Safety, Efficacy, Tolerability and Pharmacokinetics of AGN-223575 Ophthalmic Suspension in Patients With Dry Eye Disease
- Conditions
- Dry Eye Syndromes
- Interventions
- Drug: AGN-223575 ophthalmic solutionDrug: AGN-223575 vehicle ophthalmic solution
- Registration Number
- NCT02435914
- Lead Sponsor
- Allergan
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 236
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AGN-223575 Dose A AGN-223575 ophthalmic solution 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 Dose A AGN-223575 vehicle ophthalmic solution 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 Dose B AGN-223575 ophthalmic solution 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 Dose B AGN-223575 vehicle ophthalmic solution 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 Dose C AGN-223575 ophthalmic solution 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 Dose C AGN-223575 vehicle ophthalmic solution 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 Vehicle AGN-223575 vehicle ophthalmic solution 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.
- Primary Outcome Measures
Name Time Method Change From Baseline in Conjunctival Redness Score in the Study Eye Using a 5-Point Scale Baseline, Day 14 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score Using a 5-Point Scale Baseline, Day 14 OSDI questionnaire consists of 12 questions regarding ocular symptoms, environmental triggers, and vision-related functioning in patients with dry eye disease. The participants rate each question on a 5-point scale where: 0=none of the time to 4=all of the time. The scores are totaled over the 12 questions and normalized/converted to a total score of 0=no disability to 100=complete disability. Higher OSDI scores are associated with greater severity. A negative change from Baseline indicates improvement.
Change From Baseline in Corneal Staining Score of the Study Eye Using a 6-Point Scale Baseline, Day 14 The cornea is the transparent front part of the eye which covers the iris and pupil. Staining of the cornea following ocular administration of fluorescein dye was graded using a 6-point scale where: 0=no staining to 5=diffuse staining. The higher the grade score, the worse the dry eye severity. A negative change from Baseline indicates improvement.
Percentage of Participants With Complete Redness Response (Yes/No) in the Study Eye Day 14 A participant was considered a redness responder if the study quadrant redness score based on the Allergan Dry Eye Redness Scale in the study eye was 0=Normal (no redness).
Trial Locations
- Locations (28)
Eye Associates of Colorado Springs
🇺🇸Colorado Springs, Colorado, United States
Eye Care Associates of Greater Cincinnati
🇺🇸Cincinnati, Ohio, United States
Whitsett Vision Group
🇺🇸Houston, Texas, United States
Tufts Medical Center/ Tufts University School of Medicine
🇺🇸Boston, Massachusetts, United States
Houston Eye Associates
🇺🇸Houston, Texas, United States
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
Coastal Research Assoc. LLC
🇺🇸Roswell, Georgia, United States
West Coast Eye Institute
🇺🇸Lecanto, Florida, United States
Eye Care Centers Management, Inc.
🇺🇸Morrow, Georgia, United States
Kentucky Center for Vision
🇺🇸Lexington, Kentucky, United States
Durrie Vision
🇺🇸Overland Park, Kansas, United States
Chicago Cornea Consultants
🇺🇸Hoffman Estates, Illinois, United States
Moyes Eye Center
🇺🇸Kansas City, 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
Cornerstone Eye Care
🇺🇸High Point, North Carolina, United States
Bluestein Custom Vision
🇺🇸Charleston, South Carolina, United States
Carolinas Centers for Sight, PC
🇺🇸Florence, South Carolina, United States
Mark A. Terry, MD PC/ Devers Eye Institute
🇺🇸Portland, Oregon, United States
Keystone Clinical Research
🇺🇸Austin, Texas, United States
Medical Center Opth. Assoc.
🇺🇸San Antonio, Texas, United States
Ophthalmology Associates
🇺🇸Saint Louis, Missouri, United States
SE Clinical Research Associates, LLC/ Charolette Eye Ear Nose
🇺🇸Charlotte, North Carolina, United States
Black Hills Regional Eye Institute
🇺🇸Rapid City, South Dakota, United States