Safety and Efficacy of Bimatoprost Ophthalmic Solution in Increasing Eyelash Prominence

November 7, 2011 updated by: Allergan
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
104

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: bimatoprost ophthalmic solution 0.005%
bimatoprost ophthalmic sterile solution 0.005%
Drug: 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)
Experimental: bimatoprost ophthalmic solution 0.015%
bimatoprost ophthalmic sterile solution 0.015%
Drug: 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)
Active Comparator: bimatoprost ophthalmic solution 0.03%
Drug: bimatoprost ophthalmic solution 0.03%
One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margins (where the eyelashes meet the skin)
Other Names:
  • LATISSE®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, Month 3

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Upper Eyelash Thickness at Month 3
Time Frame: Baseline, 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.
Baseline, Month 3
Change From Baseline in Upper Eyelash Darkness (in Intensity Units) at Month 3
Time Frame: Baseline, 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.
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
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.
Month 3
Change From Baseline in Overall Eyelash Satisfaction at Month 3
Time Frame: Baseline, 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.
Baseline, Month 3
Change From Baseline in the Confidence, Attractiveness, and Professionalism (CAP) Domain Scores at Month 3
Time Frame: Baseline, 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.
Baseline, Month 3
Treatment Satisfaction Questionnaire Score at Month 3
Time Frame: 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).
Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 9, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 192024-051

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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