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A Randomized, Multicenter, Double-Masked, Vehicle-Controlled Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca

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Trial Profile

A Randomized, Multicenter, Double-Masked, Vehicle-Controlled Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 18 Nov 2021

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At a glance

  • Drugs Ciclosporin (Primary)
  • Indications Dry eyes; Keratoconjunctivitis sicca
  • Focus Registrational; Therapeutic Use
  • Acronyms Emerald
  • Sponsors Ocular Technologies; Sun Pharma Global FZE; Sun Pharmaceutical Industries

    • Most Recent Events

    • 14 Oct 2019 Results published in the Sun Pharmaceutical Industries Media Release
    • 16 Aug 2018 According to a Sun Pharmaceutical media release, the US FDA has approved OTX-101 (cyclosporine A, ophthalmic solution) 0.09% to treat dry eye disease.
    • 27 Dec 2017 According to a Sun Pharmaceutical media release, the US FDA has accepted a New Drug Application (NDA) for OTX-101 (cyclosporine A, ophthalmic solution) 0.09%.
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