| Summary: | Purpose: Antimicrobial, cytotoxicity and clinical performance of a new soft contact lens multi-purpose solution (COMPLETE® RevitaLens) based on polyquaternium-1 and alexidine dihydrochloride (NuMPS) was evaluated.
Methods: Antimicrobial efficacy was assessed according to ISO 14729 for both biocidal and regimen performance against bacteria and fungi. Acanthamoeba efficacy was tested along with ability to retain antimicrobial activity on partial evaporation. In vitro cytotoxicity of NuMPS and OPTI-FREE® RepleniSH® MPS (MPS-3) was assessed based on ISO 10993-5 and United States Pharmacopeia (USP) methods. In addition, a 3 month, double-masked, parallel group clinical trial comparing safety and acceptability with respect to MPS-3 was conducted with 4 silicone hydrogel (SiHy) and FDA Group IV lens types.
Results: NuMPS showed broad antimicrobial efficacy, including Acanthamoeba, giving a 3–4 log10 reduction in viability after 6 hours contact time. NuMPS also passed ISO 14729 regimens with SiHy and etafilcon lenses for bacteria, fungi and also Acanthamoeba. The cytotoxicity of NuMPS was equivalent or better compared to MPS-3. In the clinical trial, there was no statistically significant between-group difference in corneal staining (p > 0.05). Patients using MPS-3 had more adverse events than patients using NuMPS: 11.8 % (11/93) versus 2.8 % (5/177), respectively, (p < 0.05). There were no differences noted in cleanliness or wearing comfort (p > 0.05).
Conclusion: Taken together, the results of these studies indicate that the NuMPS is a novel and effective soft contact lens care solution.
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