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

Dry Eye Syndromes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02435914
• Other study ID #: 223575-002
• Status: Completed
• Phase: Phase 2
• Start date: June 2015
• Est. completion date: January 2016

Study information

• Verified date: March 2019
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score Using a 5-Point Scale	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.	Baseline, Day 14
Secondary	Change From Baseline in Corneal Staining Score of the Study Eye Using a 6-Point Scale	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.	Baseline, Day 14
Secondary	Percentage of Participants With Complete Redness Response (Yes/No) in the Study Eye	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).	Day 14