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Bimatoprost 0.03% Formulation B

Phase 3

Glaucoma | Small molecule | Ophthalmology |AbbVie Inc.|Last Updated: Apr 17, 2019

Target and mechanism

ModalitySmall molecule

Also known as Bimatoprost 0.03% Formulation B Ophthalmic Solution

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment597

FDA Designations

No designations recorded

Clinical trial landscape

Bimatoprost 0.03% Formulation B · 1 trial · 2 indications

Phase 3 1
NCT01099774Safety and Efficacy of Different Formulations of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular HypertensionGlaucoma
COMPLETED597 Analytics
PHASE3COMPLETED
Safety and Efficacy of Different Formulations of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
GlaucomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12
Baseline, Week 12

Change from baseline in worse eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements in the worse eye were evaluated at hours 0, 2, and 8. A negative number change from baseline indicated a reduction in IOP, and a positive number change from baseline indicated an increase in IOP.

Average Eye IOP at Week 12
Baseline, Week 12

Average Eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported. Baseline data are included for reference only.

Average Eye IOP at Week 6
Week 6

Average Eye IOP at Week 6 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported.

Average Eye IOP at Week 2
Week 2

Average Eye IOP at Week 2 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported.

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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Bimatoprost 0.03% Formulation B Ophthalmic SolutionEXPERIMENTALBimatoprost 0.03% Formulation B Ophthalmic Solution
Bimatoprost 0.03% Ophthalmic SolutionACTIVE_COMPARATORBimatoprost 0.03% Ophthalmic Solution

Interventions

NameTypeDescription
Bimatoprost 0.03% Formulation B Ophthalmic SolutionDRUGOne drop administered in each eye, every evening, for 12 weeks
Bimatoprost 0.03% Ophthalmic SolutionDRUGOne drop administered in each eye, every evening, for 12 weeks
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patient has ocular hypertension or glaucoma in both eyes * Requires IOP-lowering therapy in each eye Exclusion Criteria: * Active or recurrent eye disease that would interfere with interpretation of study data in either eye * History of any eye surgery or laser in either eye...

Countries:United States
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