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.
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
- 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