Safety Study of Lifitegrast to Treat Dry Eye (SONATA)

This study is currently recruiting participants.

Verified September 2012 by SARcode Bioscience

Sponsor:

Information provided by (Responsible Party):

SARcode Bioscience

ClinicalTrials.gov Identifier:

NCT01636206

First received: July 5, 2012

Last updated: September 18, 2012

Last verified: September 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 5, 2012

Last Updated Date

September 18, 2012

Start Date ^ICMJE

July 2012

Estimated Primary Completion Date

November 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The Safety of Lifitegrast as assessed by ocular and Non-Ocular AEs [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01636206 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Ocular Safety Measures [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Safety Study of Lifitegrast to Treat Dry Eye

Official Title ^ICMJE

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)

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Dry Eye

Intervention ^ICMJE

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

Study Arm (s)

Placebo Comparator: Placebo
Placebo

Intervention: Drug: Placebo
Experimental: Lifitegrast
Active

Intervention: Drug: Lifitegrast

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

300

Estimated Completion Date

December 2013

Estimated Primary Completion Date

November 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Thanh Hoang		thoang@protrials.com
Contact: Scott Birnhbaum		sbirnbaum@protrials.com

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01636206

Other Study ID Numbers ^ICMJE

1118-DRY-400

Has Data Monitoring Committee

Responsible Party

SARcode Bioscience

Study Sponsor ^ICMJE

SARcode Bioscience

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Charles Semba, MD

SARcode Bioscience, Inc.

Information Provided By

SARcode Bioscience

Verification Date

September 2012

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

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