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A 4-week,Phase III, Multicenter, Double-masked, Vehicle-controlled Clinical Study to Evaluate Safety and Efficacy of Cenegermin (Oxervate®) 20 mcg/mL Ophthalmic Solution Versus Vehicle, in Patients With Severe Sjogren's Dry Eye Disease Under Treatment With Cyclosporine A (PROTEGO-2 Study)

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A 4-week,Phase III, Multicenter, Double-masked, Vehicle-controlled Clinical Study to Evaluate Safety and Efficacy of Cenegermin (Oxervate®) 20 mcg/mL Ophthalmic Solution Versus Vehicle, in Patients With Severe Sjogren's Dry Eye Disease Under Treatment With Cyclosporine A (PROTEGO-2 Study)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Dec 2024

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At a glance

  • Drugs Cenegermin (Primary)
  • Indications Dry eyes; Keratoconjunctivitis sicca; Sjogren's syndrome
  • Focus Registrational; Therapeutic Use
  • Acronyms NGF0221; PROTEGO-2
  • Sponsors Dompe Farmaceutici

    • Most Recent Events

    • 21 Dec 2023 Status changed from active, no longer recruiting to completed.
    • 01 Feb 2023 Status changed from recruiting to active, no longer recruiting.
    • 24 Oct 2022 Planned number of patients changed from 48 to 80.

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