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

Allergan163 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

163

Conditions

Ocular Hypertension Primary Open-Angle Glaucoma

Interventions

AGN-210961 Formulation 1DRUG

AGN-210961 Formulation 1 in one eye once daily for 7 days.

AGN-210961 Formulation 2DRUG

AGN-210961 Formulation 2 in one eye once daily for 7 days.

AGN-210961 Formulation 3DRUG

AGN-210961 Formulation 3 in one eye once daily for 7 days.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Newport Beach, California, United States

Outcomes

Primary Outcomes

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

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.

Time frame: Baseline, Day 7

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

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.

Time frame: Baseline, Day 29

Data from ClinicalTrials.gov

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