Completed PHASE3 INTERVENTIONAL 2-arm NCT01636206

Safety Study of Lifitegrast to Treat Dry Eye (SONATA)

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)

Sponsor: Shire

Conditions Dry Eye Disease

Interventions Lifitegrast Placebo

Updated 11 times since 2017 Last updated: Jun 2, 2021 Started: Oct 16, 2012 Primary completion: Mar 3, 2014 Completion: Mar 3, 2014

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Dry Eye Disease and is currently completed. Shire leads this study, which shows 11 recorded versions since 2012 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

11 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2023 — Jul 2024 [monthly]

Completed PHASE3
Dec 2022 — Jan 2023 [monthly]

Completed PHASE3

▶ Show 6 earlier versions

Sep 2021 — Dec 2022 [monthly]

Completed PHASE3
Jan 2021 — Sep 2021 [monthly]

Completed PHASE3
Jan 2019 — Jan 2021 [monthly]

Completed PHASE3
Jun 2018 — Jan 2019 [monthly]

Completed PHASE3
Feb 2017 — Jun 2018 [monthly]

Completed PHASE3
Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

Oct 2012

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Shire

Data source: Takeda

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Artesia, United States , Boynton Beach, United States , Charlotte, United States , Chattanooga, United States , Cleveland, United States , Doylestown, United States , Edgewood, United States , Hemet, United States , High Point, United States , Hoffman Estates, United States and 13 more locations