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A Phase 3 Study to Evaluate the Efficacy of Lifitegrast in Subjects With Dry Eye

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 focused on measuring SAR 1118

Eligibility Criteria

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

Inclusion Criteria:

  • Willing and able to read, sign and date the informed consent and HIPAA documents
  • Willing and able to comply with all study procedures
  • Be at least 18 years of age
  • Patient-reported history of dry eye in both eyes
  • A negative urine pregnancy test if female of childbearing potential and must use adequate birth control throughout the study period
  • Artificial tear use within the past 30 days

Exclusion Criteria:

  • Any ocular condition that, in the opinion of the Investigator, could affect study parameters including, but not limited to, active ocular infection, ocular inflammation, glaucoma, and/or diabetic retinopathy
  • Unwilling to avoid wearing contact lenses for 7 days prior to first visit and for the duration of the study
  • Any blood donation or significant loss of blood within 56 days of Visit 1
  • Any history of immunodeficiency disorder, positive HIV, hepatitis B, C, or evidence of acute active hepatitis A (anti-HAV IgM), or organ or bone marrow transplant.
  • Use of any prohibited medications at any time during the study unless otherwise specified
  • Any significant illness that could interfere with study parameters
  • History of laser assisted in situ keratomileusis (LASIK) or similar type of corneal refractive surgery within 12 months prior to first visit, and/or any other ocular surgical procedure within 12 months prior to first visit; or any scheduled ocular surgical procedure during the study period.
  • Known history of alcohol and/or drug abuse
  • Subjects with Dry eye secondary to scarring or destruction of conjunctival goblet cells (as with Vitamin A deficiency)

Sites / Locations

  • OPUS-2 Investigational Site
  • OPUS-2 Investigational Site
  • OPUS-2 Investigational Site
  • OPUS-2 Investigational Site
  • OPUS-2 Investigational Site
  • OPUS-2 Investigational Site
  • OPUS-2 Investigational Site
  • OPUS-2 Investigational SIte
  • OPUS-2 Investigational Site
  • OPUS-2 Investigational Site
  • OPUS-2 Investigational Site
  • OPUS-2 Investigational Site
  • OPUS-2 Investigational Site
  • OPUS-2 Investigational Site
  • OPUS-2 Investigational Site
  • OPUS-2 Investigational Site
  • OPUS-2 Investigational Site
  • OPUS-2 Investigational Site
  • OPUS-2 Investigational Site
  • OPUS-2 Investigational Site
  • OPUS-2 Investigational Site
  • OPUS-2 Investigational Site
  • OPUS-2 Investigational Site
  • OPUS-2 Investigational Site
  • OPUS-2 Investigational Site
  • OPUS-2 Investigational Site
  • OPUS-2 Investigational Site
  • OPUS-2 Investigational Site
  • OPUS-2 Investigational Site
  • OPUS-2 Investigational Site
  • OPUS-2 Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lifitegrast

Placebo

Arm Description

Lifitegrast Ophthalmic Solution (5.0%)

Outcomes

Primary Outcome Measures

Change From Baseline in Inferior Corneal Fluorescein Staining Score to Day 84
Corneal staining was performed to grade the degree of corneal epithelial cell injury as measured by fluorescence using slit-lamp examination. The corneal surface is divided into three regions: superior, central and inferior. The scores for each of these 3 regions ranged from 0 to 4 (0=no staining; 1=few/rare punctate lesions; 2=discrete and countable lesions; 3=lesions too numerous to count, but not coalescent; 4=coalescent) with 0.5 point increments, and lower scores indicate improvement. Inferior corneal fluorescein staining scores from the study eye only were reported. Study eye is the 'worse eye', defined as the eye with worse (higher) score at baseline.
Change From Baseline in Eye Dryness Score (Visual Analogue Scale) to Day 84
Eye dryness score was assessed on a visual analogue scale (a 7-item [burning/stinging, itching, foreign body sensation, eye discomfort, eye dryness, photophobia, and pain], participant-reported, symptom index) with scores ranging from 0 to 100 (0=no discomfort; 100=maximal discomfort) and lower scores indicate a better outcome.

Secondary Outcome Measures

Full Information

First Posted
December 3, 2012
Last Updated
June 2, 2021
Sponsor
Shire
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1. Study Identification

Unique Protocol Identification Number
NCT01743729
Brief Title
A Phase 3 Study to Evaluate the Efficacy of Lifitegrast in Subjects With Dry Eye
Official Title
A Phase 3, Multicenter, Randomized, Double-Masked and Placebo-Controlled Study Evaluating the Efficacy of a 5.0% Concentration of Lifitegrast Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Currently Using Artificial Tears (OPUS-2)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
December 7, 2012 (Actual)
Primary Completion Date
October 1, 2013 (Actual)
Study Completion Date
October 1, 2013 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to evaluate the safety and efficacy of lifitegrast ophthalmic solution compared to placebo in the treatment of dry eye.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease
Keywords
SAR 1118

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
720 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifitegrast
Arm Type
Experimental
Arm Description
Lifitegrast Ophthalmic Solution (5.0%)
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Lifitegrast
Other Intervention Name(s)
SAR 1118
Intervention Description
Lifitegrast Ophthalmic Solution 5.0%
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo for Lifitegrast Ophthalmic Solution 5.0%
Primary Outcome Measure Information:
Title
Change From Baseline in Inferior Corneal Fluorescein Staining Score to Day 84
Description
Corneal staining was performed to grade the degree of corneal epithelial cell injury as measured by fluorescence using slit-lamp examination. The corneal surface is divided into three regions: superior, central and inferior. The scores for each of these 3 regions ranged from 0 to 4 (0=no staining; 1=few/rare punctate lesions; 2=discrete and countable lesions; 3=lesions too numerous to count, but not coalescent; 4=coalescent) with 0.5 point increments, and lower scores indicate improvement. Inferior corneal fluorescein staining scores from the study eye only were reported. Study eye is the 'worse eye', defined as the eye with worse (higher) score at baseline.
Time Frame
Baseline to Day 84
Title
Change From Baseline in Eye Dryness Score (Visual Analogue Scale) to Day 84
Description
Eye dryness score was assessed on a visual analogue scale (a 7-item [burning/stinging, itching, foreign body sensation, eye discomfort, eye dryness, photophobia, and pain], participant-reported, symptom index) with scores ranging from 0 to 100 (0=no discomfort; 100=maximal discomfort) and lower scores indicate a better outcome.
Time Frame
Baseline to Day 84

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Willing and able to read, sign and date the informed consent and HIPAA documents Willing and able to comply with all study procedures Be at least 18 years of age Patient-reported history of dry eye in both eyes A negative urine pregnancy test if female of childbearing potential and must use adequate birth control throughout the study period Artificial tear use within the past 30 days Exclusion Criteria: Any ocular condition that, in the opinion of the Investigator, could affect study parameters including, but not limited to, active ocular infection, ocular inflammation, glaucoma, and/or diabetic retinopathy Unwilling to avoid wearing contact lenses for 7 days prior to first visit and for the duration of the study Any blood donation or significant loss of blood within 56 days of Visit 1 Any history of immunodeficiency disorder, positive HIV, hepatitis B, C, or evidence of acute active hepatitis A (anti-HAV IgM), or organ or bone marrow transplant. Use of any prohibited medications at any time during the study unless otherwise specified Any significant illness that could interfere with study parameters History of laser assisted in situ keratomileusis (LASIK) or similar type of corneal refractive surgery within 12 months prior to first visit, and/or any other ocular surgical procedure within 12 months prior to first visit; or any scheduled ocular surgical procedure during the study period. Known history of alcohol and/or drug abuse Subjects with Dry eye secondary to scarring or destruction of conjunctival goblet cells (as with Vitamin A deficiency)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
OPUS-2 Investigational Site
City
Artesia
State/Province
California
ZIP/Postal Code
90701
Country
United States
Facility Name
OPUS-2 Investigational Site
City
Hemet
State/Province
California
ZIP/Postal Code
92545
Country
United States
Facility Name
OPUS-2 Investigational Site
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
OPUS-2 Investigational Site
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
OPUS-2 Investigational Site
City
Montebello
State/Province
California
ZIP/Postal Code
90640
Country
United States
Facility Name
OPUS-2 Investigational Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
OPUS-2 Investigational Site
City
Petaluma
State/Province
California
ZIP/Postal Code
94954
Country
United States
Facility Name
OPUS-2 Investigational SIte
City
Rancho Cordova
State/Province
California
ZIP/Postal Code
95670
Country
United States
Facility Name
OPUS-2 Investigational Site
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
OPUS-2 Investigational Site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
OPUS-2 Investigational Site
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
OPUS-2 Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
OPUS-2 Investigational Site
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
OPUS-2 Investigational Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
OPUS-2 Investigational Site
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55082
Country
United States
Facility Name
OPUS-2 Investigational Site
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
OPUS-2 Investigational Site
City
Des Peres
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
OPUS-2 Investigational Site
City
Independence
State/Province
Missouri
ZIP/Postal Code
64055
Country
United States
Facility Name
OPUS-2 Investigational Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
OPUS-2 Investigational Site
City
Washington
State/Province
Missouri
ZIP/Postal Code
63090
Country
United States
Facility Name
OPUS-2 Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
OPUS-2 Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Facility Name
OPUS-2 Investigational Site
City
Wantagh
State/Province
New York
ZIP/Postal Code
11793
Country
United States
Facility Name
OPUS-2 Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44115
Country
United States
Facility Name
OPUS-2 Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19148
Country
United States
Facility Name
OPUS-2 Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
Facility Name
OPUS-2 Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77055
Country
United States
Facility Name
OPUS-2 Investigational Site
City
League City
State/Province
Texas
ZIP/Postal Code
77573
Country
United States
Facility Name
OPUS-2 Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
OPUS-2 Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
OPUS-2 Investigational Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26365210
Citation
Tauber J, Karpecki P, Latkany R, Luchs J, Martel J, Sall K, Raychaudhuri A, Smith V, Semba CP; OPUS-2 Investigators. Lifitegrast Ophthalmic Solution 5.0% versus Placebo for Treatment of Dry Eye Disease: Results of the Randomized Phase III OPUS-2 Study. Ophthalmology. 2015 Dec;122(12):2423-31. doi: 10.1016/j.ophtha.2015.08.001. Epub 2015 Sep 11.
Results Reference
result

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A Phase 3 Study to Evaluate the Efficacy of Lifitegrast in Subjects With Dry Eye

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