Safety Study of Lifitegrast to Treat Dry Eye
SONATA
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)
1 other identifier
interventional
332
1 country
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2012
23 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
July 5, 2012
CompletedFirst Posted
Study publicly available on registry
July 10, 2012
CompletedStudy Start
First participant enrolled
October 16, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 3, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 3, 2014
CompletedResults Posted
Study results publicly available
October 3, 2016
CompletedJune 11, 2021
June 1, 2021
1.4 years
July 5, 2012
August 9, 2016
June 2, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Ocular and Nonocular Treatment Emergent Adverse Events (TEAEs) for 1 Year
Day 0 to Day 360
Study Arms (2)
Placebo
PLACEBO COMPARATORPlacebo
Lifitegrast
EXPERIMENTALActive
Interventions
Dosage Form: Ophthalmic Solution Dosage: 5.0% Frequency: BID Duration: \~1 year
Dosage Form: Ophthalmic Solution Dosage: placebo Frequency: BID Duration: \~1 year
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
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 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (23)
SONATA Investigational Site
Artesia, California, 90701, United States
SONATA Investigational Site
Hemet, California, 92545, United States
SONATA Investigational Site
Laguna Hills, California, 92653, United States
SONATA Investigational Site
Lancaster, California, 93534, United States
SONATA Investigational Site
Montebello, California, 90640, United States
SONATA Investigational Site
Parker, Colorado, 80134, United States
SONATA Investigational Site
Boynton Beach, Florida, 33426, United States
SONATA Investigational Site
Roswell, Georgia, 30076, United States
SONATA Investigational Site
Hoffman Estates, Illinois, 60169, United States
SONATA Investigational Site
Edgewood, Kentucky, 41017, United States
SONATA Investigational Site
Lexington, Kentucky, 40509, United States
SONATA Investigational Site
Stillwater, Minnesota, 55082, United States
SONATA Investigational Site
Pennington, New Jersey, 08534, United States
SONATA Investigational Site
Woodland Park, New Jersey, 07424, United States
SONATA Investigational Site
Rochester, New York, 14618, United States
SONATA Investigational Site
Rockville Centre, New York, 11570, United States
SONATA Investigational Site
Charlotte, North Carolina, 28210, United States
SONATA Investigational Site
High Point, North Carolina, 27262, United States
SONATA Investigational Site
Cleveland, Ohio, 44115, United States
SONATA Investigational Site
Doylestown, Pennsylvania, 18902, United States
SONATA Investigational Site
Mt. Pleasant, South Carolina, 29464, United States
SONATA Investigational Site
Chattanooga, Tennessee, 37411, United States
SONATA Investigational Site
Houston, Texas, 77204, United States
Related Publications (1)
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.
PMID: 27055211RESULT
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
July 5, 2012
First Posted
July 10, 2012
Study Start
October 16, 2012
Primary Completion
March 3, 2014
Study Completion
March 3, 2014
Last Updated
June 11, 2021
Results First Posted
October 3, 2016
Record last verified: 2021-06