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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)

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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: 14 Mar 2023

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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

    • 01 Feb 2023 Results of an analysis of integrated data (n=602) assessing efficacy outcomes for VNS in patients with mild-moderate and severe dry eye disease from two randomized clinical trials (ONSET-1; NCT03636061) and (ONSET-2; NCT04036292), published in the Optometry and Vision Science.
    • 18 Nov 2022 Results of post hoc subgroup analysis of data integrated from ONSET-1 and ONSET-2, published in the Ophthalmology and Therapy
    • 01 Oct 2022 Primary endpoint (Schirmers Test /Eye Dryness Score (Visual Analogue Scale (VAS)) has been met according to results published in the Cornea

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