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

Primary Purpose

Dry Eye Syndromes

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AGN-223575 ophthalmic solution
AGN-223575 vehicle ophthalmic solution
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndromes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Arizona Center for Clinical Trials
  • Specialty Eye Ctr. Med. Group
  • The Eye Research Foundation
  • WCCT Global
  • Eye Associates of Colorado Springs
  • West Coast Eye Institute
  • Eye Care Centers Management, Inc.
  • Coastal Research Assoc. LLC
  • Chicago Cornea Consultants
  • Durrie Vision
  • Kentucky Center for Vision
  • Tufts Medical Center/ Tufts University School of Medicine
  • Moyes Eye Center
  • Ophthalmology Associates
  • Comprehensive Eye Care Ltd.
  • Raymond Fong MD, PC
  • South Shore Eye Care LLP
  • SE Clinical Research Associates, LLC/ Charolette Eye Ear Nose
  • Cornerstone Eye Care
  • Eye Care Associates of Greater Cincinnati
  • Mark A. Terry, MD PC/ Devers Eye Institute
  • Bluestein Custom Vision
  • Carolinas Centers for Sight, PC
  • Black Hills Regional Eye Institute
  • Keystone Clinical Research
  • Houston Eye Associates
  • Whitsett Vision Group
  • Medical Center Opth. Assoc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

AGN-223575 Dose A

AGN-223575 Dose B

AGN-223575 Dose C

AGN-223575 Vehicle

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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).

Full Information

First Posted
May 1, 2015
Last Updated
March 15, 2019
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT02435914
Brief Title
Safety, Efficacy, Tolerability and Pharmacokinetics of AGN-223575 Ophthalmic Suspension in Patients With Dry Eye Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
236 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AGN-223575 Dose A
Arm Type
Experimental
Arm Description
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.
Arm Title
AGN-223575 Dose B
Arm Type
Experimental
Arm Description
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.
Arm Title
AGN-223575 Dose C
Arm Type
Experimental
Arm Description
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.
Arm Title
AGN-223575 Vehicle
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
AGN-223575 ophthalmic solution
Intervention Description
AGN-223575 ophthalmic solution once or twice daily
Intervention Type
Drug
Intervention Name(s)
AGN-223575 vehicle ophthalmic solution
Intervention Description
Vehicle to AGN22375 ophthalmic solution once or twice daily.
Primary Outcome Measure Information:
Title
Change From Baseline in Conjunctival Redness Score in the Study Eye Using a 5-Point Scale
Description
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.
Time Frame
Baseline, Day 14
Secondary Outcome Measure Information:
Title
Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score Using a 5-Point Scale
Description
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.
Time Frame
Baseline, Day 14
Title
Change From Baseline in Corneal Staining Score of the Study Eye Using a 6-Point Scale
Description
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.
Time Frame
Baseline, Day 14
Title
Percentage of Participants With Complete Redness Response (Yes/No) in the Study Eye
Description
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).
Time Frame
Day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Center for Clinical Trials
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85003
Country
United States
Facility Name
Specialty Eye Ctr. Med. Group
City
Glendale
State/Province
California
ZIP/Postal Code
91203
Country
United States
Facility Name
The Eye Research Foundation
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
WCCT Global
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Eye Associates of Colorado Springs
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
West Coast Eye Institute
City
Lecanto
State/Province
Florida
ZIP/Postal Code
34491
Country
United States
Facility Name
Eye Care Centers Management, Inc.
City
Morrow
State/Province
Georgia
ZIP/Postal Code
30260
Country
United States
Facility Name
Coastal Research Assoc. LLC
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Chicago Cornea Consultants
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Durrie Vision
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Kentucky Center for Vision
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Tufts Medical Center/ Tufts University School of Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Moyes Eye Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64154
Country
United States
Facility Name
Ophthalmology Associates
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Comprehensive Eye Care Ltd.
City
Washington
State/Province
Missouri
ZIP/Postal Code
63090
Country
United States
Facility Name
Raymond Fong MD, PC
City
New York
State/Province
New York
ZIP/Postal Code
10013
Country
United States
Facility Name
South Shore Eye Care LLP
City
Wantagh
State/Province
New York
ZIP/Postal Code
11793
Country
United States
Facility Name
SE Clinical Research Associates, LLC/ Charolette Eye Ear Nose
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Cornerstone Eye Care
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Eye Care Associates of Greater Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Mark A. Terry, MD PC/ Devers Eye Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Bluestein Custom Vision
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Carolinas Centers for Sight, PC
City
Florence
State/Province
South Carolina
ZIP/Postal Code
29501
Country
United States
Facility Name
Black Hills Regional Eye Institute
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Keystone Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Houston Eye Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Facility Name
Whitsett Vision Group
City
Houston
State/Province
Texas
ZIP/Postal Code
77055
Country
United States
Facility Name
Medical Center Opth. Assoc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States

12. IPD Sharing Statement

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

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