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: 15 Mar 2024
Price :
$35
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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
- 01 Mar 2024 Results comparing the topical PHMB (polihexanide) 0.02% (0.2 mg/ml)+ propamidine 0.1% (1 mg/ml) with PHMB 0.08% (0.8 mg/ml)+ placebo (PHMB 0.08%) for Acanthamoeba keratitis
- 09 Jan 2023 According to a SIFI media release, the company expects a potential positive opinion of the EMA Committee for Medicinal Products (CHMP) for Human Use in 2023.
- 13 Oct 2022 According to a SIFI media release, regulatory approval by the European Commission is expected in mid-2023.