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Multicenter, Randomized, Controlled, Double-Masked Clinical Trial to Evaluate the Efficacy of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease (The ONSET-1 Study)

Trial Profile

Multicenter, Randomized, Controlled, Double-Masked Clinical Trial to Evaluate the Efficacy of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease (The ONSET-1 Study)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 04 Dec 2019

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At a glance

  • Drugs Varenicline (Primary)
  • Indications Dry eyes
  • Focus Registrational; Therapeutic Use
  • Acronyms ONSET; ONSET-1
  • Sponsors Oyster Point Pharmaceuticals
  • Most Recent Events

    • 04 Dec 2019 According to an Oyster Point Pharmaceuticals media release, the company itends to submit a 505(b)(2) NDA to the FDA in the second half of 2020, based on the data from this and other two trials (ZEN and ONSET-2).
    • 24 Jul 2019 Results published in the Oyster Point Pharmaceuticals Media Release.
    • 25 Apr 2019 According to an Oyster Point Pharmaceuticals media release, data from this study will be presented at the 2019 American Society for Cataract and Refractive Surgery (ASCRS ASOA) Annual Meeting (6th May 2019).
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