Can I read The Orphan Drug for Acanthamoeba Keratitis (ODAK) Trial on EtoBox?
The Orphan Drug for Acanthamoeba Keratitis (ODAK) Trial by John K.G. Dart; Vincenzo Papa; Paolo Rama; Karl Anders Knutsson; Saj Ahmad; Scott Hau; Sara Sanchez; Antonella Franch; Federica Birattari; Pia Leon; Adriano Fasolo; Ewa Mrukwa Kominek; Katarzyna Jadczyk-Sorek; Fiona Carley; Parwez Hossain; Darwin C. Minassian is a Medicine article available to read on EtoBox.
What is The Orphan Drug for Acanthamoeba Keratitis (ODAK) Trial about?
To compare topical PHMB (polihexanide) 0.02% (0.2 mg/ml)þ propamidine 0.1% (1 mg/ml) with PHMB 0.08% (0.8 mg/ml)þ placebo (PHMB 0.08%) for Acanthamoeba keratitis (AK) treatment. Design: Prospective, randomized, double-masked, active-controlled, multicenter phase 3 study (Clinical-Trials.gov identifier, NCT03274895). Participants: One hundred thirty-five patients treated at 6 European centers. Methods: Principal inclusion criteria were 12 years of age or older and in vivo confocal microscopy with clinical findings consistent with AK. Also included were participants with concurrent bacterial keratitis who were using topical steroids and antiviral and antifungal drugs before randomization. Principal exclusion criteria were concurrent herpes or fungal keratitis and use of antiamebic therapy (AAT). Patients were randomized 1:1 using a computer-generated block size of 4. This was a superiority trial having a predefined noninferiority margin. The sample size of 130 participants gave approximately 80% power to detect 20-percentage point superiority for PHMB 0.08% for the primary outcome of the medical cure rate (MCR; without surgery or change of AAT) within 12 months, cure defined by clini
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- Author
- John K.G. Dart; Vincenzo Papa; Paolo Rama; Karl Anders Knutsson; Saj Ahmad; Scott Hau; Sara Sanchez; Antonella Franch; Federica Birattari; Pia Leon; Adriano Fasolo; Ewa Mrukwa Kominek; Katarzyna Jadczyk-Sorek; Fiona Carley; Parwez Hossain; Darwin C. Minassian
- Publisher
- Elsevier BV
- Published
- 2024
- Language
- EN
- Field
- Medicine (Health Sciences)