Clinical trial NCT02435914: Safety, Efficacy, Tolerability and Pharmacokinetics of AGN-223575 Ophthalmic Suspension in Patients With Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Syndromes
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2015-05-06
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change From Baseline in Conjunctival Redness Score in the Study Eye Using a 5-Point Scale
timeFrame: Baseline, Day 14
Secondary outcomes:
measure: Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score Using a 5-Point Scale
timeFrame: Baseline, Day 14
measure: Change From Baseline in Corneal Staining Score of the Study Eye Using a 6-Point Scale
timeFrame: Baseline, Day 14
measure: Percentage of Participants With Complete Redness Response (Yes/No) in the Study Eye
timeFrame: Day 14
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Center for Clinical Trials
state: Arizona
city: Glendale
country: United States
facility: Specialty Eye Ctr. Med. Group
state: California
city: Newport Beach
country: United States
facility: The Eye Research Foundation
state: California
city: Santa Ana
country: United States
facility: WCCT Global
state: California
city: Colorado Springs
country: United States
facility: Eye Associates of Colorado Springs
state: Colorado
city: Lecanto
country: United States
facility: West Coast Eye Institute
state: Florida
city: Morrow
country: United States
facility: Eye Care Centers Management, Inc.
state: Georgia
city: Roswell
country: United States
facility: Coastal Research Assoc. LLC
state: Georgia
city: Hoffman Estates
country: United States
facility: Chicago Cornea Consultants
state: Illinois
city: Overland Park
country: United States
facility: Durrie Vision
state: Kansas
city: Lexington
country: United States
facility: Kentucky Center for Vision
state: Kentucky
city: Boston
country: United States
facility: Tufts Medical Center/ Tufts University School of Medicine
state: Massachusetts
city: Kansas City
country: United States
facility: Moyes Eye Center
state: Missouri
city: Saint Louis
country: United States
facility: Ophthalmology Associates
state: Missouri
city: Washington
country: United States
facility: Comprehensive Eye Care Ltd.
state: Missouri
city: New York
country: United States
facility: Raymond Fong MD, PC
state: New York
city: Wantagh
country: United States
facility: South Shore Eye Care LLP
state: New York
city: Charlotte
country: United States
facility: SE Clinical Research Associates, LLC/ Charolette Eye Ear Nose
state: North Carolina
city: High Point
country: United States
facility: Cornerstone Eye Care
state: North Carolina
city: Cincinnati
country: United States
facility: Eye Care Associates of Greater Cincinnati
state: Ohio
city: Portland
country: United States
facility: Mark A. Terry, MD PC/ Devers Eye Institute
state: Oregon
city: Charleston
country: United States
facility: Bluestein Custom Vision
state: South Carolina
city: Florence
country: United States
facility: Carolinas Centers for Sight, PC
state: South Carolina
city: Rapid City
country: United States
facility: Black Hills Regional Eye Institute
state: South Dakota
city: Austin
country: United States
facility: Keystone Clinical Research
state: Texas
city: Houston
country: United States
facility: Houston Eye Associates
state: Texas
city: Houston
country: United States
facility: Whitsett Vision Group
state: Texas
city: San Antonio
country: United States
facility: Medical Center Opth. Assoc.
state: Texas
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References: