Abstract

BackgroundContact lens-related infections are often associated with inadequate contact lens hygiene, and therefore, contact lens care products should be able to sufficiently minimise the amount of pathogens that are responsible for these infections. In 2001, the EN ISO 14729 was introduced to ensure adequate disinfection efficacy of contact lens care solutions, but this norm has recently been criticised.MethodsIn this study, six frequently used contact lens care solutions were retested according to the Stand Alone Test of the EN ISO 14729 (2001). The Stand Alone Test is a quantitative suspension test. In addition, the products were tested in a modified setting adding an organic load. The load was a mixture of human blood serum, lysozyme, and mucine, which resembles tear fluid.ResultsThe criteria of the Stand Alone Test recommended in EN ISO 14729 were only met by Aosept Plus. This 3% hydrogen-peroxide-based contact lens care solution attained a reduction factor of > 5 log units for bacteria and > 4 for fungi in all cases. Two further contact lens care solutions, Blue Vision and Optifree Replenish, met the criteria of a reduction factor of > 3 log units for bacteria and > 1 log unit for fungi, but only in the presence of artificial tear fluid. The three remaining products did not exhibit adequate disinfecting efficacy, at least against one of the tested microorganisms.ConclusionsThrough the observation that the artificial tear fluid used in this study influences the disinfecting efficacy of contact lens care solutions, especially that of multi-purpose solutions, in a different way than does albumin, mucine, or even the organic load suggested in EN ISO 14729, it becomes obvious that the test conditions in the EN ISO 14729 should be revised in order to create more realistic conditions, e.g., by using a more realistic artificial tear fluid. Furthermore, we suggest adapting the EN ISO 14729 to the European test hierarchy for chemical disinfectants and antiseptics, which consists of three test phases and also requests meeting stricter criteria in order to pass the test. Unless the test conditions guarantee a sufficient reduction of potential pathogens, the risk of contact lens-related microbial keratitis and other infections will remain for the users.

Highlights

  • Contact lens-related infections are often associated with inadequate contact lens hygiene, and contact lens care products should be able to sufficiently minimise the amount of pathogens that are responsible for these infections

  • The results show that only Aosept Plus met these criteria and even exceeded them with > 6 log units for bacteria and > 4 log units for fungi without organic load (Tables 2 and 5)

  • Through the observation that the artificial tear fluid used in this study influences the disinfecting efficacy of contact lens (CL) care solutions, especially that of multi-purpose solutions (MPSs), in a different way than do albumin, mucine or even the organic load suggested in EN ISO 14729, it becomes obvious that the test conditions in the EN ISO 14729 should be revised to create more realistic conditions, e.g., by using a more realistic artificial tear fluid

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Summary

Introduction

Contact lens-related infections are often associated with inadequate contact lens hygiene, and contact lens care products should be able to sufficiently minimise the amount of pathogens that are responsible for these infections. Different CL care solutions do not even provide a minimum of safety for the wearer and had to be taken off the market as they were associated with CLrelated microbial keratitis [11,38,39,40,41,42,43,44] In addition to these issues, numerous studies have shown that CLs, CL cases and CL care solutions can be loaded with up to 107 colony forming units (CFU) of bacterial, amoebic and even viral pathogens [18,25,45,46]

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