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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndromes
• Intervention / Treatment: Drug: AGN-223575 ophthalmic solution; Drug: AGN-223575 vehicle ophthalmic solution

• Study Type: Interventional
• Enrollment (Actual): 236
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85003
      • Arizona Center for Clinical Trials
  • California
    • Glendale, California, United States, 91203
      • Specialty Eye Ctr. Med. Group
    • Newport Beach, California, United States, 92663
      • The Eye Research Foundation
    • Santa Ana, California, United States, 92705
      • WCCT Global
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • Eye Associates of Colorado Springs
  • Florida
    • Lecanto, Florida, United States, 34491
      • West Coast Eye Institute
  • Georgia
    • Morrow, Georgia, United States, 30260
      • Eye Care Centers Management, Inc.
    • Roswell, Georgia, United States, 30076
      • Coastal Research Assoc. LLC
  • Illinois
    • Hoffman Estates, Illinois, United States, 60169
      • Chicago Cornea Consultants
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Durrie Vision
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Kentucky Center for Vision
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center/ Tufts University School of Medicine
  • Missouri
    • Kansas City, Missouri, United States, 64154
      • Moyes Eye Center
    • Saint Louis, Missouri, United States, 63131
      • Ophthalmology Associates
    • Washington, Missouri, United States, 63090
      • Comprehensive Eye Care Ltd.
  • New York
    • New York, New York, United States, 10013
      • Raymond Fong MD, PC
    • Wantagh, New York, United States, 11793
      • South Shore Eye Care LLP
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • SE Clinical Research Associates, LLC/ Charolette Eye Ear Nose
    • High Point, North Carolina, United States, 27262
      • Cornerstone Eye Care
  • Ohio
    • Cincinnati, Ohio, United States, 45236
      • Eye Care Associates of Greater Cincinnati
  • Oregon
    • Portland, Oregon, United States, 97210
      • Mark A. Terry, MD PC/ Devers Eye Institute
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Bluestein Custom Vision
    • Florence, South Carolina, United States, 29501
      • Carolinas Centers for Sight, PC
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Black Hills Regional Eye Institute
  • Texas
    • Austin, Texas, United States, 78731
      • Keystone Clinical Research
    • Houston, Texas, United States, 77055
      • Whitsett Vision Group
    • Houston, Texas, United States, 77025
      • Houston Eye Associates
    • San Antonio, Texas, United States, 78240
      • Medical Center Opth. Assoc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: AGN-223575 ophthalmic solution; AGN-223575 ophthalmic solution once or twice daily; Drug: AGN-223575 vehicle ophthalmic solution; Vehicle to AGN22375 ophthalmic solution once or twice daily.
Experimental: 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.	Drug: AGN-223575 ophthalmic solution; AGN-223575 ophthalmic solution once or twice daily; Drug: AGN-223575 vehicle ophthalmic solution; Vehicle to AGN22375 ophthalmic solution once or twice daily.
Experimental: 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.	Drug: AGN-223575 ophthalmic solution; AGN-223575 ophthalmic solution once or twice daily; Drug: AGN-223575 vehicle ophthalmic solution; Vehicle to AGN22375 ophthalmic solution once or twice daily.
Placebo Comparator: 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.	Drug: AGN-223575 vehicle ophthalmic solution; Vehicle to AGN22375 ophthalmic solution once or twice daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Allergan

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: May 1, 2015
• First Submitted That Met QC Criteria: May 1, 2015
• First Posted (Estimate): May 6, 2015

Study Record Updates

• Last Update Posted (Actual): April 5, 2019
• Last Update Submitted That Met QC Criteria: March 15, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Ophthalmic Solutions; Pharmaceutical Solutions
• Other Study ID Numbers: 223575-002