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Randomized, Assessor-Masked, Active-Controlled, Phase 3 Study to Evaluate Efficacy, Safety and Tolerability of 0.08% Polyhexamethylene Biguanide (PHMB) Ophthalmic Solution in Comparison with 0.02% PHMB + 0.1% Propamidine Combination Therapy in Subjects Affected by Acanthamoeba keratitis.

Trial Profile

Randomized, Assessor-Masked, Active-Controlled, Phase 3 Study to Evaluate Efficacy, Safety and Tolerability of 0.08% Polyhexamethylene Biguanide (PHMB) Ophthalmic Solution in Comparison with 0.02% PHMB + 0.1% Propamidine Combination Therapy in Subjects Affected by Acanthamoeba keratitis.

Recruiting
Phase of Trial: Phase III

Latest Information Update: 09 Nov 2018

At a glance

  • Drugs Polihexanide (Primary) ; Propamidine
  • Indications Acanthamoeba infections; Keratitis
  • Focus Registrational; Therapeutic Use
  • Sponsors SIFI
  • Most Recent Events

    • 27 Aug 2018 Planned End Date changed from 30 Jun 2019 to 30 Jun 2020.
    • 27 Aug 2018 Planned primary completion date changed from 31 Dec 2018 to 31 Dec 2019.
    • 21 Jul 2017 New trial record
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