Safety Study of Lifitegrast to Treat Dry Eye (SONATA)

June 2, 2021 updated by: Shire

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

332

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • 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
        • SONATA Investigational Site
    • Colorado
      • Parker, Colorado, United States, 80134
        • SONATA Investigational Site
    • Florida
      • Boynton Beach, Florida, United States, 33426
        • SONATA Investigational Site
    • Georgia
      • Roswell, Georgia, United States, 30076
        • SONATA Investigational Site
    • Illinois
      • Hoffman Estates, Illinois, United States, 60169
        • SONATA Investigational Site
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • SONATA Investigational Site
      • Lexington, Kentucky, United States, 40509
        • SONATA Investigational Site
    • Minnesota
      • Stillwater, Minnesota, United States, 55082
        • SONATA Investigational Site
    • New Jersey
      • Pennington, New Jersey, United States, 08534
        • SONATA Investigational Site
      • Woodland Park, New Jersey, United States, 07424
        • SONATA Investigational Site
    • New York
      • Rochester, New York, United States, 14618
        • SONATA Investigational Site
      • Rockville Centre, New York, United States, 11570
        • SONATA Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • SONATA Investigational Site
      • High Point, North Carolina, United States, 27262
        • SONATA Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44115
        • SONATA Investigational Site
    • Pennsylvania
      • Doylestown, Pennsylvania, United States, 18902
        • SONATA Investigational Site
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
        • SONATA Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37411
        • SONATA Investigational Site
    • Texas
      • Houston, Texas, United States, 77204
        • SONATA Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shire

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2012

Primary Completion (Actual)

March 3, 2014

Study Completion (Actual)

March 3, 2014

Study Registration Dates

First Submitted

July 5, 2012

First Submitted That Met QC Criteria

July 5, 2012

First Posted (Estimate)

July 10, 2012

Study Record Updates

Last Update Posted (Actual)

June 11, 2021

Last Update Submitted That Met QC Criteria

June 2, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1118-DRY-400

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dry Eye Disease

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Czech Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe