A Phase 3, Multicenter, Randomized, Double-masked, and Placebo-controlled Study Evaluating the Efficacy and Safety of a 5.0% Concentration of Lifitegrast Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Disease and History of Recent Artificial Tear Use

Trial Profile

A Phase 3, Multicenter, Randomized, Double-masked, and Placebo-controlled Study Evaluating the Efficacy and Safety of a 5.0% Concentration of Lifitegrast Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Disease and History of Recent Artificial Tear Use

Completed
Phase of Trial: Phase III

Latest Information Update: 17 Jun 2017

At a glance

  • Drugs Lifitegrast (Primary)
  • Indications Dry eyes
  • Focus Registrational; Therapeutic Use
  • Acronyms OPUS-3
  • Sponsors Shire
  • Most Recent Events

    • 17 Jun 2017 Results evaluating the combined evidence from 5 clinical trials of lifitegrast ophthalmic solution 5.0% (LIF) in subjects with dry eye disease presented at the 18th Annual Congress of the European League Against Rheumatism
    • 14 Feb 2017 According to a Shire Pharma media release, company has filed a New Drug Submission (NDS) with Health Canada for the marketing authorization of lifitegrast for the treatment of dry eye disease in adults in Canada.
    • 12 Jul 2016 According to a US FDA media release, the FDA approved lifitegrast for the treatment of signs and symptoms of dry eye disease in adults based on data from three Phase 3 efficacy and safety studies (OPUS-1, OPUS-2 and OPUS-3), and one long-term (one-year) Phase 3 safety study (SONATA).
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