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Completed Phase 3 Interventional Results available

Safety Study of Lifitegrast to Treat Dry Eye

ClinicalTrials.gov ID: NCT01636206

Public ClinicalTrials.gov record NCT01636206. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 4:35 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT01636206
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Shire
Industry
Enrollment
332 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 15, 2012
Primary completion
Mar 2, 2014
Completion
Mar 2, 2014
Last update posted
Jun 10, 2021

2012 – 2014

United States locations

U.S. sites
23
U.S. states
15
U.S. cities
23
Facility City State ZIP Site status
SONATA Investigational Site Artesia California 90701
SONATA Investigational Site Hemet California 92545
SONATA Investigational Site Laguna Hills California 92653
SONATA Investigational Site Lancaster California 93534
SONATA Investigational Site Montebello California 90640
SONATA Investigational Site Parker Colorado 80134
SONATA Investigational Site Boynton Beach Florida 33426
SONATA Investigational Site Roswell Georgia 30076
SONATA Investigational Site Hoffman Estates Illinois 60169
SONATA Investigational Site Edgewood Kentucky 41017
SONATA Investigational Site Lexington Kentucky 40509
SONATA Investigational Site Stillwater Minnesota 55082
SONATA Investigational Site Pennington New Jersey 08534
SONATA Investigational Site Woodland Park New Jersey 07424
SONATA Investigational Site Rochester New York 14618
SONATA Investigational Site Rockville Centre New York 11570
SONATA Investigational Site Charlotte North Carolina 28210
SONATA Investigational Site High Point North Carolina 27262
SONATA Investigational Site Cleveland Ohio 44115
SONATA Investigational Site Doylestown Pennsylvania 18902
SONATA Investigational Site Mt. Pleasant South Carolina 29464
SONATA Investigational Site Chattanooga Tennessee 37411
SONATA Investigational Site Houston Texas 77204

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01636206, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 10, 2021 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01636206 live on ClinicalTrials.gov.

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