Clinical trial NCT01636206: Safety Study of Lifitegrast to Treat Dry Eye
Official title: A Phase 3, Multicenter, Randomized, Double-Masked and Placebo-Controlled Study Evaluating the Safety of a 5.0% Concentration of Lifitegrast Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye (SONATA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Disease
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2012-07-10
Enrollment: 332
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 of lifitegrast ophthalmic solution compared to placebo in the treatment of dry eye as assessed by ocular and non-ocular adverse events when administered BID for approximately 1 year.


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

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 24h prior to Visit 1 and for some duration during 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 during the appropriate pre-study washout period and 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 Visit 1, and/or any other ocular surgical procedure within 12 months prior to Visit 1; 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: Number of Participants With Ocular and Nonocular Treatment Emergent Adverse Events (TEAEs) for 1 Year
timeFrame: Day 0 to Day 360
Secondary outcomes:
Other outcomes:
Locations:
city: Artesia
country: United States
facility: SONATA Investigational Site
state: California
city: Hemet
country: United States
facility: SONATA Investigational Site
state: California
city: Laguna Hills
country: United States
facility: SONATA Investigational Site
state: California
city: Lancaster
country: United States
facility: SONATA Investigational Site
state: California
city: Montebello
country: United States
facility: SONATA Investigational Site
state: California
city: Parker
country: United States
facility: SONATA Investigational Site
state: Colorado
city: Boynton Beach
country: United States
facility: SONATA Investigational Site
state: Florida
city: Roswell
country: United States
facility: SONATA Investigational Site
state: Georgia
city: Hoffman Estates
country: United States
facility: SONATA Investigational Site
state: Illinois
city: Edgewood
country: United States
facility: SONATA Investigational Site
state: Kentucky
city: Lexington
country: United States
facility: SONATA Investigational Site
state: Kentucky
city: Stillwater
country: United States
facility: SONATA Investigational Site
state: Minnesota
city: Pennington
country: United States
facility: SONATA Investigational Site
state: New Jersey
city: Woodland Park
country: United States
facility: SONATA Investigational Site
state: New Jersey
city: Rochester
country: United States
facility: SONATA Investigational Site
state: New York
city: Rockville Centre
country: United States
facility: SONATA Investigational Site
state: New York
city: Charlotte
country: United States
facility: SONATA Investigational Site
state: North Carolina
city: High Point
country: United States
facility: SONATA Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: SONATA Investigational Site
state: Ohio
city: Doylestown
country: United States
facility: SONATA Investigational Site
state: Pennsylvania
city: Mount Pleasant
country: United States
facility: SONATA Investigational Site
state: South Carolina
city: Chattanooga
country: United States
facility: SONATA Investigational Site
state: Tennessee
city: Houston
country: United States
facility: SONATA Investigational Site
state: Texas
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Donnenfeld ED, Karpecki PM, Majmudar PA, Nichols KK, Raychaudhuri A, Roy M, Semba CP. Safety of Lifitegrast Ophthalmic Solution 5.0% in Patients With Dry Eye Disease: A 1-Year, Multicenter, Randomized, Placebo-Controlled Study. Cornea. 2016 Jun;35(6):741-8. doi: 10.1097/ICO.0000000000000803.