Safety Study of Lifitegrast to Treat Dry Eye

Dry Eye Disease Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01636206
• Other study ID #: 1118-DRY-400
• Status: Completed
• Phase: Phase 3
• Start date: October 16, 2012
• Est. completion date: March 3, 2014

Study information

• Verified date: June 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 332
• Est. completion date: March 3, 2014
• Est. primary completion date: March 3, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Lifitegrast
Dosage Form: Ophthalmic Solution Dosage: 5.0% Frequency: BID Duration: ~1 year
• Placebo
Dosage Form: Ophthalmic Solution Dosage: placebo Frequency: BID Duration: ~1 year

Locations

Country	Name	City	State
United States	SONATA Investigational Site	Artesia	California
United States	SONATA Investigational Site	Boynton Beach	Florida
United States	SONATA Investigational Site	Charlotte	North Carolina
United States	SONATA Investigational Site	Chattanooga	Tennessee
United States	SONATA Investigational Site	Cleveland	Ohio
United States	SONATA Investigational Site	Doylestown	Pennsylvania
United States	SONATA Investigational Site	Edgewood	Kentucky
United States	SONATA Investigational Site	Hemet	California
United States	SONATA Investigational Site	High Point	North Carolina
United States	SONATA Investigational Site	Hoffman Estates	Illinois
United States	SONATA Investigational Site	Houston	Texas
United States	SONATA Investigational Site	Laguna Hills	California
United States	SONATA Investigational Site	Lancaster	California
United States	SONATA Investigational Site	Lexington	Kentucky
United States	SONATA Investigational Site	Montebello	California
United States	SONATA Investigational Site	Mount Pleasant	South Carolina
United States	SONATA Investigational Site	Parker	Colorado
United States	SONATA Investigational Site	Pennington	New Jersey
United States	SONATA Investigational Site	Rochester	New York
United States	SONATA Investigational Site	Rockville Centre	New York
United States	SONATA Investigational Site	Roswell	Georgia
United States	SONATA Investigational Site	Stillwater	Minnesota
United States	SONATA Investigational Site	Woodland Park	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

United States, 

References & Publications (1)

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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Ocular and Nonocular Treatment Emergent Adverse Events (TEAEs) for 1 Year		Day 0 to Day 360