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

Phase 2

Completed

• Conditions: Ocular Hypertension; Primary Open-Angle Glaucoma
• Interventions: Drug: AGN-210961 Formulation 2; Drug: AGN-210961 Formulation 1; Drug: AGN-210961 Formulation 4; Drug: AGN-210961 Formulation 7; Drug: bimatoprost ophthalmic solution 0.03%; Drug: AGN-210961 Formulation 3; Drug: AGN-210961 Formulation 5; Drug: AGN-210961 Formulation 6

• Registration Number: NCT01110499
• Lead Sponsor: Allergan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-23
• Study First Submitted QC: 2010-04-23
• Study First Posted: 2010-04-26
• Study Start: 2010-06
• Primary Completion: 2011-05
• Study Completion: 2011-06
• Disposition First Submitted: 2012-05-25
• Disposition First Submitted QC: 2012-05-25
• Disposition First Posted: 2012-06-01
• Results First Submitted: 2013-05-31
• Status Verified: 2014-07
• Results First Submitted QC: 2014-07-10
• Last Update Submitted: 2014-07-10
• Results First Posted: 2014-08-05
• Last Update Posted: 2014-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 163

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part 1, AGN-210961 Formulation 2	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.
Part 1, AGN-210961 Formulation 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.
Part 1, AGN-210961 Formulation 4	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.
Part 2, AGN-210961 Formulation 7	AGN-210961 Formulation 7	AGN-210961 Formulation 7 in both eyes once daily for 4 weeks.
Part 2, bimatoprost ophthalmic solution 0.03%	bimatoprost ophthalmic solution 0.03%	bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks.
Part 1, AGN-210961 Formulation 3	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.
Part 1, AGN-210961 Formulation 5	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.
Part 1, AGN-210961 Formulation 6	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.

Primary Outcome Measures

Name	Time	Method
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.