Safety, Efficacy, Tolerability and Pharmacokinetics of AGN-223575 Ophthalmic Suspension in Patients With Dry Eye Disease

Completed · Phase 2

Conditions studied: Dry Eye Syndromes

In brief

This study will evaluate the safety, efficacy, tolerability, and systemic pharmacokinetics of 3 different doses of topical ophthalmic AGN-223575 suspension compared to AGN-223575 vehicle in patients with dry eye disease.

Key facts

Study ID

NCT02435914

Run by

Allergan

People needed

236

Starts

2015-06-01

Expected to finish

2016-01-01

Last updated by the study team

2019-04-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signs and symptoms of dry eye disease
• Has used RESTASIS and/or artificial tears in both eyes twice a day for at least 60 days.

You may not qualify if…

• History of glaucoma, or ocular hypertension
• Diagnosis of ocular infection
• Use of contact lenses in the past 14 days or expected use during the study
• Use of any topical ophthalmic medications in the past 30 days
• Use of corticosteroids in the past 30 days.

Where it is running

• Arizona Center for Clinical Trials — Phoenix, Arizona, United States
• Specialty Eye Ctr. Med. Group — Glendale, California, United States
• The Eye Research Foundation — Newport Beach, California, United States
• WCCT Global — Santa Ana, California, United States
• Eye Associates of Colorado Springs — Colorado Springs, Colorado, United States
• West Coast Eye Institute — Lecanto, Florida, United States
• Eye Care Centers Management, Inc. — Morrow, Georgia, United States
• Coastal Research Assoc. LLC — Roswell, Georgia, United States
• Chicago Cornea Consultants — Hoffman Estates, Illinois, United States
• Durrie Vision — Overland Park, Kansas, United States
• Kentucky Center for Vision — Lexington, Kentucky, United States
• Tufts Medical Center/ Tufts University School of Medicine — Boston, Massachusetts, United States
• Moyes Eye Center — Kansas City, Missouri, United States
• Ophthalmology Associates — St Louis, Missouri, United States
• Comprehensive Eye Care Ltd. — Washington, Missouri, United States
• Raymond Fong MD, PC — New York, New York, United States
• South Shore Eye Care LLP — Wantagh, New York, United States
• SE Clinical Research Associates, LLC/ Charolette Eye Ear Nose — Charlotte, North Carolina, United States
• Cornerstone Eye Care — High Point, North Carolina, United States
• Eye Care Associates of Greater Cincinnati — Cincinnati, Ohio, United States
• Mark A. Terry, MD PC/ Devers Eye Institute — Portland, Oregon, United States
• Bluestein Custom Vision — Charleston, South Carolina, United States
• Carolinas Centers for Sight, PC — Florence, South Carolina, United States
• Black Hills Regional Eye Institute — Rapid City, South Dakota, United States
• Keystone Clinical Research — Austin, Texas, United States

Full record on ClinicalTrials.gov

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