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A Study to Evaluate Efficacy and Safety of Lifitegrast in Subjects With Dry Eye (OPUS-3) (OPUS-3)

Primary Purpose

Dry Eye Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Lifitegrast
Placebo
Sponsored by
Shire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Disease

Eligibility Criteria

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

Inclusion Criteria:

  • Patient-reported history of Dry Eye Disease in both eyes.
  • Use of over the counter artificial tears within the past 30 days.
  • A negative urine pregnancy test for females and willingness to use adequate birth control throughout the study.
  • Able and willing to comply with all study procedures.

Exclusion Criteria:

  • Presence of an ocular condition that could affect the study parameters such as active ocular infections, ocular inflammation, glaucoma, or diabetic retinopathy;.
  • Unwilling to stop wearing contact lenses during the study.
  • LASIK or other ocular surgical procedures within 12 months prior to or during the study.
  • Use of prohibited medications
  • Significant medical conditions that could affect the study parameters.

Sites / Locations

  • University of Alabama at Birmingham, UAB School of Optometry
  • Arizona Eye Center
  • Sall Research Medical Center
  • United Medical Research Institute
  • North Valley Eye Medical Group, Inc
  • Montebello Medical Eye Center, Inc.
  • Eye Research Foundation
  • Arch Health Partners
  • Martel Eye Medical Group
  • Shasta Eye Medical Group, Inc.
  • West Coast Eye Care Associates
  • Chicago Cornea Consultants, Ltd.
  • Jackson Eye, SC
  • Price Vision Group
  • John-Kenyon American Eye Institute
  • Koffler Vision Group
  • The Eye Care Institute
  • Holpro Vision, Ltd.
  • Clinical Eye Research of Boston
  • Lifelong Vision Foundation
  • Tauber Eye Center
  • Tekwani Vision Center
  • Ophthalmology Consultants, Ltd.
  • Comprehensive Eye Care, Ltd.
  • Wellish Vision Institute
  • Abrams Eye Institute
  • Clinical Vision Research Center at SUNY
  • Ophthalmic Consultants Of Long Island
  • South Shore Eye Care, LLP
  • Abrams Eye Center
  • Scott & Christie and Associates, PC
  • Matossian Eye Associates
  • Toyos Clinic
  • The Cataract & Glaucoma Center
  • Advanced Laser Vision and Surgical Institute
  • Whitsett Vision Group
  • University of Houston College of Optometry
  • The Eye Clinic of Texas (Houston Eye Associates)
  • Eye Clinics of South Texas, P.A.
  • R and R Eye Research, LLC.
  • See Clearly Vision

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lifitegrast

Placebo

Arm Description

Lifitegrast Ophthalmic Solution 5%, BID for 84 days

Placebo to match active treatment, BID for 84 days

Outcomes

Primary Outcome Measures

Change From Baseline in Patient-Reported Eye Dryness Score to Day 84
Eye dryness score was scored on a Visual Analogue Scale (VAS) ranges from 0-100 (0=no discomfort; 100=maximal discomfort).

Secondary Outcome Measures

Change From Baseline in Patient-Reported Eye Dryness Score to Day 14 and Day 42
Eye dryness score was scored on a Visual Analogue Scale (VAS) ranges from 0-100 (0=no discomfort; 100=maximal discomfort).

Full Information

First Posted
October 30, 2014
Last Updated
June 2, 2021
Sponsor
Shire
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1. Study Identification

Unique Protocol Identification Number
NCT02284516
Brief Title
A Study to Evaluate Efficacy and Safety of Lifitegrast in Subjects With Dry Eye (OPUS-3)
Acronym
OPUS-3
Official Title
A Phase 3, Multicenter, Randomized, Double-masked, and Placebo-controlled Study Evaluating the Efficacy and Safety of a 5.0% Concentration of Lifitegrast Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Disease and History of Recent Artificial Tear Use
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
November 6, 2014 (Actual)
Primary Completion Date
October 5, 2015 (Actual)
Study Completion Date
October 5, 2015 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
Evaluate the efficacy and safety of Lifitegrast in subjects with dry eye disease and a recent history of artificial tear use.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
711 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifitegrast
Arm Type
Experimental
Arm Description
Lifitegrast Ophthalmic Solution 5%, BID for 84 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo to match active treatment, BID for 84 days
Intervention Type
Drug
Intervention Name(s)
Lifitegrast
Intervention Description
Lifitegrast Ophthalmic Solution 5%, BID for 84 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to match active treatment, BID for 84 days
Primary Outcome Measure Information:
Title
Change From Baseline in Patient-Reported Eye Dryness Score to Day 84
Description
Eye dryness score was scored on a Visual Analogue Scale (VAS) ranges from 0-100 (0=no discomfort; 100=maximal discomfort).
Time Frame
Baseline to Day 84
Secondary Outcome Measure Information:
Title
Change From Baseline in Patient-Reported Eye Dryness Score to Day 14 and Day 42
Description
Eye dryness score was scored on a Visual Analogue Scale (VAS) ranges from 0-100 (0=no discomfort; 100=maximal discomfort).
Time Frame
Baseline to Day 14 and Day 42

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient-reported history of Dry Eye Disease in both eyes. Use of over the counter artificial tears within the past 30 days. A negative urine pregnancy test for females and willingness to use adequate birth control throughout the study. Able and willing to comply with all study procedures. Exclusion Criteria: Presence of an ocular condition that could affect the study parameters such as active ocular infections, ocular inflammation, glaucoma, or diabetic retinopathy;. Unwilling to stop wearing contact lenses during the study. LASIK or other ocular surgical procedures within 12 months prior to or during the study. Use of prohibited medications Significant medical conditions that could affect the study parameters.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham, UAB School of Optometry
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Arizona Eye Center
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85225
Country
United States
Facility Name
Sall Research Medical Center
City
Artesia
State/Province
California
ZIP/Postal Code
90701
Country
United States
Facility Name
United Medical Research Institute
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Facility Name
North Valley Eye Medical Group, Inc
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Montebello Medical Eye Center, Inc.
City
Montebello
State/Province
California
ZIP/Postal Code
90640
Country
United States
Facility Name
Eye Research Foundation
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Arch Health Partners
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
Martel Eye Medical Group
City
Rancho Cordova
State/Province
California
ZIP/Postal Code
95670
Country
United States
Facility Name
Shasta Eye Medical Group, Inc.
City
Redding
State/Province
California
ZIP/Postal Code
96001
Country
United States
Facility Name
West Coast Eye Care Associates
City
San Diego
State/Province
California
ZIP/Postal Code
92115
Country
United States
Facility Name
Chicago Cornea Consultants, Ltd.
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Jackson Eye, SC
City
Lake Villa
State/Province
Illinois
ZIP/Postal Code
60046
Country
United States
Facility Name
Price Vision Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
John-Kenyon American Eye Institute
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Koffler Vision Group
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
The Eye Care Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Facility Name
Holpro Vision, Ltd.
City
Union
State/Province
Kentucky
ZIP/Postal Code
41091
Country
United States
Facility Name
Clinical Eye Research of Boston
City
Winchester
State/Province
Massachusetts
ZIP/Postal Code
01890
Country
United States
Facility Name
Lifelong Vision Foundation
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Tauber Eye Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Tekwani Vision Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Ophthalmology Consultants, Ltd.
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
Wellish Vision Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Abrams Eye Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Clinical Vision Research Center at SUNY
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Facility Name
Ophthalmic Consultants Of Long Island
City
Rockville Centre
State/Province
New York
ZIP/Postal Code
11570
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
Abrams Eye Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44115
Country
United States
Facility Name
Scott & Christie and Associates, PC
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Facility Name
Matossian Eye Associates
City
Doylestown
State/Province
Pennsylvania
ZIP/Postal Code
18902
Country
United States
Facility Name
Toyos Clinic
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
The Cataract & Glaucoma Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
Advanced Laser Vision and Surgical Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
Facility Name
Whitsett Vision Group
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Facility Name
University of Houston College of Optometry
City
Houston
State/Province
Texas
ZIP/Postal Code
77204
Country
United States
Facility Name
The Eye Clinic of Texas (Houston Eye Associates)
City
League City
State/Province
Texas
ZIP/Postal Code
77573
Country
United States
Facility Name
Eye Clinics of South Texas, P.A.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
R and R Eye Research, LLC.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
See Clearly Vision
City
McLean
State/Province
Virginia
ZIP/Postal Code
22012
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34617974
Citation
Holland EJ, Jackson MA, Donnenfeld E, Piccolo R, Cohen A, Barabino S, Rolando M, Figueiredo FC. Efficacy of Lifitegrast Ophthalmic Solution, 5.0%, in Patients With Moderate to Severe Dry Eye Disease: A Post Hoc Analysis of 2 Randomized Clinical Trials. JAMA Ophthalmol. 2021 Nov 1;139(11):1200-1208. doi: 10.1001/jamaophthalmol.2021.3943.
Results Reference
derived
PubMed Identifier
28079022
Citation
Holland EJ, Luchs J, Karpecki PM, Nichols KK, Jackson MA, Sall K, Tauber J, Roy M, Raychaudhuri A, Shojaei A. Lifitegrast for the Treatment of Dry Eye Disease: Results of a Phase III, Randomized, Double-Masked, Placebo-Controlled Trial (OPUS-3). Ophthalmology. 2017 Jan;124(1):53-60. doi: 10.1016/j.ophtha.2016.09.025. Epub 2016 Oct 27.
Results Reference
derived

Learn more about this trial

A Study to Evaluate Efficacy and Safety of Lifitegrast in Subjects With Dry Eye (OPUS-3)

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