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A Phase II/III, Randomized, Double-Masked, Vehicle-Controlled, Efficacy, Safety and Tolerability Study of Chloroprocaine 3% Gel Eye Drops in Healthy Volunteers

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Trial Profile

A Phase II/III, Randomized, Double-Masked, Vehicle-Controlled, Efficacy, Safety and Tolerability Study of Chloroprocaine 3% Gel Eye Drops in Healthy Volunteers

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 29 Sep 2022

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At a glance

  • Drugs Chloroprocaine (Primary)
  • Indications Regional anaesthesia
  • Focus Registrational; Therapeutic Use
  • Sponsors Sintetica

    • Most Recent Events

    • 27 Sep 2022 According to a Harrow Health media release, the U.S. Food and Drug Administration (FDA) has approved IHEEZO (chloroprocaine hydrochloride ophthalmic gel) 3% for ocular surface anesthesia, based on results from NCT04753710, NCT04685538 and NCT04779606.
    • 10 Feb 2021 Status changed from recruiting to completed.
    • 22 Sep 2020 New trial record

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