baseline to Week 16
Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)
Time frame: Baseline to Week 20
Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16
Time frame: Baseline to Week 16
Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)
Time frame: Baseline to Week 20
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23873891Fagien S, Walt JG, Carruthers J, Cox SE, Wirta D, Weng E, Beddingfield FC 3rd. Patient-reported outcomes of bimatoprost for eyelash growth: results from a randomized, double-masked, vehicle-controlled, parallel-group study. Aesthet Surg J. 2013 Aug 1;33(6):789-98. doi: 10.1177/1090820X13495887. Epub 2013 Jul 19.
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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
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bimatoprost 0.03% sterile solution in people with Eyelashes, run by Allergan at 2 sites in 2 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 3 inclusion and 11 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 30 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. 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 12 May 2009). 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 Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 16 (time frame: Baseline to Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00693420, which also lists 1 linked publication.
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 30 Oct 2013.