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Phase 1 multiple-dose safety study of preservative-free PHMB ophthalmic solution in healthy subjects
NL-OMON42469Phase 1Active, not recruiting
- Sponsor
- SIFI SpA
- Start
- Nov 2015
- Modality
- Small Molecules, Biodegradable Polymers → Polymer-based Nanoparticles → Nanoparticles → Drug Delivery Systems
- Countries
- 1
01
Overview
Phase 1, randomised, double-blind trial of polihexanide in Acanthamoeba keratitis (AK) (4 arms), sponsored by SIFI SpA. Primary endpoints: Ocular safety and tolerability of preservative-free PHMB at three concentrations and Systemic safety of preservative-free PHMB. Started Nov 2015; status: active, not recruiting.
02
Drugs
polihexanide
03
Conditions
Acanthamoeba keratitis (AK)
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