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Bimatoprost 0.03% sterile

Phase 3

Eyelashes | Small molecule | Other |AbbVie Inc.|Last Updated: Oct 30, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment278

FDA Designations

No designations recorded

Clinical trial landscape

Bimatoprost 0.03% sterile · 1 trial · 1 indication

Phase 3 1
NCT00693420Safety and Efficacy of Bimatoprost Solution in Increasing Overall Eyelash ProminenceEyelashes
COMPLETED278 Analytics
PHASE3COMPLETED
Safety and Efficacy of Bimatoprost Solution in Increasing Overall Eyelash Prominence
Eyelashes
NCT00693420278
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Study Endpoints

Primary Endpoints

Percentage of Participants Experiencing at Least a 1-grade Increase on the Global Eyelash Assessment (GEA) Scale From Baseline to Week 16
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)
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 \[very marked\])

Secondary Endpoints

Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16
Baseline to Week 16
Upper Eyelash Length as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 20 (Post-treatment)
Baseline to Week 20
Upper Eyelash Thickness as Measured by Digital Image Analysis in Terms of Change From Baseline to Week 16
Baseline to Week 16
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALBimatoprost 0.03% solution
2PLACEBO_COMPARATORVehicle solution

Interventions

NameTypeDescription
Bimatoprost 0.03% sterile solutionDRUGApply one drop of study medication using single-use per eye applicator to upper eyelid margin once daily.
vehicle sterile solutionDRUGApply one drop of study medication using single-use per eye applicator to upper eyelid margin once daily
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Dissatisfaction with eyelash prominence, * Eyelash prominence assessment of minimal or moderate, * Ability to provide written informed consent Exclusion Criteria: * Subjects without visible lashes, * Asymmetrical (uneven lashes or longer on one side than the other) eyelashes...

Countries:United StatesCanada
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Frequently asked questions about Bimatoprost 0.03% sterile

What is Bimatoprost 0.03% sterile used for?

Bimatoprost 0.03% sterile is used to increase overall eyelash prominence. It is being developed by AbbVie Inc. (ABBV) as a small molecule treatment for eyelashes. The drug is currently in Phase 3 clinical development and remains investigational, meaning it is not yet approved for this use.

Who makes Bimatoprost 0.03% sterile?

Bimatoprost 0.03% sterile is developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The company is conducting clinical trials to evaluate the safety and efficacy of this small molecule for enhancing eyelash prominence.

What phase is Bimatoprost 0.03% sterile in?

Bimatoprost 0.03% sterile is in Phase 3 clinical development. A Phase 3 trial has been completed, and the drug is still investigational for its intended use in increasing eyelash prominence. It has not been approved by regulatory authorities for this indication.

What clinical trials is Bimatoprost 0.03% sterile in?

Bimatoprost 0.03% sterile has one completed Phase 3 clinical trial, identified as NCT00693420, titled "Safety and Efficacy of Bimatoprost Solution in Increasing Overall Eyelash Prominence." The randomized, double-blind, placebo-controlled study enrolled 278 participants in the United States and Canada.

How does Bimatoprost 0.03% sterile work?

Bimatoprost 0.03% sterile is a small molecule that works by targeting the eyelash follicle to promote growth and increase prominence. The exact molecular target is not specified, but the drug is designed to enhance eyelash appearance through its pharmacological action on the hair growth cycle.