Safety and Efficacy of Bimatoprost Ophthalmic Solution in Increasing Eyelash Prominence - Full Text View

Purpose

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

Condition	Intervention	Phase
Eyelash Hypotrichosis	Drug: bimatoprost ophthalmic solution 0.005% Drug: bimatoprost ophthalmic solution 0.015% Drug: bimatoprost ophthalmic solution 0.03%	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Hair Loss

Drug Information available for: Bimatoprost

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

Change From Baseline in Eyelash Length at Month 3 [ Time Frame: Baseline, Month 3 ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Change From Baseline in Upper Eyelash Thickness at Month 3 [ Time Frame: Baseline, Month 3 ] [ Designated as safety issue: No ]
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.
Change From Baseline in Upper Eyelash Darkness (in Intensity Units) at Month 3 [ Time Frame: Baseline, Month 3 ] [ Designated as safety issue: No ]
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.
Percentage of Subjects With a Clinical Response in Overall Eyelash Prominence on the Global Eyelash Assessment (GEA) at Month 3 [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
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.
Change From Baseline in Overall Eyelash Satisfaction at Month 3 [ Time Frame: Baseline, Month 3 ] [ Designated as safety issue: No ]
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.
Change From Baseline in the Confidence, Attractiveness, and Professionalism (CAP) Domain Scores at Month 3 [ Time Frame: Baseline, Month 3 ] [ Designated as safety issue: No ]
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.
Treatment Satisfaction Questionnaire Score at Month 3 [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
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).

Enrollment:	104
Study Start Date:	March 2010
Study Completion Date:	July 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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% 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 Name: LATISSE®

Eligibility

Ages Eligible for Study:	30 Years to 55 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01064882

Locations

United States, California

San Diego, California, United States

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

No publications provided

Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT01064882 History of Changes
Other Study ID Numbers:	192024-051
Study First Received:	February 5, 2010
Results First Received:	August 18, 2011
Last Updated:	November 7, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Hypotrichosis
Hair Diseases
Skin Diseases
Bimatoprost
Cloprostenol
Antihypertensive Agents
Cardiovascular Agents

Therapeutic Uses
Pharmacologic Actions
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013