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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 27 Aug 2024

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At a glance

  • Drugs Polihexanide (Primary) ; Propamidine
  • Indications Acanthamoeba infections; Keratitis
  • Focus Registrational; Therapeutic Use
  • Acronyms ODAK; ODAK Phase 3 (043/SI)
  • Sponsors SIFI

    • Most Recent Events

    • 26 Aug 2024 According to a SIFI media release, company announced the European Commission has approved AKANTIOR (polihexanide) for the treatment of acanthamoeba keratitis (AK) in adults and children from 12 years of age
    • 22 Jul 2024 According to a SIFI media release, EC decision is expected in August 2024.
    • 31 May 2024 According to a SIFI media release, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of AKANTIOR (polihexanide under the international non-proprietary name), for the treatment of acanthamoeba keratitis, a rare ophthalmic disease.

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