Safety Study of Lifitegrast to Treat Dry Eye - Full Text View

Purpose

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.

Condition	Intervention	Phase
Dry Eye	Drug: Lifitegrast Drug: Placebo	Phase 3


Study Type:	Interventional
Study Design:	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)

Resource links provided by NLM:

Drug Information available for: Lifitegrast

U.S. FDA Resources

Further study details as provided by Shire:

Primary Outcome Measures:

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


Enrollment:	332
Study Start Date:	July 2012
Study Completion Date:	March 2014
Primary Completion Date:	March 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01636206

Show 23 Study Locations

Sponsors and Collaborators

Shire

Investigators


Study Director:	Charles Semba, MD	SARcode Bioscience, Inc.

More Information


Responsible Party:	Shire
ClinicalTrials.gov Identifier:	NCT01636206 History of Changes
Other Study ID Numbers:	1118-DRY-400
Study First Received:	July 5, 2012
Results First Received:	August 9, 2016
Last Updated:	January 5, 2017

Additional relevant MeSH terms:


Keratoconjunctivitis Sicca Dry Eye Syndromes Keratoconjunctivitis Conjunctivitis Conjunctival Diseases Eye Diseases	Keratitis Corneal Diseases Lacrimal Apparatus Diseases Ophthalmic Solutions Pharmaceutical Solutions

ClinicalTrials.gov processed this record on August 22, 2017

Safety Study of Lifitegrast to Treat Dry Eye (SONATA)