Clinical performance of different care systems with silicone hydrogel contact lenses
ABSTRACT To assess the clinical and subjective performance of a one-step hydrogen peroxide (H2O2) lens care system compared to a multi-purpose disinfecting system (MPDS) when used with silicone hydrogel (SiH) lenses.
This was an eight-week, contralateral (lens type) clinical trial with a randomized, cross-over (care system) design. The H2O2 system was Clear Care ((AO Sept Plus) CIBA VISION) and the MPDS was OPTI-FREE RepleniSH (Alcon) and the SiH materials were lotrafilcon B (Air Optix; CIBA VISION) and senofilcon A (Acuvue OASYS, Johnson & Johnson Vision Care). Investigators and subjects were masked to lens care and lens type, respectively. Clinical variables and ocular health assessments were conducted at a baseline, two-week and four-week visit for each cross-over phase. Comfort, dryness and vision were rated on 0-100 scales. Wearing times and comfortable wearing times were also recorded.
Twenty-six subjects were enrolled: nine male, 17 female, mean age (+/-standard deviation) 31+/-12 years (range 17-59 years) and 24 subjects completed the study. Clinical variables showed no difference between solutions (all p > 0.05), however one subject exhibited solution-induced corneal staining with both lens materials and the MPDS. There was no difference between solutions in subjective overall ratings of comfort, dryness or vision (p > 0.05). The H2O2 resulted in longer reported comfortable wearing times than the MPDS (10.93 +/- 1.71 vs 9.84 +/- 1.47 h; repeated measures ANOVA, p < 0.01).
While both lens care systems performed well with the SiH lenses used, the H2O2 resulted in a longer reported comfortable wearing time then the MPDS.
[Show abstract] [Hide abstract]
ABSTRACT: The aim of this study was to analyze the influence of different lens care systems in surface roughness and refractive index (RI) of contact lenses (CL). This information provides us with a better understanding of how care solutions affect CL materials. Several CL and three commercially available and appropriate lens care solutions were used (two polyhexamethylene biguanide and one hydrogen peroxide care systems). Lenses were immersed in the lens care systems, and then measurements with CLR 12-70 digital automated refractometer and atomic force microscopy analysis on Tapping mode were recorded. The measurements were performed before and after the lenses were immersed in each care solution. Significant changes were observed on the CL materials when exposed to lens care systems. All the materials changed, to a greater or lesser extent, their roughness and RI, after being immersed in the different solutions. The water content varied between 0% (Nelfilcon A in ReNu Multiplus, Senofilcon A in AOSEPT Plus, and Methafilcon A in Solocare Aqua) and 4.1% (Hilafilcon B in Solocare Aqua) The higher change in roughness was obtained with ReNu Multiplus in the lens Comfilcon A (with an increase of 27.2 nm) and Senofilcon A (with an increase of 16.7 nm). This study suggests that lens care systems play an important role in surface roughness and RI of CL.Eye & contact lens 05/2014; 40(3):140-7. DOI:10.1097/ICL.0000000000000023 · 1.68 Impact Factor
[Show abstract] [Hide abstract]
ABSTRACT: Purpose We aimed to evaluate the product performance of a novel one-step hydrogen peroxide cleaning and disinfecting solution, PeroxiClear (“Test” solution), when used by habitual Clear Care users to bilaterally clean and disinfect their soft contact lenses, for approximately 2 weeks. Methods This was a 2-week, open-label, bilateral eye study designed to include subjects ranging in age from 18 to 55 years, inclusive. All subjects were habitual users of the Clear Care peroxide regimen for cleaning, disinfecting, and storage of their soft contact lenses, for at least 6 months prior to enrolling in the study. Subjects were examined at two study visits: a screening/dispensing visit and a 2-week follow-up visit. The primary end point, patient preference for the Test solution, was evaluated with an online survey administered after 7 days of using the Test cleaning and disinfecting solution. Respondents could answer questions with neutral or nonneutral responses (better or worse). Statistical analyses were conducted to compare differences for nonneutral responses. Results Of the 299 eligible subjects enrolled, 297 completed the study, conducted at 21 sites by 21 investigators in the United States. A significantly higher proportion of nonneutral respondents reported the Test solution was better overall (85.9%) than their habitual contact lens solution (14.1%) (P<0.001). The proportion of subjects who preferred the Test solution over their habitual solution was significantly higher for each of the preference questions regarding comfort (85.4% vs 14.6%), moistness (90.0% vs 10.0%), cleanness (91.6% vs 8.4%), and clarity of vision (85.8% vs 14.2%). Conclusion After 7 days of using the Test cleaning and disinfecting solution, survey results indicated high levels of patient satisfaction and preference over the habitual solution, particularly in the areas of comfort, moisture, and cleanness.Clinical ophthalmology (Auckland, N.Z.) 10/2014; 8:2035-40. DOI:10.2147/OPTH.S69701
[Show abstract] [Hide abstract]
ABSTRACT: comMultipurpose solutions (MPSs) are the leading method for cleaning and disinfecting soft contact lenses (CLs). During recent years, numerous clinical studies have evaluated the MPS damage to the ocular surface. This study examined the cytotoxic and the inflammatory effects of MPSs and hydrogen peroxide disinfection system (H202) compared to appropriate controls on human corneal epithelial (HCE) cells. Primary cultured HCE cells were exposed to eight different commercially available MPS products (MPS A, ReNu MultiPlus®; MPS B, Opti Free® EverMoist; MPS C, Solo-care Aqua®; MPS-D, Complete®; MPS-E, Unica Sensitive®; MPS-F, Options Multi®; MPS-G, Biotrue®; MPS-H, COMPLETE® RevitaLens). Morphological changes and cytotoxic effects were examined with FITC-Annexin V/ PI and MTT assays. The protein contents of the inflammatory cytokines interleukin (IL)-1β, TNF-α, IL-6 and IL-8 were examined by multiplex fluorescent bead immunoassay (FBI), and the mRNA expression was examined by real time PCR. Lipopolysaccharide (LPS) with 500 ng/ml CD14 and 500 ng/ml LBP (LPS complex), polyinosinic: polycytidylic acid (Poly I:C) and un-neutralized H202 served as positive controls, respectively. Phosphate-buffered saline (PBS) was added as a negative control. The study demonstrated that most of the MPSs induced varying degrees of cytotoxicity to HCE cells, and increased production of pro-inflammatory cytokines compared to the negative control. In addition, several MPS increased the mRNA level of inhibitory factor-κBα (I-κBα). Among the various MPSs, MPS-H induced the highest protein contents of the pro-inflammatory cytokines (14.37±2.2-fold for TNF-α, 41.39±2.5-fold for IL-1β and 5.24±0.6-fold for IL-6) compared to the negative control (p<0.05). In contrast, no significant differences were noted between the neutralized H202 and the negative control. We conclude that most of the currently used MPSs induce significant damage and inflammatory response in corneal epithelial cells. MPS-induced inflammation was mediated through NF-κB signal transduction. This study demonstrates for the first time inflammatory responses at the molecular level in primary HCE cells following exposure to a large series of commercially available and commonly used MPSs. These findings strongly suggest that certain MPSs may be partially involved in the pathogenesis of contact lens intolerance. Therefore, we recommended that practitioners advise patients as to the preferable disinfecting contact lens solutions, and to consider using the hydrogen peroxide disinfection systems instead.European Journal of Inflammation 02/2013; 1(1):145-160. · 0.99 Impact Factor