Safety, Efficacy, Tolerability and Pharmacokinetics of AGN-223575 Ophthalmic Suspension in Patients With Dry Eye Disease
NCT ID: NCT02435914
Last Updated: 2019-04-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
236 participants
INTERVENTIONAL
2015-06-30
2016-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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AGN-223575 Dose A
1 drop of AGN-223575 Dose A ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose A ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days.
AGN-223575 ophthalmic solution
AGN-223575 ophthalmic solution once or twice daily
AGN-223575 vehicle ophthalmic solution
Vehicle to AGN22375 ophthalmic solution once or twice daily.
AGN-223575 Dose B
1 drop of AGN-223575 Dose B ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose B ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days.
AGN-223575 ophthalmic solution
AGN-223575 ophthalmic solution once or twice daily
AGN-223575 vehicle ophthalmic solution
Vehicle to AGN22375 ophthalmic solution once or twice daily.
AGN-223575 Dose C
1 drop of AGN-223575 Dose C ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose C ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days.
AGN-223575 ophthalmic solution
AGN-223575 ophthalmic solution once or twice daily
AGN-223575 vehicle ophthalmic solution
Vehicle to AGN22375 ophthalmic solution once or twice daily.
AGN-223575 Vehicle
1 drop of Vehicle to AGN-223575 ophthalmic solution administered in each eye twice daily for 14 day followed by 1 drop of vehicle to AGN-223575 ophthalmic solution in each eye once daily for 7 days.
AGN-223575 vehicle ophthalmic solution
Vehicle to AGN22375 ophthalmic solution once or twice daily.
Interventions
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AGN-223575 ophthalmic solution
AGN-223575 ophthalmic solution once or twice daily
AGN-223575 vehicle ophthalmic solution
Vehicle to AGN22375 ophthalmic solution once or twice daily.
Eligibility Criteria
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Inclusion Criteria
* Has used RESTASIS and/or artificial tears in both eyes twice a day for at least 60 days.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Allergan
Locations
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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
Houston Eye Associates
Houston, Texas, United States
Whitsett Vision Group
Houston, Texas, United States
Medical Center Opth. Assoc.
San Antonio, Texas, United States
Countries
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Other Identifiers
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223575-002
Identifier Type: -
Identifier Source: org_study_id
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