A Phase 2, Multicenter, Randomized, Double-Masked and Placebo-Controlled Study Evaluating the Efficacy of Three Different Concentrations (0.1%, 1.0%, 5.0%) of SAR 1118 Ophthalmic Solution in Subjects With Dry Eye Using the Controlled Adverse Environment (CAE) Model

Trial Profile

A Phase 2, Multicenter, Randomized, Double-Masked and Placebo-Controlled Study Evaluating the Efficacy of Three Different Concentrations (0.1%, 1.0%, 5.0%) of SAR 1118 Ophthalmic Solution in Subjects With Dry Eye Using the Controlled Adverse Environment (CAE) Model

Completed
Phase of Trial: Phase II

Latest Information Update: 09 Mar 2017

At a glance

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

    • 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.
    • 04 Feb 2016 According to a Shire media release, the US FDA has acknowledged the receipt of resubmission of NDA for lifitegrast.
    • 25 Jan 2016 According to a Shire media release, the company has resubmitted the NDA to the US FDA for lifitegrast for the treatment of signs and symptoms of dry eye disease in adults in response to the complete response letter received from the FDA on October 16, 2015. The NDA for lifitegrast now includes data from one Phase 2 study (CT profile 700245926), 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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