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

Phase 1

Completed

• Conditions: Ocular Hypertension; Glaucoma, Open-Angle
• Interventions: Drug: AGN-207281 vehicle ophthalmic solution (Placebo); Drug: AGN-207281 ophthalmic solutions (0.1% and 0.3%); AGN-207281 vehicle ophthalmic solution (placebo); Drug: timolol ophthalmic solution 0.5%

• Registration Number: NCT01215786
• Lead Sponsor: Allergan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-05
• Study First Submitted QC: 2010-10-06
• Study First Posted: 2010-10-07
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Results First Submitted: 2011-12-08
• Results First Submitted QC: 2011-12-08
• Results First Posted: 2012-01-16
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-22
• Last Update Posted: 2015-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	AGN-207281 vehicle ophthalmic solution (Placebo)	AGN-207281 vehicle ophthalmic solution (Placebo)
AGN-207281 ophthalmic solution	AGN-207281 ophthalmic solutions (0.1% and 0.3%); AGN-207281 vehicle ophthalmic solution (placebo)	AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14
Timolol ophthalmic solution 0.5%	timolol ophthalmic solution 0.5%	timolol ophthalmic solution 0.5%

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14	Baseline, 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).

Secondary Outcome Measures

Name	Time	Method
Mean Concentration of AGN-207281 in Plasma at Day 7	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.
Mean Concentration of AGN-207281 in Plasma at Day 14	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.