NCT01110499

Completed

Phase 2

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

Allergan0 sites163 target enrollmentJune 2010

ConditionsOcular Hypertension Primary Open-Angle Glaucoma

InterventionsAGN-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 bimatoprost ophthalmic solution 0.03%

DrugsAGN-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 bimatoprost ophthalmic solution 0.03%

Overview

Phase: Phase 2
Intervention: AGN-210961 Formulation 1
Conditions: Ocular Hypertension
Sponsor: Allergan
Enrollment: 163
Primary Endpoint: Part 1: Change From Baseline in Intraocular Pressure (IOP)
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

June 2010

End Date

June 2011

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Allergan

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Part 1, AGN-210961 Formulation 1

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

Intervention: AGN-210961 Formulation 1

Part 1, AGN-210961 Formulation 2

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

Intervention: AGN-210961 Formulation 2

Part 1, AGN-210961 Formulation 3

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

Intervention: AGN-210961 Formulation 3

Part 1, AGN-210961 Formulation 4

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

Intervention: AGN-210961 Formulation 4

Part 1, AGN-210961 Formulation 5

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

Intervention: AGN-210961 Formulation 5

Part 1, AGN-210961 Formulation 6

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

Intervention: AGN-210961 Formulation 6

Part 2, AGN-210961 Formulation 7

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

Intervention: AGN-210961 Formulation 7

Part 2, bimatoprost ophthalmic solution 0.03%

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

Intervention: bimatoprost ophthalmic solution 0.03%

Outcomes

Primary Outcomes

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

Time Frame: 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)

Time Frame: 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.