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Evaluation of safety and efficacy of a new multipurpose disinfecting solution on silicone hydrogel contact lenses.

ABSTRACT: 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.

SUBMITTER: Pinto-Fraga J

PROVIDER: S-EPMC4314626 | biostudies-literature | 2015 Jan-Mar

REPOSITORIES: biostudies-literature

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Evaluation of safety and efficacy of a new multipurpose disinfecting solution on silicone hydrogel contact lenses.

Pinto-Fraga José J Blázquez Arauzo Francisco F Urbano Rodríguez Rubén R González-García María J MJ

Journal of optometry 20140808 1

<h4>Purpose</h4>To evaluate the safety and efficacy of a new multipurpose disinfecting solution (MPDS) with a formulation that includes aloe vera on its composition.<h4>Methods</h4>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 ...[more]

PMID: 25649640

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Project description:PurposeTo compare the subjective performances of verofilcon A daily disposable silicone hydrogel contact lenses (CLs) and etafilcon A hydrogel CLs.MethodsSuccessful wearers of spherical soft CLs for distance correction were prospectively randomized to wear verofilcon A or etafilcon A lenses for 1 week and crossed over to the alternative lenses. The primary study objective was a comparison of distance visual acuity (VA). Exploratory endpoints included subjective overall lens preference (5-point scale) and subjective ratings (10-point scales) of end-of-day (EOD) vision, overall handling, insertion comfort, EOD comfort, overall quality of vision, overall comfort, vision throughout the day, lens handling at insertion, and lens handling at removal.ResultsOf 92 subjects (184 eyes), 46 each were randomized to verofilcon A or etafilcon A lenses and subsequently crossed over to the other lenses. Evaluation of distance VA showed that verofilcon A lenses were noninferior to etafilcon A lenses. Comparison of lens preference showed that 68 (73.9%) subjects somewhat or strongly preferred verofilcon A lenses, whereas 21 (22.9%) somewhat or strongly preferred etafilcon A lenses (p<0.0001). Mean ± SD ratings of EOD vision (8.6±1.5 vs 7.7±1.9), overall handling (8.7±1.5 vs 6.9±2.3), insertion comfort (9.2±1.0 vs 7.7±1.9), and EOD comfort (8.0±1.9 vs 7.0±2.2) were all significantly (p≤0.0001 each) higher for verofilcon A than for etafilcon A lenses. Mean ± SD ratings of overall quality of vision (8.9±1.2 vs 8.2±1.8), overall comfort (8.6±1.5 vs 7.4±1.8), vision throughout the day (8.9±1.3 vs 8.1±1.8), lens handling at insertion (9.0±1.4 vs 6.9±2.5), and lens handling at removal (8.3±2.1 vs 7.7±2.2) were also significantly higher for verofilcon A lenses. No subject experienced any ocular adverse events.ConclusionAfter 1 week of wear, the study population reported that ratings for subjective endpoints were significantly higher for verofilcon A lenses than for etafilcon A lenses.

Project description:During the contact lens (CL) usage, microbial adhesion and biofilm formation are crucial threats for eye health due to the development of mature biofilms on CL surfaces associated with serious eye infections such as keratitis. For CL related eye infections, multi drug resistant Pseudomonas aeruginosa or Staphylococcus aureus (especially MRSA) and Candida albicans are the most common infectious bacteria and yeast, respectively. In this study, CL biofilm models were created by comparing them to reveal the differences on specific conditions. Then the anti-biofilm activities of some commercially available multipurpose CL solutions (MPSs) and antibiotic eye drops against mature biofilms of S. aureus, P. aeruginosa, and C. albicans standard and clinical strains were determined by the time killing curve (TKC) method at 6, 24 and 48 h. According to the biofilm formation models, the optimal biofilms occurred in a mixture of bovine serum albumin (20% v/v) and lysozyme (2 g/L) diluted in PBS at 37 °C for 24 h, without shaking. When we compared the CL types under the same conditions, the strongest biofilms according to their cell density, were formed on Pure Vision ? Softens 38 > Acuve 2 ? Softens Toric CLs. When we compared the used CLs with the new ones, a significant increase at the density of biofilms on the used CLs was observed. The most active MPS against P. aeruginosa and S. aureus biofilms at 24 h was Opti-Free followed by Bio-True and Renu according to the TKC analyses. In addition, the most active MPS against C. albicans was Renu followed by Opti-Free and Bio-True at 48 h. None of the MPSs showed 3 Log bactericidal/fungicidal activity, except for Opti-Free against S. aureus and P. aeruginosa biofilms during 6 h contact time. Moreover, all studied antibiotic eye drops were active against S. aureus and P. aeruginosa biofilms on CLs at 6 h and 24 h either directly or as 1/10 concentration, respectively. According to the results of the study, anti-biofilm activities of MPSs have changed depending on the chemical ingredients and contact times of MPSs, the type of infectious agent, and especially the CL type and usage time.

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Evaluation of safety and efficacy of a new multipurpose disinfecting solution on silicone hydrogel contact lenses.

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Evaluation of safety and efficacy of a new multipurpose disinfecting solution on silicone hydrogel contact lenses.

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