Safety and Pharmacodynamics Study of AGN-207281 Ophthalmic Solutions Compared With Timolol Ophthalmic Solution or Placebo in Patients With Ocular Hypertension or Primary Open-Angle Glaucoma

Allergan50 enrolled

Overview

This is an exploratory study that will evaluate the safety and pharmacodynamics of up to 3 doses of AGN-207281 based on an ongoing review of data during the study period compared with timolol ophthalmic solution or placebo in patients with ocular hypertension or primary open-angle glaucoma.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Glaucoma, Open-Angle Ocular Hypertension

Interventions

AGN-207281 ophthalmic solutions (0.1% and 0.3%); AGN-207281 vehicle ophthalmic solution (placebo)DRUG

One drop of AGN-207281 ophthalmic solutions (0.1% on Days 1-7 and 0.3% on Days 8-14) instilled to both eyes in the morning followed by one drop of AGN-207281 vehicle ophthalmic solution (placebo) instilled to both eyes in the evening for 13 days.

timolol ophthalmic solution 0.5%DRUG

One drop of timolol ophthalmic solution 0.5% instilled to both eyes, in the morning for 14 days, and in the evening for 13 days

AGN-207281 vehicle ophthalmic solution (Placebo)DRUG

One drop of AGN-207281 vehicle ophthalmic solution instilled to both eyes, in the morning for 14 days and in the evening for 13 days.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Ocular hypertension or primary open-angle glaucoma in each eye * Requires IOP-lowering therapy in both eyes * Visual acuity score of 20/100 or better in each eye Exclusion Criteria: * Experienced significant weight change (over 10 pounds) within 60 days * History of alcohol or drug addiction * History of migraines or frequent headaches * Anticipated wearing of contact lenses during the study * Required chronic use of ocular medications during study * Eye surgery within 6 months * Use of systemic beta blockers (eg, atenolol, propranolol) within 2 months * Use of oral, intramuscular, intravenous corticosteroids within 21 days * Use of ophthalmic corticosteroids within 2 months

Locations (1)

Unnamed facility

Newport Beach, California, United States

Outcomes

Primary Outcomes

Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14

Change from baseline in worse eye IOP at day 14. Worse eye IOP refers to the eye with the worse (highest) baseline IOP (a measurement of the fluid pressure inside the eye). A negative number change from baseline indicates a reduction in IOP (improvement).

Time frame: Baseline, Day 14

Secondary Outcomes

Mean Concentration of AGN-207281 in Plasma at Day 7

Mean concentration of AGN-207281 in plasma at day 7. Plasma is the liquid component of the blood in which the blood cells are suspended. On day 7, the plasma sample collected 15 minutes post-morning dose from each patient receiving AGN-207281 was analyzed to determine the average drug concentration levels of AGN-207281.

Time frame: Day 7

Mean Concentration of AGN-207281 in Plasma at Day 14

Mean concentration of AGN-207281 in plasma at day 14. Plasma is the liquid component of the blood in which the blood cells are suspended. On day 14, the plasma sample collected 15 minutes post-morning dose from each patient receiving AGN-207281 was analyzed to determine the average drug concentration levels of AGN-207281.

Time frame: Day 14

Data from ClinicalTrials.gov

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