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A 4-week, Phase III, Multicenter, Double-masked, Vehicle-controlled Clinical Study to Evaluate Safety and Efficacy of Oxervate® (Cenegermin) 20 mcg/mL Ophthalmic Solution Versus Vehicle, in Patients With Severe Sjogren's Dry Eye Disease (PROTEGO-1 Study)

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Trial Profile

A 4-week, Phase III, Multicenter, Double-masked, Vehicle-controlled Clinical Study to Evaluate Safety and Efficacy of Oxervate® (Cenegermin) 20 mcg/mL Ophthalmic Solution Versus Vehicle, in Patients With Severe Sjogren's Dry Eye Disease (PROTEGO-1 Study)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Jun 2024

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At a glance

  • Drugs Cenegermin (Primary)
  • Indications Dry eyes; Sjogren's syndrome
  • Focus Registrational; Therapeutic Use
  • Acronyms NGF0121
  • Sponsors Dompe Farmaceutici
  • Most Recent Events

    • 06 Sep 2023 This trial has been completed in Italy According to European Clinical Trials Database record
    • 01 Jun 2023 Planned End Date changed from 1 May 2023 to 31 Jul 2023.
    • 24 Oct 2022 Planned End Date changed from 1 Jan 2023 to 1 May 2023.

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