Clinical trial NCT01743729: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Disease
Keywords: SAR 1118
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2012-12-06
Enrollment: 720
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Change From Baseline in Inferior Corneal Fluorescein Staining Score to Day 84
timeFrame: Baseline to Day 84
measure: Change From Baseline in Eye Dryness Score (Visual Analogue Scale) to Day 84
timeFrame: Baseline to Day 84
Secondary outcomes:
Other outcomes:
Locations:
city: Artesia
country: United States
facility: OPUS-2 Investigational Site
state: California
city: Hemet
country: United States
facility: OPUS-2 Investigational Site
state: California
city: Lancaster
country: United States
facility: OPUS-2 Investigational Site
state: California
city: Mission Hills
country: United States
facility: OPUS-2 Investigational Site
state: California
city: Montebello
country: United States
facility: OPUS-2 Investigational Site
state: California
city: Newport Beach
country: United States
facility: OPUS-2 Investigational Site
state: California
city: Petaluma
country: United States
facility: OPUS-2 Investigational Site
state: California
city: Rancho Cordova
country: United States
facility: OPUS-2 Investigational SIte
state: California
city: Danbury
country: United States
facility: OPUS-2 Investigational Site
state: Connecticut
city: Fort Myers
country: United States
facility: OPUS-2 Investigational Site
state: Florida
city: Hoffman Estates
country: United States
facility: OPUS-2 Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: OPUS-2 Investigational Site
state: Indiana
city: New Albany
country: United States
facility: OPUS-2 Investigational Site
state: Indiana
city: Lexington
country: United States
facility: OPUS-2 Investigational Site
state: Kentucky
city: Saint Paul
country: United States
facility: OPUS-2 Investigational Site
state: Minnesota
city: Chesterfield
country: United States
facility: OPUS-2 Investigational Site
state: Missouri
city: Des Peres
country: United States
facility: OPUS-2 Investigational Site
state: Missouri
city: Independence
country: United States
facility: OPUS-2 Investigational Site
state: Missouri
city: Kansas City
country: United States
facility: OPUS-2 Investigational Site
state: Missouri
city: Washington
country: United States
facility: OPUS-2 Investigational Site
state: Missouri
city: New York
country: United States
facility: OPUS-2 Investigational Site
state: New York
city: New York
country: United States
facility: OPUS-2 Investigational Site
state: New York
city: Wantagh
country: United States
facility: OPUS-2 Investigational Site
state: New York
city: Cleveland
country: United States
facility: OPUS-2 Investigational Site
state: Ohio
city: Philadelphia
country: United States
facility: OPUS-2 Investigational Site
state: Pennsylvania
city: Houston
country: United States
facility: OPUS-2 Investigational Site
state: Texas
city: Houston
country: United States
facility: OPUS-2 Investigational Site
state: Texas
city: League City
country: United States
facility: OPUS-2 Investigational Site
state: Texas
city: San Antonio
country: United States
facility: OPUS-2 Investigational Site
state: Texas
city: San Antonio
country: United States
facility: OPUS-2 Investigational Site
state: Texas
city: Norfolk
country: United States
facility: OPUS-2 Investigational Site
state: Virginia
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
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.