Safety and Efficacy of AGN-210961 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

Allergan

Status and phase: Completed; Phase 2

Conditions: Primary Open-Angle Glaucoma; Ocular Hypertension

Treatments: Drug: AGN-210961 Formulation 2; Drug: AGN-210961 Formulation 6; Drug: AGN-210961 Formulation 5; Drug: bimatoprost ophthalmic solution 0.03%; Drug: AGN-210961 Formulation 4; Drug: AGN-210961 Formulation 3; Drug: AGN-210961 Formulation 7; Drug: AGN-210961 Formulation 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT01110499

210961-002

Details and patient eligibility

About

This study has 2 parts. Part 1 will evaluate the safety and IOP effects of 6 formulations of AGN-210961 ophthalmic solution in the study eye and bimatoprost ophthalmic solution 0.03% in the fellow eye for 7 consecutive days. Part 2 will evaluate the safety and IOP effects of a formulation (to be selected from part 1) of AGN-210961 in both eyes compared to bimatoprost ophthalmic solution 0.03% for 4 weeks.

Enrollment: 163 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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163 participants in 8 patient groups

Part 1, AGN-210961 Formulation 1

Experimental group

Description:

AGN-210961 Formulation 1 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.

Treatment:

Drug: AGN-210961 Formulation 1

Part 1, AGN-210961 Formulation 2

Experimental group

Description:

AGN-210961 Formulation 2 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.

Treatment:

Drug: AGN-210961 Formulation 2

Part 1, AGN-210961 Formulation 3

Experimental group

Description:

AGN-210961 Formulation 3 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.

Treatment:

Drug: AGN-210961 Formulation 3

Part 1, AGN-210961 Formulation 4

Experimental group

Description:

AGN-210961 Formulation 4 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.

Treatment:

Drug: AGN-210961 Formulation 4

Part 1, AGN-210961 Formulation 5

Experimental group

Description:

AGN-210961 Formulation 5 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.

Treatment:

Drug: AGN-210961 Formulation 5

Part 1, AGN-210961 Formulation 6

Experimental group

Description:

AGN-210961 Formulation 6 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.

Treatment:

Drug: AGN-210961 Formulation 6

Part 2, AGN-210961 Formulation 7

Experimental group

Description:

AGN-210961 Formulation 7 in both eyes once daily for 4 weeks.

Treatment:

Drug: AGN-210961 Formulation 7

Part 2, bimatoprost ophthalmic solution 0.03%

Active Comparator group

Description:

bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks.

Treatment:

Drug: bimatoprost ophthalmic solution 0.03%