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Safety Study of Lifitegrast to Treat Dry Eye (SONATA)

Primary Purpose

Dry Eye Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Lifitegrast
Placebo
Sponsored by
Shire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • SONATA Investigational Site
  • SONATA Investigational Site
  • SONATA Investigational Site
  • SONATA Investigational Site
  • SONATA Investigational Site
  • SONATA Investigational Site
  • SONATA Investigational Site
  • SONATA Investigational Site
  • SONATA Investigational Site
  • SONATA Investigational Site
  • SONATA Investigational Site
  • SONATA Investigational Site
  • SONATA Investigational Site
  • SONATA Investigational Site
  • SONATA Investigational Site
  • SONATA Investigational Site
  • SONATA Investigational Site
  • SONATA Investigational Site
  • SONATA Investigational Site
  • SONATA Investigational Site
  • SONATA Investigational Site
  • SONATA Investigational Site
  • SONATA Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Lifitegrast

Arm Description

Placebo

Active

Outcomes

Primary Outcome Measures

Number of Participants With Ocular and Nonocular Treatment Emergent Adverse Events (TEAEs) for 1 Year

Secondary Outcome Measures

Full Information

First Posted
July 5, 2012
Last Updated
June 2, 2021
Sponsor
Shire
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1. Study Identification

Unique Protocol Identification Number
NCT01636206
Brief Title
Safety Study of Lifitegrast to Treat Dry Eye
Acronym
SONATA
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

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
October 16, 2012 (Actual)
Primary Completion Date
March 3, 2014 (Actual)
Study Completion Date
March 3, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
332 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
Lifitegrast
Arm Type
Experimental
Arm Description
Active
Intervention Type
Drug
Intervention Name(s)
Lifitegrast
Intervention Description
Dosage Form: Ophthalmic Solution Dosage: 5.0% Frequency: BID Duration: ~1 year
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Dosage Form: Ophthalmic Solution Dosage: placebo Frequency: BID Duration: ~1 year
Primary Outcome Measure Information:
Title
Number of Participants With Ocular and Nonocular Treatment Emergent Adverse Events (TEAEs) for 1 Year
Time Frame
Day 0 to Day 360

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
SONATA Investigational Site
City
Artesia
State/Province
California
ZIP/Postal Code
90701
Country
United States
Facility Name
SONATA Investigational Site
City
Hemet
State/Province
California
ZIP/Postal Code
92545
Country
United States
Facility Name
SONATA Investigational Site
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
SONATA Investigational Site
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
SONATA Investigational Site
City
Montebello
State/Province
California
ZIP/Postal Code
90640
Country
United States
Facility Name
SONATA Investigational Site
City
Parker
State/Province
Colorado
ZIP/Postal Code
80134
Country
United States
Facility Name
SONATA Investigational Site
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Facility Name
SONATA Investigational Site
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
SONATA Investigational Site
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
SONATA Investigational Site
City
Edgewood
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
SONATA Investigational Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
SONATA Investigational Site
City
Stillwater
State/Province
Minnesota
ZIP/Postal Code
55082
Country
United States
Facility Name
SONATA Investigational Site
City
Pennington
State/Province
New Jersey
ZIP/Postal Code
08534
Country
United States
Facility Name
SONATA Investigational Site
City
Woodland Park
State/Province
New Jersey
ZIP/Postal Code
07424
Country
United States
Facility Name
SONATA Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
SONATA Investigational Site
City
Rockville Centre
State/Province
New York
ZIP/Postal Code
11570
Country
United States
Facility Name
SONATA Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
SONATA Investigational Site
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
SONATA Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44115
Country
United States
Facility Name
SONATA Investigational Site
City
Doylestown
State/Province
Pennsylvania
ZIP/Postal Code
18902
Country
United States
Facility Name
SONATA Investigational Site
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
SONATA Investigational Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37411
Country
United States
Facility Name
SONATA Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77204
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27055211
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.
Results Reference
result

Learn more about this trial

Safety Study of Lifitegrast to Treat Dry Eye

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