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AGN-210961

Phase 2

Ocular Hypertension | Small molecule | Ophthalmology |AbbVie Inc.|Last Updated: Aug 5, 2014

Target and mechanism

ModalitySmall molecule

Also known as AGN-210961 Formulation 1, AGN-210961 Formulation 2, AGN-210961 Formulation 3, AGN-210961 Formulation 4, AGN-210961 Formulation 5, AGN-210961 Formulation 6, AGN-210961 Formulation 7

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment163

FDA Designations

No designations recorded

Clinical trial landscape

AGN-210961 · 1 trial · 2 indications

Phase 2 1
NCT01110499Safety and Efficacy of AGN-210961 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular HypertensionOcular Hypertension
COMPLETED163 Analytics
PHASE2COMPLETED
Safety and Efficacy of AGN-210961 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
Ocular HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

Part 1: Change From Baseline in Intraocular Pressure (IOP)
Baseline, Day 7

IOP is a measurement of the fluid pressure inside the eye. Data are recorded at Hours 0, 2, 4, 6, 8, and 12. A negative number change from Baseline indicated a reduction in IOP (improvement). Data for bimatoprost-treated eyes are combined across groups.

Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP)
Baseline, Day 29

IOP is a measurement of the fluid pressure inside the eye. Average IOP is the average of the 2 eyes for each patient at each time point. A negative number change from Baseline indicates a reduction in IOP (improvement). Data are recorded at Hours 0, 2, 4, 6, 8, and 12.

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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1, AGN-210961 Formulation 1EXPERIMENTALAGN-210961 Formulation 1 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
Part 1, AGN-210961 Formulation 2EXPERIMENTALAGN-210961 Formulation 2 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
Part 1, AGN-210961 Formulation 3EXPERIMENTALAGN-210961 Formulation 3 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
Part 1, AGN-210961 Formulation 4EXPERIMENTALAGN-210961 Formulation 4 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
Part 1, AGN-210961 Formulation 5EXPERIMENTALAGN-210961 Formulation 5 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
Part 1, AGN-210961 Formulation 6EXPERIMENTALAGN-210961 Formulation 6 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
Part 2, AGN-210961 Formulation 7EXPERIMENTALAGN-210961 Formulation 7 in both eyes once daily for 4 weeks.
Part 2, bimatoprost ophthalmic solution 0.03%ACTIVE_COMPARATORbimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks.

Interventions

NameTypeDescription
AGN-210961 Formulation 1DRUGAGN-210961 Formulation 1 in one eye once daily for 7 days.
AGN-210961 Formulation 2DRUGAGN-210961 Formulation 2 in one eye once daily for 7 days.
AGN-210961 Formulation 3DRUGAGN-210961 Formulation 3 in one eye once daily for 7 days.
AGN-210961 Formulation 4DRUGAGN-210961 Formulation 4 in one eye once daily for 7 days.
AGN-210961 Formulation 5DRUGAGN-210961 Formulation 5 in one eye once daily for 7 days.
AGN-210961 Formulation 6DRUGAGN-210961 Formulation 6 in one eye once daily for 7 days.
AGN-210961 Formulation 7DRUGAGN-210961 Formulation 7 in both eyes once daily for 4 weeks.
bimatoprost ophthalmic solution 0.03%DRUGbimatoprost ophthalmic solution 0.03% (LUMIGAN®) in both eyes once daily for 4 weeks.
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Eligibility Criteria

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

Inclusion Criteria: \- Ocular hypertension or primary open-angle glaucoma in each eye Exclusion Criteria: * Any active ocular disease * Anticipated wearing of contact lenses during study * Anticipated use of artificial tears during study * Contraindication to pupil dilatation

Countries:United States
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Competitive Landscape -Ocular Hypertension 7 trials