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Safety Study of Lifitegrast to Treat Dry Eye (SONATA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01636206
Recruitment Status : Completed
First Posted : July 10, 2012
Results First Posted : October 3, 2016
Last Update Posted : June 11, 2021
Information provided by (Responsible Party):
Takeda ( Shire )

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.

Condition or disease Intervention/treatment Phase
Dry Eye Disease Drug: Lifitegrast Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 332 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : October 16, 2012
Actual Primary Completion Date : March 3, 2014
Actual Study Completion Date : March 3, 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Lifitegrast

Arm Intervention/treatment
Placebo Comparator: Placebo
Drug: Placebo
Dosage Form: Ophthalmic Solution Dosage: placebo Frequency: BID Duration: ~1 year

Experimental: Lifitegrast
Drug: Lifitegrast
Dosage Form: Ophthalmic Solution Dosage: 5.0% Frequency: BID Duration: ~1 year

Primary Outcome Measures :
  1. Number of Participants With Ocular and Nonocular Treatment Emergent Adverse Events (TEAEs) for 1 Year [ Time Frame: Day 0 to Day 360 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01636206

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United States, California
SONATA Investigational Site
Artesia, California, United States, 90701
SONATA Investigational Site
Hemet, California, United States, 92545
SONATA Investigational Site
Laguna Hills, California, United States, 92653
SONATA Investigational Site
Lancaster, California, United States, 93534
SONATA Investigational Site
Montebello, California, United States, 90640
United States, Colorado
SONATA Investigational Site
Parker, Colorado, United States, 80134
United States, Florida
SONATA Investigational Site
Boynton Beach, Florida, United States, 33426
United States, Georgia
SONATA Investigational Site
Roswell, Georgia, United States, 30076
United States, Illinois
SONATA Investigational Site
Hoffman Estates, Illinois, United States, 60169
United States, Kentucky
SONATA Investigational Site
Edgewood, Kentucky, United States, 41017
SONATA Investigational Site
Lexington, Kentucky, United States, 40509
United States, Minnesota
SONATA Investigational Site
Stillwater, Minnesota, United States, 55082
United States, New Jersey
SONATA Investigational Site
Pennington, New Jersey, United States, 08534
SONATA Investigational Site
Woodland Park, New Jersey, United States, 07424
United States, New York
SONATA Investigational Site
Rochester, New York, United States, 14618
SONATA Investigational Site
Rockville Centre, New York, United States, 11570
United States, North Carolina
SONATA Investigational Site
Charlotte, North Carolina, United States, 28210
SONATA Investigational Site
High Point, North Carolina, United States, 27262
United States, Ohio
SONATA Investigational Site
Cleveland, Ohio, United States, 44115
United States, Pennsylvania
SONATA Investigational Site
Doylestown, Pennsylvania, United States, 18902
United States, South Carolina
SONATA Investigational Site
Mount Pleasant, South Carolina, United States, 29464
United States, Tennessee
SONATA Investigational Site
Chattanooga, Tennessee, United States, 37411
United States, Texas
SONATA Investigational Site
Houston, Texas, United States, 77204
Sponsors and Collaborators
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Study Director: Study Director Takeda
Publications of Results:
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Responsible Party: Shire Identifier: NCT01636206    
Other Study ID Numbers: 1118-DRY-400
First Posted: July 10, 2012    Key Record Dates
Results First Posted: October 3, 2016
Last Update Posted: June 11, 2021
Last Verified: June 2021
Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Eye Diseases
Lacrimal Apparatus Diseases
Conjunctival Diseases
Corneal Diseases
Ophthalmic Solutions
Pharmaceutical Solutions