RESUMEN
CLINICAL RELEVANCE: Symbols are commonly used to represent information of health care products included multipurpose solutions (MPSs) for contact lens (CL) care. BACKGROUND: Little knowledge is available about recognition and comprehension by regular soft CL wearers of commonly used symbols in the instructions of CL MPSs marketed worldwide. METHODS: CL wearers from the UK and Spain were invited to answer an anonymous on-line questionnaire (distributed though Facebook and Twitter) concerning the recognition and comprehension of seven common symbols (ISO 15223:2017 and EN 980:2008) included in MPS package instructions. RESULTS: Answers of one hundred-ten soft CL wearers who use MPS (27 in the UK and 83 in Spain) were analysed showing low recognition and comprehension of the surveyed symbols even in wearers with > 5 years of CL wear (71.8%). The CE marked was the most recognised (96% in the UK and 88% in Spain, P = 0.29) and understood (78% in the UK and 85% in Spain, P = 0.25) symbol, but other important symbols, such as 'Caution' and 'Do not reuse', were under recognised (22% in the UK and 19% in Spain, P = 0.78 and 11% in the UK and 6% in Spain, P = 0.40 respectively) and understood (close to 30% in both countries P > 0.15). Participants with > 5 years of experience, showed slightly higher comprehension (P < 0.05) in some symbols ('Sterilised'; 'Do not reuse'; 'Use by date' and 'CE marked'). CONCLUSION: These results suggest an insufficient comprehension of seven common symbols included in MPS instructions among regular CL wearers in the UK and Spain without high impact of CL wear experience. Improving the education and symbol comprehension of regular CL wearers could help to get better patients' behaviour and safe use of MPS in soft CLs care.
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Comprensión , Lentes de Contacto Hidrofílicos , Soluciones para Lentes de Contacto , Atención a la Salud , Humanos , Encuestas y CuestionariosRESUMEN
Abstract Introduction: Multipurpose solutions (MPS) for soft contact lenses (SCL) play an essential role in inhibiting potentially pathogenic agents. Their antimicrobial effectiveness is assessed in vitro and their safety in vivo, with clinical trials that include a combination of different solutions and lens materials. The objective is to assess the biocompatibility of a new SCL MPS produced in Colombia that contains polyhexamethylene biguanide (PHMB) and to determine its antimicrobial activity. Materials and Methods: This was a crossover study with 25 subjects who did not wear lens and who were fitted with different combinations of five SCL materials with either MPS or control physiological saline solution (CS). Corneal thickness, conjunctival hyperemia, corneal staining, and comfort were assessed after two hours of wearing SCL. Antimicrobial effectiveness was measured using ISO 14729 standard assays. Results: When considering SCL material, there was a statistically significant difference between the new MPS and the CS for Comfilcon A (p < 0.05). There was no statistical or clinically significant difference for corneal thickness or corneal staining between the combination of lens material and new MPS with the CS (p > 0.05). After two hours of lens insertion, comfort scores were higher than 7.8. The MPS reduced bacteria colony forming units (CFU) in over 3 log, and fungal CFU in over 1.0 log. Conclusions: The new MPS met the antimicrobial standards of ISO 14729, is considered safe and biocompatible with the ocular surface and retains high comfort levels.
Resumen Introducción: las soluciones multipropósito (SMP) para lentes de contacto blandos (LCB) desempeñan un papel esencial en la inhibición de agentes potencialmente patógenos. Su efectividad antimicrobiana se evalúa in vitro, y su seguridad, in vivo, con ensayos clínicos que incluyen una combinación de diferentes soluciones y materiales para lentes. El objetivo es evaluar la biocompatibilidad de una nueva SMP producida en Colombia que contiene polihexametileno biguanida (PHMB) y determinar su actividad antimicrobiana. Materiales y métodos: estudio cruzado con 25 sujetos no usuarios de lentes, que fueron adaptados con cinco combinaciones diferentes de materiales de LCB con una nueva SMP o solución salina fisiológica de control (CS). El grosor corneal, la hiperemia conjuntival, la tinción corneal y la comodidad se evaluaron después de dos horas de uso del LC. La efectividad antimicrobiana se midió utilizando ensayos estándar ISO 14729. Resultados: considerando el material del LCB, solo hubo una diferencia estadísticamente significativa entre la nueva SMP y el CS para el Comfilcon A (p < 0.05). Tampoco hubo diferencias estadísticamente o clínicamente significativas para el grosor corneal o la tinción corneal, entre la combinación del material del lente y la nueva SMP con el CS (p > 0.05). Después de dos horas de uso del lente, las puntuaciones de confort fueron superiores a 7.8. La SMP redujo las unidades formadoras de colonias (UFC) de bacterias en más de 3 log, y las UFC fúngicas en más de 1.0 log. Conclusiones: la nueva SMP cumplió con los estándares antimicrobianos de ISO 14729, y se considera segura y biocompatible con la superficie ocular, con altos niveles de confort.
Resumo Introdução: as soluções multipropósito (SMP) para lentes de contato macias (LCM) apresentam um papel essencial na inibição de agentes potencialmente patógenos. Sua eficácia como agente antimicrobiano se valia in vitro, e sua segurança, in vivo, como ensaios clínicos que incluem uma combinação de diferentes soluções e materiais para lentes. O objetivo é avaliar a biocompatibilidade de uma nova SMP produzida na Colômbia a base de polihexametileno biguanida (PHMB) e determinar seu potencial antimicrobiano. Materiais e métodos: estudo cruzado com 25 indivíduos não usuários de lentes, que foram adaptados com cinco combinações diferentes de LCM como uma nova SMP ou solução salina fisiológica como controle (CS). A espessura da córnea, a hiperemia conjuntival, a coloração da córnea e a comodidade, foram avaliadas após duas horas de uso da LCB. A eficácia antimicrobiana foi medida com ensaios padrão ISO 14729. Resultados: considerando o material da LCB, houve apenas uma diferença estatisticamente significativa entre a nova SMP e o CS, paro o Comfilcon A (p <0.05). Não houve diferença estatisticamente ou clinicamente significativa para a espessura da córnea ou a coloração da córnea, entre a combinação do material da lente e a nova SMP com o controle CS (p > 0.05). Após duas horas de uso, as pontuações de conforto foram superiores a 7,8. A SMP reduziu as unidades formadoras de colônias (UFC) de bactérias em mais de 3 log, e as UFC fúngicas em mais de 1.0 log. Conclusões: a nova SMP cumpriu com os padrões antimicrobianos ISO 14729, é considerada segura e biocompatível com a superfície ocular, com altos níveis de conforto.
Asunto(s)
Humanos , Lentes de Contacto Hidrofílicos , Hiperemia , Células MadreRESUMEN
Multiple use contact lenses have to be disinfected overnight to reduce the risk of infections. However, several studies demonstrated that not only microorganisms are affected by the disinfectants, but also ocular epithelial cells, which come into contact via residuals at reinsertion of the lens. Visible light has been demonstrated to achieve an inactivation effect on several bacterial and fungal species. Combinations with other disinfection methods often showed better results compared to separately applied methods. We therefore investigated contact lens disinfection solutions combined with 405 nm irradiation, with the intention to reduce the disinfectant concentration of ReNu Multiplus, OptiFree Express or AOSept while maintaining adequate disinfection results due to combination benefits. Pseudomonads, staphylococci and E. coli were studied with disk diffusion assay, colony forming unit (cfu) determination and growth delay. A log reduction of 4.49 was achieved for P. fluorescens in 2 h for 40% ReNu Multiplus combined with an irradiation intensity of 20 mW/cm2 at 405 nm. For AOSept the combination effect was so strong that 5% of AOSept in combination with light exhibited the same result as 100% AOSept alone. Combination of disinfectants with visible violet light is therefore considered a promising approach, as a reduction of potentially toxic ingredients can be achieved.
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Lentes de Contacto , Desinfectantes , Desinfección , Luz , Recuento de Colonia Microbiana , Escherichia coliRESUMEN
Interactions between contact lens multipurpose solution (MPS) components and the contact lenses with which they are used are both lens and solution dependent. As such, lens dimensional changes may arise after cleaning and immersion cycling in different lens care solutions over different time courses. In this study, the dimensional stability of five planned-replacement silicone hydrogel lenses (lotrafilcon B, comfilcon A, senofilcon A, senofilcon C, and samfilcon A) over 30 cycles in three different MPSs (Biotrue, OPTI-FREE Express, and OPTI-FREE Puremoist) was evaluated. Measurements of diameter, sagittal depth, power, roundness, and center thickness were obtained prior to, during, and after 30 cycles of cleaning and storage. Diameters of all lenses increased when soaked in Express or Biotrue but held the International Standards Organization (ISO) tolerance over the full course of 30 disinfection cycles; however, the diameters of comfilcon A, senofilcon A, senofilcon C, and samfilcon A lenses soaked in Puremoist exceeded ISO tolerance after between 4 and 9 immersion cycles. In contrast, the diameter of lotrafilcon B held tolerance. Similarly, all lenses cycled in Express or Biotrue held tolerance for sagittal depth, while in Puremoist only lotrafilcon B held tolerance. All lenses became less round in all MPSs but held tolerance for both power and central thickness. Given the lack of reported clinical issues with Puremoist when used with lenses other than lotrafilcon B, we propose that it may be appropriate to revisit the ISO test methods and tolerances to determine if they are still applicable for silicone hydrogel lenses.
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Soluciones para Lentes de Contacto/farmacología , Lentes de Contacto , Hidrogeles/química , Siliconas/química , Antiinfecciosos/farmacología , Desinfección , Contaminación de Equipos , Humanos , Ensayo de MaterialesRESUMEN
PURPOSE: To compare the biocompatibility and subjective symptoms of four multipurpose solutions marketed in Palestine with hydrogel contact lenses. METHODS: 50 habitual soft contact lens wearers were recruited in this interventional crossover study. Subjects were asked to attend the optometry clinic five times. A new pair of hydrogel lenses (Bioxifilcon-B) were fitted each time. This pair was soaked randomly overnight in one of the following four-multipurpose solutions (NEOPLUS®, AvizorUnicaSensitive®, ReNuMultiPlus® and COMPLETERevitaLens®) which contain different disinfecting agents (PHMB, Phx, PAPB, and PQ-1+Alexidine, respectively), or non-preserved saline. At each visit, corneal staining, ocular redness and subjective symptoms were assessed. RESULTS: The percentage of corneal staining increased significantly (P≤0.050) after soaking the lenses with PHMB (86%), PAPB (64%) and Phx (32%) based-solutions. However, a non-significant increase was noticed after the use of PQ-1+Alexidine based solution (30%, P=0.083). Ocular redness evaluation showed a significant increase (P≤0.050) in limbal hyperemia after the use of all solutions, while bulbar redness was significantly increased after the use of biguanide-based solutions (P≤0.050). The subjective assessment analysis showed a non-significant change in comfort, dryness, photophobia and scratchiness (P≥0.050) at 2-h intervention using all solutions, except for the PHMB based solution which showed a significant change in subjective symptoms (P≤0.050). CONCLUSION: The combination of Bioxifilcon-B hydrogel contact lenses and solution containing PHMB, PAPB and Phx-disinfectants induced a significant increase in corneal staining after 2h of CL-wear with a higher severity when the PHMB-based solution was used, while the PQ-1+Alexidine-based solution did not. Only the PHMB-based solution triggered a significant change in subjective symptoms which might which suggests that it might be related to the severity of staining rather than the induction of staining.
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Enfermedades de la Conjuntiva/inducido químicamente , Soluciones para Lentes de Contacto/efectos adversos , Lentes de Contacto Hidrofílicos , Enfermedades de la Córnea/inducido químicamente , Síndromes de Ojo Seco/inducido químicamente , Hiperemia/inducido químicamente , Fotofobia/inducido químicamente , Adolescente , Adulto , Enfermedades de la Conjuntiva/diagnóstico , Enfermedades de la Córnea/diagnóstico , Estudios Cruzados , Síndromes de Ojo Seco/diagnóstico , Femenino , Humanos , Hiperemia/diagnóstico , Masculino , Ensayo de Materiales , Fotofobia/diagnóstico , Adulto JovenRESUMEN
BACKGROUND: This study aimed to evaluate the adhesion of Acanthamoeba trophozoites on cosmetic contact lenses (CLs) with and without CL care multipurpose solution (MPS) treatment. METHODS: Acanthamoeba lugdunensis L3a trophozoites were inoculated onto disks trimmed from CLs: 1-day Acuvue moist, 1-day Acuvue define, Acuvue 2, and Acuvue 2 define. After 18-hour inoculation, the number of adherent trophozoites was counted under phase contrast microscopy. The effects of MPS, Opti-Free Express, soaking CLs for 6 hours, on Acanthamoeba adhesion were analyzed. Scanning electron microscopic examination was performed for assessment of Acanthamoeba attached on the lens surface. RESULTS: Acanthamoeba trophozoites showed greater adhesion to cosmetic CL (P = 0.017 for 1-day CL and P = 0.009 for 2-week CL) although there was no significant difference between the types of cosmetic CL. On all lenses, the number of adherent Acanthamoeba was significantly reduced after treatment with MPS (P < 0.001 for 1-day Acuvue moist, P = 0.046 for 1-day Acuvue define, P < 0.001 for Acuvue 2, and P = 0.015 for Acuvue 2 define), but there was still significant difference between conventional and cosmetic CLs (P = 0.003 for 1-day CL and P < 0.001 for 2-week CL, respectively). More attachment of Acanthamoeba was observed on colored area and the acanthopodia of Acanthamoeba was placed on the rough surface of colored area. CONCLUSION: Acanthamoeba showed a greater affinity for cosmetic CL and mostly attached on colored area. Although MPS that contained myristamidopropyl dimethylamine reduced the adhesion rate, there was a significant difference between conventional and cosmetic CLs.
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Acanthamoeba/fisiología , Lentes de Contacto/parasitología , Desinfectantes/farmacología , Humanos , Microscopía Electrónica de Rastreo , Trofozoítos/efectos de los fármacos , Trofozoítos/fisiologíaRESUMEN
BACKGROUND: This study aimed to evaluate the adhesion of Acanthamoeba trophozoites on cosmetic contact lenses (CLs) with and without CL care multipurpose solution (MPS) treatment. METHODS: Acanthamoeba lugdunensis L3a trophozoites were inoculated onto disks trimmed from CLs: 1-day Acuvue moist, 1-day Acuvue define, Acuvue 2, and Acuvue 2 define. After 18-hour inoculation, the number of adherent trophozoites was counted under phase contrast microscopy. The effects of MPS, Opti-Free Express, soaking CLs for 6 hours, on Acanthamoeba adhesion were analyzed. Scanning electron microscopic examination was performed for assessment of Acanthamoeba attached on the lens surface. RESULTS: Acanthamoeba trophozoites showed greater adhesion to cosmetic CL (P = 0.017 for 1-day CL and P = 0.009 for 2-week CL) although there was no significant difference between the types of cosmetic CL. On all lenses, the number of adherent Acanthamoeba was significantly reduced after treatment with MPS (P < 0.001 for 1-day Acuvue moist, P = 0.046 for 1-day Acuvue define, P < 0.001 for Acuvue 2, and P = 0.015 for Acuvue 2 define), but there was still significant difference between conventional and cosmetic CLs (P = 0.003 for 1-day CL and P < 0.001 for 2-week CL, respectively). More attachment of Acanthamoeba was observed on colored area and the acanthopodia of Acanthamoeba was placed on the rough surface of colored area. CONCLUSION: Acanthamoeba showed a greater affinity for cosmetic CL and mostly attached on colored area. Although MPS that contained myristamidopropyl dimethylamine reduced the adhesion rate, there was a significant difference between conventional and cosmetic CLs.
Asunto(s)
Acanthamoeba , Lentes de Contacto , Microscopía de Contraste de Fase , TrofozoítosRESUMEN
BACKGROUND: Because corneal infiltrative events (CIEs) may result from bacterial components on contact lenses, which can come from contaminated lens cases, we evaluated the biocidal efficacy of five multipurpose solutions against Gram-negative commonly isolated and CIE-associated organisms. METHODS: Of the multipurpose solutions tested, one contained polyhexamethylene biguanide (PHMB)/polyquaternium-1 (PQ-1; Bausch & Lomb Incorporated: Biotrue), one contained alexidine dihydrochloride (alexidine)/PQ-1 (AMO: RevitaLens OcuTec) and three contained PQ-1/myristamidopropyl dimethylamine (MAPD; Alcon: Opti-Free PureMoist, PQ-1/MAPD-1; Opti-Free RepleniSH, PQ-1/MAPD-2; Opti-Free Express, PQ-1/MAPD-3). Challenge organisms were CIE-associated Achromobacter xylosoxidans, Delftia acidovorans and Stenotrophomonas maltophilia at manufacturer-recommended durations (stand-alone), in lens cases without lenses (up to seven days) and in lens cases with etafilcon A lenses (up to 30 days). RESULTS: In stand-alone testing against CIE-associated organisms, PHMB/PQ-1 and alexidine/PQ-1 were significantly superior versus MAPD-based multipurpose solutions against A. xylosoxidans (all p ≤ 0.01), D. acidovorans (all p ≤ 0.001) and S. maltophilia (all p ≤ 0.05). In lens cases, PHMB/PQ-1 and alexidine/PQ-1 achieved greater than 3-log reductions against all challenge organisms at all times evaluated. PQ-1/MAPD-1 achieved a greater than 3-log reduction against D. acidovorans at 24 hours; PQ-1/MAPD-1 and PQ-1/MAPD-3 achieved greater than 3-log reductions at seven days against all organisms. In lens cases with lenses, PHMB/PQ-1 and alexidine/PQ-1 achieved greater than 3-log reductions against all organisms at all times. PQ-1/MAPD-1 and PQ-1/MAPD-3 achieved greater than 3-log reductions at seven or more days against all organisms. PQ-1/MAPD-2 did not achieve a greater than 3-log reduction at any time; some regrowth was observed. CONCLUSIONS: PHMB- and alexidine-based multipurpose solutions demonstrated significantly greater biocidal activity compared with PQ-1/MAPD-based agents against Gram-negative organisms commonly isolated and CIE-associated pathogens.
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Soluciones para Lentes de Contacto/farmacología , Lentes de Contacto/microbiología , Córnea/microbiología , Enfermedades de la Córnea/tratamiento farmacológico , Infecciones Bacterianas del Ojo/tratamiento farmacológico , Bacterias Gramnegativas/efectos de los fármacos , Infecciones por Bacterias Gramnegativas/tratamiento farmacológico , Enfermedades de la Córnea/microbiología , Infecciones Bacterianas del Ojo/microbiología , Bacterias Gramnegativas/aislamiento & purificación , Infecciones por Bacterias Gramnegativas/microbiología , HumanosRESUMEN
PURPOSE: To compare the amoebicidal effects of nephrite containing contact lens (CL) storage cases with conventional CL storage cases. METHODS: Acanthamoeba lugdunensis were inoculated onto 5% nephrite containing CL storage cases as well as conventional CL storage cases both with and without silicone hydrogel contact lenses (SHCLs). Then the amount of Acanthamoeba proliferation on CL storage cases and the number of adherent Acanthamoeba on SHCLs were determined and compared. The effects of multipurpose solution (MPS) with and without 1% or 5% nephrite solution on Acanthamoeba adhesion were analyzed. RESULTS: Nephrite containing CL storage cases showed more inhibitory effects on Acanthamoeba proliferation (p = 0.02) and significantly reduced the number of adherent Acanthamoeba on SHCLs compared with conventional CL storage cases, regardless of SHCLs generation (p = 0.001, p = 0.001 and p < 0.001, respectively). The number of adherent Acanthamoeba on the first generation of SHCLs was significantly reduced by MPS with 1% and 5% nephrite solutions (p = 0.03 and p = 0.004, respectively), but the numbers for the second and third generation SHCLs were not. CONCLUSIONS: Nephrite could be used as a new additive component for CL storage cases and multipurpose solutions to improve the disinfection effects on Acanthamoeba.
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Acanthamoeba , Lentes de Contacto , Desinfección , Hidrogeles , Silicio , SiliconasRESUMEN
PURPOSE: To compare the in vivo surface wettability of silicone hydrogel (SiHy) contact lenses pre-soaked overnight in different multipurpose solutions (MPS) and normal saline. METHODS: In this double-blinded, randomized and self-controlled study, 36 subjects were fitted with three pairs of contact lenses (senofilcon A) pre-soaked overnight in five different MPS and saline in a randomized order. Each pair of lenses (pre-soaked in two different solutions the night before) were worn for 15min before assessment of pre-lens non-invasive tear break-up time (PL-NITBUT) using the Medmont corneal topographer (video recording). Corneal integrity was assessed using a slit lamp and a resting interval of 20min was allowed between each pair of lenses to ensure post-lens wear corneal integrity. RESULTS: Thirty subjects completed the study. The median PL-NITBUT ranged from 2.84s to 3.08s with lenses pre-soaked in different MPS, compared to 2.78s with lenses pre-soaked in saline. No significant differences in PL-NITBUT were found among lenses pre-soaked in different solutions (p=0.647). CONCLUSION: In vivo surface wettability, in terms of PL-NITBUT after 15min of lens wear, of senofilcon A contact lenses pre-soaked overnight in different MPS were not significantly different from those pre-soaked in saline.
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Soluciones para Lentes de Contacto/química , Lentes de Contacto Hidrofílicos , Ajuste de Prótesis/métodos , Geles de Silicona/química , Lágrimas/química , Agentes Mojantes/química , Adulto , Método Doble Ciego , Diseño de Equipo , Análisis de Falla de Equipo , Femenino , Humanos , Hidrogeles/química , Masculino , Ensayo de Materiales , HumectabilidadRESUMEN
PURPOSE: To evaluate the effect of multipurpose contact lens care solutions (MPSs) on the adhesion of Acanthamoeba to rigid gas permeable (RGP) contact lenses. METHODS: Acanthamoeba castellanii (AC) trophozoites were inoculated onto untreated RGP contact lenses (FP, Extra, or Menicon Z), and numbers of trophozoites adhering to lenses were counted under a phase contrast microscope at 18 h post-inoculation (controls). Similarly, adhering trophozoites were counted at 6 h post-inoculation on each of the three RGP lens types with one of three MPSs (Boston Simplus, Menicare Plus, and O2 Care). Scanning electron microscopic examinations were performed to compare lens surfaces. RESULTS: Adhesion of AC trophozoites to untreated FP was greater than to untreated Extra or Menicon Z. Surfaces of Extra and Menicon Z lenses were waxier, smoother, and more homogeneous than those of FP lenses. After treatment with Boston Simplus, adhesion of AC trophozoites was significantly reduced for all lens types as compared with controls (p < 0.0001). Treatments with Menicare Plus or O2 Care reduced the number of adherent AC trophozoites significantly on FP lenses only as compared with controls (p < 0.0001). CONCLUSIONS: The adhesion rates of AC trophozoites to RGP lenses depended on lens surfaces. Boston Simplus reduced the adhesion rate of AC trophozoites more than Menicare Plus or O2 Care. Appropriate RGP lens and MPS selection could decrease the prevalence of Acanthamoeba keratitis.
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Acanthamoeba castellanii/efectos de los fármacos , Adhesión Bacteriana/efectos de los fármacos , Soluciones para Lentes de Contacto/farmacología , Lentes de Contacto/microbiología , Desinfectantes/farmacología , Análisis de Varianza , Humanos , Microscopía ElectrónicaRESUMEN
Block co-polymer surfactants have been used for cleaning hydrogel medical devices that contact the body (e.g., contact lenses) because of their biocompatibility. This work examined the relationship between concentration and detergency of two non-ionic polymeric surfactants (Pluronic F127 and Triton X-100) for cleaning protein soil, with anionic surfactants (sodium dodecyl sulfate and sodium laureth sulfate) as positive controls. Surface plasmon resonance was used to quantify removal of simulated tear soil from self-assembled monolayer surfaces, and a microplate format was used to study the removal of fluorescently labeled soil proteins from contact lenses. While detergency increased as a function of concentration for anionic surfactants, it decreased with concentration for the two polymeric surfactants. The fact that the protein detergency of some non-ionic polymeric surfactants did not increase with concentration above the critical micelle concentration could have implications for optimizing the tradeoff between detergency and biocompatibility.
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Incrustaciones Biológicas/prevención & control , Lentes de Contacto/microbiología , Hidrogeles , Octoxinol/química , Poloxámero/química , Tensoactivos/química , Detergentes/química , Gotas Lubricantes para Ojos/química , Dodecil Sulfato de Sodio/análogos & derivados , Dodecil Sulfato de Sodio/química , Soluciones , Resonancia por Plasmón de SuperficieRESUMEN
PURPOSE: To evaluate the safety and efficacy of a new multipurpose disinfecting solution (MPDS) with a formulation that includes aloe vera on its composition. METHODS: This is a prospective, randomized, double-masked clinical trial with a crossover design that included seven examinations. Two different MPDSs, Avizor Alvera® (study solution) and All Clean Soft® (control solution), each were used for 1 month. Comfilcon A silicone hydrogel contact lenses were used during the trial. The main outcome variables were corneal staining and deposits on the surfaces of the contact lenses. Other parameters including ocular surface response, contact lens wettability, user satisfaction, and adverse events, were analyzed according to the International Organization for Standardization (ISO) 11980:2010 guidance for clinical investigation. RESULTS: Twenty subjects (10 women, 10 men) (mean age, 27.7±5.6 years; range, 20-41) were included. No differences between both MPDSs were found in the percentage of subjects with corneal staining >0 at day 30 (study: 35%, control: 50%; p=0.46); neither in the percentage of subjects with deposits on the surface of the contact lens >0 at day 30 (study: 26.32%, control: 52.63%; p=0.18). The study MPDS received higher rates in comfort (study: 8.14±1.09, control: 7.94±0.92; p=0.56) and satisfaction at day 30 (study: 8.63±0.91, control: 8.29±0.80; p=0.19), however the scores were not significantly different with the control MPDS. CONCLUSIONS: The clinical trial showed that the study MPDS is safe, efficient, and has acceptable physiologic tolerance, according to the ISO 11980:2010 guidance for clinical investigation.
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Soluciones para Lentes de Contacto , Lentes de Contacto Hidrofílicos , Desinfección/métodos , Hidrogeles , Elastómeros de Silicona , Adulto , Soluciones para Lentes de Contacto/efectos adversos , Soluciones para Lentes de Contacto/normas , Estudios Cruzados , Desinfección/normas , Método Doble Ciego , Femenino , Humanos , Masculino , Satisfacción del Paciente , Estudios Prospectivos , Adulto JovenRESUMEN
PURPOSE: To evaluate the effects of a chemically preserved multipurpose contact lens care solution (MPS) on the corneal epithelial surface and Pseudomonas aeruginosa (PA) internalization in the rabbit corneal epithelium. METHODS: Rabbits were fit in one eye with a silicone hydrogel lens (balafilcon A) soaked overnight in a borate-buffered MPS (BioTrue). The contralateral eye was fit with a lens removed directly from the blister pack containing borate-buffered saline (control). Lenses were worn for 2 hours. Upon lens removal, corneas were challenged ex vivo with invasive PA strain 6487 and assessed for PA internalization. Ultrastructural changes were assessed using scanning electron (SEM) and transmission electron microscopy (TEM). RESULTS: Scanning electron microscopy showed frank loss of surface epithelium in MPS-exposed eyes, while control eyes exhibited occasional loss of surface membranes but retention of intact junctional borders. Transmission electron microscopy data supported and extended SEM findings, demonstrating the presence of epithelial edema in MPS-treated eyes. There was a 12-fold increase in PA uptake into the corneal epithelium following wear of the MPS-treated lens compared to control (P = 0.008). CONCLUSIONS: These data demonstrate that corneal exposure to MPS during lens wear damages the surface epithelium and are consistent with our previous clinical data showing an increase in bacterial binding to exfoliated epithelial cells following MPS use with resultant increased risk for lens-mediated infection. These findings also demonstrate that the PA invasion assay may provide a highly sensitive quantitative metric for assessing the physiological impact of lens-solution biocompatibility on the corneal epithelium.
Asunto(s)
Adhesión Bacteriana/efectos de los fármacos , Soluciones para Lentes de Contacto/efectos adversos , Lentes de Contacto/microbiología , Epitelio Corneal/microbiología , Infecciones Bacterianas del Ojo/tratamiento farmacológico , Infecciones por Pseudomonas/tratamiento farmacológico , Pseudomonas aeruginosa/efectos de los fármacos , Animales , Recuento de Colonia Microbiana , Modelos Animales de Enfermedad , Epitelio Corneal/patología , Infecciones Bacterianas del Ojo/microbiología , Infecciones Bacterianas del Ojo/patología , Microscopía Confocal , Infecciones por Pseudomonas/microbiología , Infecciones por Pseudomonas/patología , Pseudomonas aeruginosa/aislamiento & purificación , ConejosRESUMEN
PURPOSE: To evaluate whether the use of Biotrue multipurpose solution (MPS) could significantly reduce the likelihood with which patients drop out of using daily wear contact lenses (CLs) amongst 18-44-year-old frequent replacement CL wearers. METHODS: Daily wear CL subjects habitually using MPSs (other than Biotrue MPS) who reported an intent to imminently drop out of CL wear because of comfort and dryness complaints were recruited to participate in this investigation. Subjects were switched to Biotrue MPS and continued to use habitual CL types with the new MPS for 2 weeks. Subjects completed an online satisfaction questionnaire at baseline and after 2 weeks to assess the change in symptoms and the intent to drop out of CL wear. Six months after completion of the initial study, a follow-up survey was administered to a subset of the initial participants. RESULTS: A total of 153 daily wear (silicone hydrogel and hydrogel) subjects completed this 2-week study with Biotrue MPS. When measuring those with the highest propensity to drop out of lens wear (n=93) after switching to Biotrue MPS, 90% of subjects significantly reduced their likelihood of dropping out of CL wear (P<0.0001). Online interviews were conducted with 73 of the study participants 6 months after completion of the initial study. A total of 93% of participants responded that they were still wearing CLs at least once per week. Of the 7% of respondents who were not currently wearing lenses 6 months after the initial study, two had dropped out of lens wear completely, and three still wore lenses less than once per week. CONCLUSION: Patients intending to drop out of CL wear due to discomfort and dryness significantly reduced their propensity of discontinuing lens wear following use of Biotrue MPS. Six months after completion of the study, 93% of patients were still wearing CLs at least once per week.
RESUMEN
OBJECTIVE: Demonstrate that successful soft contact lens wearers using competitive multipurpose solutions report improvement in comfort with OPTI-FREE((R)) RepleniSH((R)) Multi-Purpose Disinfecting Solution (MPDS). METHODS: This 30-day, multicentered, open-label study enrolled 109 eligible soft contact lens wearers using COMPLETE((R)) Multi-Purpose Solution (MPS) Easy Rub((R)) or ReNu MultiPlus((R)) MPS. The test solution (OPTI-FREE((R)) RepleniSH((R)) MPDS) was dispensed for use in place of habitual care solutions. Subjects assessed their experience with their habitual solution (baseline) and the test solution (Day 30) using Likert-style questions. Contact lens acuity and biomicroscopy findings were recorded at each visit. RESULTS: The test solution was associated with a statistically significant improvement in instillation comfort (P = 0.02), end of day comfort (P < 0.0001), clear vision (P < 0.0001) and overall satisfaction (P < 0.001). Subjects reported the test solution enhanced their overall lens-wearing experience more effectively than their previous solution (P < 0.0001) and that they would continue test solution use after the study (P < 0.0001). CONCLUSIONS: The test solution was effective at improving comfort and overall contact lens experience compared to COMPLETE((R)) MPS Easy Rub((R)) or ReNu MultiPlus((R)) MPS in successful contact lens wearers. These results indicate that changing contact lens care solutions, even in successful lens wearers, may improve comfort and overall lens-wearing experience.