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bimatoprost 20 µg generation 2

Phase 1

Open-Angle Glaucoma | Small molecule | Ophthalmology |AbbVie Inc.|Last Updated: Mar 30, 2020

Success Probability

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment109

FDA Designations

No designations recorded

Clinical trial landscape

bimatoprost 20 µg generation 2 · 1 trial · 2 indications

Phase 1 1
NCT01157364Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular HypertensionOpen-Angle Glaucoma
COMPLETED109 Analytics
PHASE1COMPLETED
Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular Hypertension
Open-Angle GlaucomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye
Baseline, Month 24

IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.

Secondary Endpoints

Time-Matched Intraocular Pressure (IOP) in the Study Eye
Baseline to Month 6
Mean Diurnal IOP in the Study Eye
Baseline, Month 6
Time to Rescue Treatment or Re-Treatment in the Study Eye
24 Months
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
bimatoprost 20 µg generation 2, bimatoprost 0.03%OTHERSingle dose of bimatoprost ophthalmic 20 µg generation 2 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
bimatoprost 15 µg generation 2, bimatoprost 0.03%OTHERSingle dose of bimatoprost ophthalmic 15 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
bimatoprost 10 µg generation 2, bimatoprost 0.03%OTHERSingle dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
bimatoprost 6 µg generation 2, bimatoprost 0.03%OTHERSingle dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
bimatoprost 15 µg generation 1, bimatoprost 0.03%OTHERSingle dose of bimatoprost ophthalmic 15 µg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
bimatoprost 10 µg generation 1, bimatoprost 0.03%OTHERSingle dose of bimatoprost ophthalmic 10 µg generation 1 administered in the study eye on Day 1. One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.

Interventions

NameTypeDescription
bimatoprost 20 µg generation 2DRUGSingle dose of bimatoprost ophthalmic administered in the study eye on Day 1.
bimatoprost 15 µg generation 2DRUGSingle dose of bimatoprost ophthalmic administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).
bimatoprost 10 µg generation 2DRUGSingle dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).
bimatoprost 6 µg generation 2DRUGSingle dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).
bimatoprost 15 µg generation 1DRUGSingle dose of bimatoprost ophthalmic 15 µg generation 1 administered in the study eye on Day 1.
bimatoprost 10 µg generation 1DRUGSingle dose of bimatoprost ophthalmic 10 µg generation 1 administered in the study eye on Day 1.
bimatoprost 0.03%DRUGOne drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites57

Inclusion Criteria: * Diagnosis of open angle glaucoma or ocular hypertension Exclusion Criteria: * Uncontrolled medical conditions * Anticipated wearing of contact lenses during the study

Countries:United StatesAustraliaBelgiumBrazilCanadaGermanyIsraelPhilippinesSingaporeSpain
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Competitive Landscape -Open-Angle Glaucoma 9 trials

Frequently asked questions about bimatoprost 20 µg generation 2

What is bimatoprost 20 µg generation 2 used for?

Bimatoprost 20 µg generation 2 is an investigational small molecule being developed for the treatment of open-angle glaucoma. It is administered as an ophthalmic formulation. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes bimatoprost 20 µg generation 2?

Bimatoprost 20 µg generation 2 is being developed by AbbVie Inc. (NYSE: ABBV). The company is conducting clinical trials to evaluate the safety and efficacy of this ophthalmic formulation in patients with open-angle glaucoma and ocular hypertension.

What phase is bimatoprost 20 µg generation 2 in?

Bimatoprost 20 µg generation 2 is in Phase 1 clinical development. One Phase 1 trial has been completed, involving 109 participants. The drug is investigational and has not yet received FDA approval.

What clinical trials is bimatoprost 20 µg generation 2 in?

Bimatoprost 20 µg generation 2 has one completed clinical trial, NCT01157364, titled "Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular Hypertension." This Phase 1 study enrolled 109 participants across multiple countries.

Is bimatoprost 20 µg generation 2 the same as bimatoprost?

Bimatoprost 20 µg generation 2 is a specific formulation of bimatoprost, a prostaglandin analog used to lower intraocular pressure. The "20 µg generation 2" designation refers to a particular ophthalmic formulation being developed by AbbVie for open-angle glaucoma.