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

Sponsor:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00693420

Purpose

This study evaluates the safety and effectiveness of topical bimatoprost solution for enhancing eyelash prominence.

Condition	Intervention	Phase
Eyelashes	Drug: Bimatoprost 0.03% sterile solution Drug: vehicle sterile solution	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:

Drug Information available for: Bimatoprost

Further study details as provided by Allergan:

Primary Outcome Measures:

Percentage of Participants Experiencing at Least a 1-Grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
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: Week 20 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-Treatment) [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-Treatment) [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
Upper Eyelash Darkness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-Treatment) [ Time Frame: Week 20 ] [ Designated as safety issue: No ]

Enrollment:	278
Study Start Date:	April 2007
Study Completion Date:	December 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Bimatoprost 0.03% solution	Drug: Bimatoprost 0.03% sterile solution Apply one drop of study medication using single-use per eye applicator to upper eyelid margin once daily.
2: Placebo Comparator Vehicle solution	Drug: vehicle sterile solution Apply one drop of study medication using single-use per eye applicator to upper eyelid margin once daily

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

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,
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00693420

Locations

United States, California

San Diego, California, United States
Canada, British Columbia

Vancouver, British Columbia, Canada

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

No publications provided

Responsible Party:	Allergan, Inc. ( Therapeutic Area Head )
Study ID Numbers:	192024-032
Study First Received:	June 5, 2008
Results First Received:	January 14, 2009
Last Updated:	March 26, 2009
ClinicalTrials.gov Identifier:	NCT00693420 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Bimatoprost
Therapeutic Uses
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 05, 2009