A Phase 3 Study to Evaluate the Efficacy of Lifitegrast in Subjects With Dry Eye
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)
1 other identifier
interventional
720
1 country
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2012
Shorter than P25 for phase_3
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 3, 2012
CompletedFirst Posted
Study publicly available on registry
December 6, 2012
CompletedStudy Start
First participant enrolled
December 7, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedResults Posted
Study results publicly available
February 24, 2017
CompletedJune 23, 2021
June 1, 2021
10 months
December 3, 2012
August 9, 2016
June 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Baseline to Day 84
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.
Baseline to Day 84
Study Arms (2)
Lifitegrast
EXPERIMENTALLifitegrast Ophthalmic Solution (5.0%)
Placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (31)
OPUS-2 Investigational Site
Artesia, California, 90701, United States
OPUS-2 Investigational Site
Hemet, California, 92545, United States
OPUS-2 Investigational Site
Lancaster, California, 93534, United States
OPUS-2 Investigational Site
Mission Hills, California, 91345, United States
OPUS-2 Investigational Site
Montebello, California, 90640, United States
OPUS-2 Investigational Site
Newport Beach, California, 92663, United States
OPUS-2 Investigational Site
Petaluma, California, 94954, United States
OPUS-2 Investigational SIte
Rancho Cordova, California, 95670, United States
OPUS-2 Investigational Site
Danbury, Connecticut, 06810, United States
OPUS-2 Investigational Site
Fort Myers, Florida, 33901, United States
OPUS-2 Investigational Site
Hoffman Estates, Illinois, 60169, United States
OPUS-2 Investigational Site
Indianapolis, Indiana, 46260, United States
OPUS-2 Investigational Site
New Albany, Indiana, 47150, United States
OPUS-2 Investigational Site
Lexington, Kentucky, 40509, United States
OPUS-2 Investigational Site
Saint Paul, Minnesota, 55082, United States
OPUS-2 Investigational Site
Chesterfield, Missouri, 63017, United States
OPUS-2 Investigational Site
Des Peres, Missouri, 63131, United States
OPUS-2 Investigational Site
Independence, Missouri, 64055, United States
OPUS-2 Investigational Site
Kansas City, Missouri, 64111, United States
OPUS-2 Investigational Site
Washington, Missouri, 63090, United States
OPUS-2 Investigational Site
New York, New York, 10016, United States
OPUS-2 Investigational Site
New York, New York, 10036, United States
OPUS-2 Investigational Site
Wantagh, New York, 11793, United States
OPUS-2 Investigational Site
Cleveland, Ohio, 44115, United States
OPUS-2 Investigational Site
Philadelphia, Pennsylvania, 19148, United States
OPUS-2 Investigational Site
Houston, Texas, 77034, United States
OPUS-2 Investigational Site
Houston, Texas, 77055, United States
OPUS-2 Investigational Site
League City, Texas, 77573, United States
OPUS-2 Investigational Site
San Antonio, Texas, 78209, United States
OPUS-2 Investigational Site
San Antonio, Texas, 78229, United States
OPUS-2 Investigational Site
Norfolk, Virginia, 23502, United States
Related Publications (1)
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.
PMID: 26365210RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Shire (Note: Lifitegrast was divested to Novartis in 2019)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2012
First Posted
December 6, 2012
Study Start
December 7, 2012
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
June 23, 2021
Results First Posted
February 24, 2017
Record last verified: 2021-06