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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 Oct 17, 2026, 7:45 PM 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 16, 2012 (Actual)
Primary completion
Mar 3, 2014 (Actual)
Completion
Mar 3, 2014 (Actual)
Last update posted
Jun 11, 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 11, 2021 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01636206 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →