04Nov 2023
The Orphan Drug for Acanthamoeba Keratitis (ODAK) trial

The Orphan Drug for Acanthamoeba Keratitis (ODAK) trial

This Phase 3, randomized, double-masked study compared the efficacy of topical PHMB 0.02% + propamidine to PHMB 0.08% with placebo for treating Acanthamoeba keratitis (AK). The trial included 135 participants across six European centers. The primary outcome, the medical cure rate at 12 months, was 86.6% for PHMB 0.02% + propamidine and 86.7% for PHMB 0.08%, meeting non-inferiority criteria. Secondary outcomes, including visual acuity and treatment failure rates, were similar between treatments. No serious drug-related adverse events occurred.

  • #ophthalmology

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