Safety Study of Lifitegrast to Treat Dry Eye (SONATA)
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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. |
ClinicalTrials.gov Identifier: NCT01636206 |
Recruitment Status :
Completed
First Posted : July 10, 2012
Results First Posted : October 3, 2016
Last Update Posted : June 11, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dry Eye Disease | Drug: Lifitegrast Drug: Placebo | Phase 3 |
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 |

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

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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)

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
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 |
Study Director: | Study Director | Takeda |
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 |
Dry Eye Syndromes Keratoconjunctivitis Sicca Eye Diseases Lacrimal Apparatus Diseases Keratoconjunctivitis Conjunctivitis |
Conjunctival Diseases Keratitis Corneal Diseases Lifitegrast Ophthalmic Solutions Pharmaceutical Solutions |