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Safety Study of Lifitegrast to Treat Dry Eye (SONATA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01636206
First Posted: July 10, 2012
Last Update Posted: February 23, 2017
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.
Information provided by (Responsible Party):
Shire
July 5, 2012
July 10, 2012
August 9, 2016
October 3, 2016
February 23, 2017
July 2012
March 2014   (Final data collection date for primary outcome measure)
Number of Participants With Ocular and Nonocular Treatment Emergent Adverse Events (TEAEs) for 1 Year [ Time Frame: Day 0 to Day 360 ]
The Safety of Lifitegrast as assessed by ocular and Non-Ocular AEs [ Time Frame: 1 year ]
Complete list of historical versions of study NCT01636206 on ClinicalTrials.gov Archive Site
Not Provided
Ocular Safety Measures [ Time Frame: 1 year ]
Not Provided
Not Provided
 
Safety Study of Lifitegrast to Treat Dry Eye
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Dry Eye
  • Drug: Lifitegrast
    Dosage Form: Ophthalmic Solution Dosage: 5.0% Frequency: BID Duration: ~1 year
  • Drug: Placebo
    Dosage Form: Ophthalmic Solution Dosage: placebo Frequency: BID Duration: ~1 year
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
  • Experimental: Lifitegrast
    Active
    Intervention: Drug: Lifitegrast
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
332
March 2014
March 2014   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01636206
1118-DRY-400
No
Not Provided
Not Provided
Shire
Shire
Not Provided
Study Director: Charles Semba, MD SARcode Bioscience, Inc.
Shire
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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