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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)

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Trial Profile

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)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Jun 2021

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At a glance

  • Drugs Lifitegrast (Primary)
  • Indications Dry eyes
  • Focus Adverse reactions; Registrational
  • Acronyms SONATA
  • Sponsors SARcode Bioscience; Shire

    • Most Recent Events

    • 29 Jun 2020 According to a Takeda media release, Novartis Europharm Limiteds (Novartis) has withdrawn the Marketing Authorisation Application (MAA) for Xiidra (lifitegrast ophthalmic solution) 5% product (Xiidra) in Europe, as posted on the European Medicines Agencys website on 26th Jun 2020.
    • 03 Jan 2018 According to a Shire plc media release, Xiidra (lifitegrast ophthalmic solution 5%) has been approved in Canada for the treatment of dry eye disease based on results from five trials including this one.
    • 15 Aug 2017 According to a Shire media release, based on the data from this and other four trials (see profiles 251148, 245946, 239552 and 239399), the Marketing Authorization Application (MAA) for lifitegrast, submitted on 07 August 2017, has been validated by the UK as the Reference Member State involved in the Decentralized Procedure (DCP) MAA was submitted to Denmark, Norway, Sweden, Finland, the UK, Germany, the Netherlands, France, Italy, Portugal, Spain and Greece.

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