- Email: [email protected]
53 Clinical performance of a new multi-purpose disinfecting solution
Abstracts of the 2011 BCLA Annual Clinical Conference / Contact Lens & Anterior Eye 34, Supplement 1 (2011) S1–S43
51
53
Possible origin of adverse solution response to chlorite containing solutions
Clinical performance of a new multi-purpose disinfecting solution
S29
Anisa Mahomed*, Brian J Tighe
Renee J Garofalo*, Leslie D Napier, Jessie M Lemp, Howard A Ketelson, Jerry M Stein, John M Lally
Aston University, Birmingham, UK
Alcon Research Ltd., Fort Worth, TX, USA
*E-mail address: [email protected]
*E-mail address: [email protected]
Purpose: The widespread use of multipurpose solutions (MPSs) has increased the search for novel antibacterial systems. One of these that has achieved recent importance is the chlorite system. In common with many other systems there are specific reports of patient intolerance and these seem to be related to specific patient susceptibility. Since hypochlorite is a potential irritant, a particular focus of the study was to assay levels of hypochlorite and their variability in chlorite containing solutions. Method: Ion chromatography (IC) was used in an attempt to identify potential transient species, such as hypochlorite, that may contribute to discomfort in some patients. A range of chlorinated multipurpose solutions, including Regard, Synergi and AMOPlus, were analysed. Archived samples of previously used tablet formulation, Aerotab and Softab, disinfection systems were analysed for comparative purposes. Results: Several actives (not all of which have yet been identified) were detected with chlorinated disinfection systems. The range of chlorite concentration assayed in the various MPSs varied between 200 and 60ppm. The presence of hypochlorite, although much lower than that of chlorite, was confirmed with peak areas ranging from 0.0045 and 0.05 micro Siemens minutes. Conclusions: Hypochlorite is a common, transient and continually renewed active in chlorinated disinfection systems. Its level in the tears, particularly the posterior tear film will be related to tear borne oxidants and reductants (including superoxidase dismutase, nitric oxide, lactoferrin and cysteine) which may help to explain patient dependence symptoms of transient discomfort.
Purpose: To assess a new multi-purpose disinfecting solution (MPDS) in silicone hydrogel and traditional hydrogel contact lens wearers. Method: Five-hundred and seventy-three subjects at 30 US sites wearing one of six lens brands were randomized to either a new solution (Regimen 1; OPTI-FREE® Evermoist™) or a marketed control (Regimen 2; ReNu® fresh™, B+L). Both subject and evaluator were masked for all safety and efficacy measurements assessed on days 0, 7, 30, 60 and 90. Results: Differences favouring Regimen 1 were noted for all subjective evaluations at the end of the study (1 = strongly agree, 5 = strongly disagree) including lens insertion (1.6±0.6 vs. 1.8±0.7) and removal comfort (2.0±0.8 vs. 2.2±1.0); all day comfort (2.0±1.0 vs. 2.3±1.1); lens moisture (1.9±0.8 vs. 2.1±1.0) and freshness (1.8±0.9 vs. 2.0±1.0); gentle on eye (1.5±0.7 vs. 1.7±0.8); and clear vision (2.0±0.9 vs. 2.3±1.1), all p<0.05. At 16 hours of wear, all day comfort and lens moisture scores were maintained (2.0±0.9 and 1.9±0.8) for Regimen 1. Corneal staining severity (0–4 scale) was significantly lower with Regimen 1 (1.0±1.1) compared to Regimen 2 (1.6±1.5, p<0.0001). Less lysozyme was recovered from Group IV lenses cleaned with Regimen 1 (898±303.1μg) than Regimen 2 (1416.1±361.8μg, p<0.0001). No safety issues were identified. Conclusions: Results indicate that a new Alcon MPDS is safe and effective for both the silicone hydrogel and hydrogel lens wearing population.
52 Link between cleaning efficacy and physical properties of multipurpose solutions Gareth M Ross*, Val J Franklin, Brian J Tighe Biomaterials Research Unit CEAC Aston University, Birmingham, UK *E-mail address: [email protected] Purpose: With multipurpose solutions moving further away from simple surfactant cleaners with successive developments, there is a need to measure and predict the role of combined components such as surfactants/polymers/biocides in the removal of proteins and lipids. Method: A range of in vitro techniques have been developed that establish the link between cleaning and physical properties. They include dynamic (DST), static surface tension (ST) and the in vitro spoliation of lenses with a tear model solution containing both proteins and lipids in combination with fluorescence and UV spectroscopy. This allows the cleaning efficacy of solutions to be compared. Results: The static surface tension results show that the commercial multipurpose solutions have ST between 30 40. However, the dynamic surface tensions show not only different values for different solutions but also the way the DST changes with surface age, with solutions with the same surfactant showing measurable variations. In vitro cleaning efficacy testing shows that even if the same surfactant is used the other components present effect the cleaning efficacy. Distilled water gives a relative cleaning efficiency of 20–30% removal whereas the most effective commercial lens products produce values around 80% removal of the deposited tear components. The efficacies vary for individual proteins and lipids dependent on the lens material and deposition profile. Conclusions: The cleaning efficacy of multipurpose solutions can be linked to the individual components included. The surfactant is the dominant force but the other solution components influence and modify the behavior of the surfactant alone and this in-turn affects cleaning efficacy.
54 Evaluation of a novel multipurpose care solution Riikka L Järvinen 1,2, *, Koskinen Kirsi 1 , Holopainen Jarkko 1 , Ahlgren Jari 3 , Parkkali Suvi 4 , Hirviniemi Heidi 1 1 Finnsusp Ltd., Lieto, Finland; 2 Department of Biochemistry and Food Chemistry, University of Turku, Turku, Finland; 3 Raision Näkökulma Ltd., Raisio, Finland; 4 Turku University of Applied Sciences, Turku, Finland
*E-mail address: riikka.jarvinen@utu.fi Purpose: Antimicrobial efficacy, biocompatibility and comfort are crucial factors when introducing new contact lens care solutions. Method: The test solution, Piiloset BioTwin® , contains hyaluronic acid as a moisturizing comfort agent, Twin-EdaXyl® as a cleaning and lubricating agent and, polyhexanide as a disinfectant in borate buffer system with EDTA. Physical properties (pH, osmolality) were measured at room temperature. Antimicrobial efficacy against bacteria and fungi was evaluated according to ISO 14729 methodologies. Qualitative four-step-scales were used to monitor amoebic efficacy and in vitro biocompatibility [modified ISO 109935 test method with human fibrosarcoma cells (HT1080)]. Clinical performance was evaluated by a pilot-scale (5 persons), randomized, double-blind study with SiHy lenses according to a protocol evaluated and approved by the ethics committee of the Hospital District of Southwestern Finland. Results: The solution has pH of 7.4±0.1 and osmolality of 300±5 mOsm/kg. Summed antimicrobial efficacies against bacteria (P.aureginosa, S. aureus, S. marcescens) and fungi (C. albicans, F. Solani) were >9.0 Log and >2.0 Log units, respectively. Amoebic activity (A. castellanii) was rated good (scale from total kill to no effect) and in vitro biocompatibility non-cytotoxic (scale from non-cytotoxic to strongly cytotoxic). Clinical evaluation showed no solution induced corneal staining, adverse effects or discomfort. Conclusions: The solution has pH and osmolality values similar to human tears. It meets the requirements of the applicable international ISO standards for disinfecting contact lens care solutions. It exhibits good efficacy against A. castellanii and is non-cytotoxic. In pilot-scale clinical study, 4 of 5 persons rated this solution equal or better to their previous care system.
51
53
Possible origin of adverse solution response to chlorite containing solutions
Clinical performance of a new multi-purpose disinfecting solution
S29
Anisa Mahomed*, Brian J Tighe
Renee J Garofalo*, Leslie D Napier, Jessie M Lemp, Howard A Ketelson, Jerry M Stein, John M Lally
Aston University, Birmingham, UK
Alcon Research Ltd., Fort Worth, TX, USA
*E-mail address: [email protected]
*E-mail address: [email protected]
Purpose: The widespread use of multipurpose solutions (MPSs) has increased the search for novel antibacterial systems. One of these that has achieved recent importance is the chlorite system. In common with many other systems there are specific reports of patient intolerance and these seem to be related to specific patient susceptibility. Since hypochlorite is a potential irritant, a particular focus of the study was to assay levels of hypochlorite and their variability in chlorite containing solutions. Method: Ion chromatography (IC) was used in an attempt to identify potential transient species, such as hypochlorite, that may contribute to discomfort in some patients. A range of chlorinated multipurpose solutions, including Regard, Synergi and AMOPlus, were analysed. Archived samples of previously used tablet formulation, Aerotab and Softab, disinfection systems were analysed for comparative purposes. Results: Several actives (not all of which have yet been identified) were detected with chlorinated disinfection systems. The range of chlorite concentration assayed in the various MPSs varied between 200 and 60ppm. The presence of hypochlorite, although much lower than that of chlorite, was confirmed with peak areas ranging from 0.0045 and 0.05 micro Siemens minutes. Conclusions: Hypochlorite is a common, transient and continually renewed active in chlorinated disinfection systems. Its level in the tears, particularly the posterior tear film will be related to tear borne oxidants and reductants (including superoxidase dismutase, nitric oxide, lactoferrin and cysteine) which may help to explain patient dependence symptoms of transient discomfort.
Purpose: To assess a new multi-purpose disinfecting solution (MPDS) in silicone hydrogel and traditional hydrogel contact lens wearers. Method: Five-hundred and seventy-three subjects at 30 US sites wearing one of six lens brands were randomized to either a new solution (Regimen 1; OPTI-FREE® Evermoist™) or a marketed control (Regimen 2; ReNu® fresh™, B+L). Both subject and evaluator were masked for all safety and efficacy measurements assessed on days 0, 7, 30, 60 and 90. Results: Differences favouring Regimen 1 were noted for all subjective evaluations at the end of the study (1 = strongly agree, 5 = strongly disagree) including lens insertion (1.6±0.6 vs. 1.8±0.7) and removal comfort (2.0±0.8 vs. 2.2±1.0); all day comfort (2.0±1.0 vs. 2.3±1.1); lens moisture (1.9±0.8 vs. 2.1±1.0) and freshness (1.8±0.9 vs. 2.0±1.0); gentle on eye (1.5±0.7 vs. 1.7±0.8); and clear vision (2.0±0.9 vs. 2.3±1.1), all p<0.05. At 16 hours of wear, all day comfort and lens moisture scores were maintained (2.0±0.9 and 1.9±0.8) for Regimen 1. Corneal staining severity (0–4 scale) was significantly lower with Regimen 1 (1.0±1.1) compared to Regimen 2 (1.6±1.5, p<0.0001). Less lysozyme was recovered from Group IV lenses cleaned with Regimen 1 (898±303.1μg) than Regimen 2 (1416.1±361.8μg, p<0.0001). No safety issues were identified. Conclusions: Results indicate that a new Alcon MPDS is safe and effective for both the silicone hydrogel and hydrogel lens wearing population.
52 Link between cleaning efficacy and physical properties of multipurpose solutions Gareth M Ross*, Val J Franklin, Brian J Tighe Biomaterials Research Unit CEAC Aston University, Birmingham, UK *E-mail address: [email protected] Purpose: With multipurpose solutions moving further away from simple surfactant cleaners with successive developments, there is a need to measure and predict the role of combined components such as surfactants/polymers/biocides in the removal of proteins and lipids. Method: A range of in vitro techniques have been developed that establish the link between cleaning and physical properties. They include dynamic (DST), static surface tension (ST) and the in vitro spoliation of lenses with a tear model solution containing both proteins and lipids in combination with fluorescence and UV spectroscopy. This allows the cleaning efficacy of solutions to be compared. Results: The static surface tension results show that the commercial multipurpose solutions have ST between 30 40. However, the dynamic surface tensions show not only different values for different solutions but also the way the DST changes with surface age, with solutions with the same surfactant showing measurable variations. In vitro cleaning efficacy testing shows that even if the same surfactant is used the other components present effect the cleaning efficacy. Distilled water gives a relative cleaning efficiency of 20–30% removal whereas the most effective commercial lens products produce values around 80% removal of the deposited tear components. The efficacies vary for individual proteins and lipids dependent on the lens material and deposition profile. Conclusions: The cleaning efficacy of multipurpose solutions can be linked to the individual components included. The surfactant is the dominant force but the other solution components influence and modify the behavior of the surfactant alone and this in-turn affects cleaning efficacy.
54 Evaluation of a novel multipurpose care solution Riikka L Järvinen 1,2, *, Koskinen Kirsi 1 , Holopainen Jarkko 1 , Ahlgren Jari 3 , Parkkali Suvi 4 , Hirviniemi Heidi 1 1 Finnsusp Ltd., Lieto, Finland; 2 Department of Biochemistry and Food Chemistry, University of Turku, Turku, Finland; 3 Raision Näkökulma Ltd., Raisio, Finland; 4 Turku University of Applied Sciences, Turku, Finland
*E-mail address: riikka.jarvinen@utu.fi Purpose: Antimicrobial efficacy, biocompatibility and comfort are crucial factors when introducing new contact lens care solutions. Method: The test solution, Piiloset BioTwin® , contains hyaluronic acid as a moisturizing comfort agent, Twin-EdaXyl® as a cleaning and lubricating agent and, polyhexanide as a disinfectant in borate buffer system with EDTA. Physical properties (pH, osmolality) were measured at room temperature. Antimicrobial efficacy against bacteria and fungi was evaluated according to ISO 14729 methodologies. Qualitative four-step-scales were used to monitor amoebic efficacy and in vitro biocompatibility [modified ISO 109935 test method with human fibrosarcoma cells (HT1080)]. Clinical performance was evaluated by a pilot-scale (5 persons), randomized, double-blind study with SiHy lenses according to a protocol evaluated and approved by the ethics committee of the Hospital District of Southwestern Finland. Results: The solution has pH of 7.4±0.1 and osmolality of 300±5 mOsm/kg. Summed antimicrobial efficacies against bacteria (P.aureginosa, S. aureus, S. marcescens) and fungi (C. albicans, F. Solani) were >9.0 Log and >2.0 Log units, respectively. Amoebic activity (A. castellanii) was rated good (scale from total kill to no effect) and in vitro biocompatibility non-cytotoxic (scale from non-cytotoxic to strongly cytotoxic). Clinical evaluation showed no solution induced corneal staining, adverse effects or discomfort. Conclusions: The solution has pH and osmolality values similar to human tears. It meets the requirements of the applicable international ISO standards for disinfecting contact lens care solutions. It exhibits good efficacy against A. castellanii and is non-cytotoxic. In pilot-scale clinical study, 4 of 5 persons rated this solution equal or better to their previous care system.