Safety Study of Lifitegrast to Treat Dry Eye (SONATA)

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ClinicalTrials.gov Identifier: NCT01636206

Recruitment Status : Completed

First Posted : July 10, 2012

Results First Posted : October 3, 2016

Last Update Posted : June 11, 2021

Sponsor:

Information provided by (Responsible Party):

Takeda ( Shire )

Study Description

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

Study Design

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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

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo Placebo	Drug: Placebo Dosage Form: Ophthalmic Solution Dosage: placebo Frequency: BID Duration: ~1 year
Experimental: Lifitegrast Active	Drug: Lifitegrast Dosage Form: Ophthalmic Solution Dosage: 5.0% Frequency: BID Duration: ~1 year

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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

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)

Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01636206

Locations

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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

Shire

Investigators

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Study Director:	Study Director	Takeda

More Information

Publications of Results:

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.

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Responsible Party:	Shire
ClinicalTrials.gov 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 Keratoconjunctivitis Conjunctivitis	Conjunctival Diseases Keratitis Corneal Diseases Lifitegrast Ophthalmic Solutions Pharmaceutical Solutions

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