Safety, Efficacy, Tolerability and Pharmacokinetics of AGN-223575 Ophthalmic Suspension in Patients With Dry Eye Disease
1 other identifier
interventional
236
1 country
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2015
Shorter than P25 for phase_2
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 1, 2015
CompletedFirst Posted
Study publicly available on registry
May 6, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedResults Posted
Study results publicly available
April 5, 2019
CompletedApril 5, 2019
March 1, 2019
7 months
May 1, 2015
March 15, 2019
March 15, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Conjunctival Redness Score in the Study Eye Using a 5-Point Scale
Nasal and temporal bulbar conjunctival hyperemia were graded separately in each eye by the investigator under slit-lamp magnification by assigning a score of 0 to 4 for each quadrant based on comparison to the Allergan Dry Eye Redness Scale with photographic reference where: 0=Normal, vessels of bulbar conjunctiva are easily observed; 1=Trace redness; 2=Mild redness; 3=Moderate redness; 4=Severe redness, and each score is associated with a reference photo. For each eye, the study quadrant was determined by the greater (more severe) of the baseline redness scores for nasal and temporal bulbar conjunctival hyperemia as assessed using the Allergan Dry Eye Redness Scale. If the temporal score was greater than the nasal score, then the temporal quadrant was the study quadrant for the eye and was used to assess primary efficacy; otherwise the nasal quadrant was the study quadrant. A negative change from baseline (less redness) indicates improvement.
Baseline, Day 14
Secondary Outcomes (3)
Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score Using a 5-Point Scale
Baseline, Day 14
Change From Baseline in Corneal Staining Score of the Study Eye Using a 6-Point Scale
Baseline, Day 14
Percentage of Participants With Complete Redness Response (Yes/No) in the Study Eye
Day 14
Study Arms (4)
AGN-223575 Dose A
EXPERIMENTAL1 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 Dose B
EXPERIMENTAL1 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 Dose C
EXPERIMENTAL1 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 Vehicle
PLACEBO COMPARATOR1 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.
Interventions
AGN-223575 ophthalmic solution once or twice daily
Vehicle to AGN22375 ophthalmic solution once or twice daily.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (28)
Arizona Center for Clinical Trials
Phoenix, Arizona, 85003, United States
Specialty Eye Ctr. Med. Group
Glendale, California, 91203, United States
The Eye Research Foundation
Newport Beach, California, 92663, United States
WCCT Global
Santa Ana, California, 92705, United States
Eye Associates of Colorado Springs
Colorado Springs, Colorado, 80909, United States
West Coast Eye Institute
Lecanto, Florida, 34491, United States
Eye Care Centers Management, Inc.
Morrow, Georgia, 30260, United States
Coastal Research Assoc. LLC
Roswell, Georgia, 30076, United States
Chicago Cornea Consultants
Hoffman Estates, Illinois, 60169, United States
Durrie Vision
Overland Park, Kansas, 66211, United States
Kentucky Center for Vision
Lexington, Kentucky, 40509, United States
Tufts Medical Center/ Tufts University School of Medicine
Boston, Massachusetts, 02111, United States
Moyes Eye Center
Kansas City, Missouri, 64154, United States
Ophthalmology Associates
St Louis, Missouri, 63131, United States
Comprehensive Eye Care Ltd.
Washington, Missouri, 63090, United States
Raymond Fong MD, PC
New York, New York, 10013, United States
South Shore Eye Care LLP
Wantagh, New York, 11793, United States
SE Clinical Research Associates, LLC/ Charolette Eye Ear Nose
Charlotte, North Carolina, 28210, United States
Cornerstone Eye Care
High Point, North Carolina, 27262, United States
Eye Care Associates of Greater Cincinnati
Cincinnati, Ohio, 45236, United States
Mark A. Terry, MD PC/ Devers Eye Institute
Portland, Oregon, 97210, United States
Bluestein Custom Vision
Charleston, South Carolina, 29414, United States
Carolinas Centers for Sight, PC
Florence, South Carolina, 29501, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701, United States
Keystone Clinical Research
Austin, Texas, 78731, United States
Houston Eye Associates
Houston, Texas, 77025, United States
Whitsett Vision Group
Houston, Texas, 77055, United States
Medical Center Opth. Assoc.
San Antonio, Texas, 78240, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head,
- Organization
- Allergan, Inc
Study Officials
- STUDY DIRECTOR
Medical Director
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2015
First Posted
May 6, 2015
Study Start
June 1, 2015
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
April 5, 2019
Results First Posted
April 5, 2019
Record last verified: 2019-03