BCLA CLEAR Presbyopia: Management with contact lenses and spectacles.

This paper seeks to outline the history, market situation, clinical management and product performance related to the correction of presbyopia with both contact lenses and spectacles. The history of the development of various optical forms of presbyopic correction are reviewed, and an overview is presented of the current market status of contact lenses and spectacles. Clinical considerations in the fitting and aftercare of presbyopic contact lens and spectacle lens wearers are presented, with general recommendations for best practice. Current options for contact lens correction of presbyopia include soft simultaneous, rigid translating and rigid simultaneous designs, in addition to monovision. Spectacle options include single vision lenses, bifocal lenses and a range of progressive addition lenses. The comparative performance of both contact lens and spectacle lens options is presented. With a significant proportion of the global population now being presbyopic, this overview is particularly timely and is designed to act as a guide for researchers, industry and eyecare practitioners alike.

Short-Term Fit Assessment of a Novel Daily Disposable, Toric, Silicone Hydrogel Contact Lens.

Purpose: The development of new contact lens materials and designs are necessary to minimise patient dropout. A lens material with water surface technology was recently developed to incorporate toric design. The on-eye stability of a toric contact lens is critical to a successful toric lens fitting. In an effort to establish if the new daily disposable verofilcon A toric silicone hydrogel lens provides fast stability for ease of fit, this study assessed the initial and short-term on-eye stability of this new lens. Patients and Methods: Habitual full-time wearers of soft contact lenses, aged 18 or over, were enrolled and fit with the verofilcon A toric lens. Study endpoints included lens settling time, axis orientation at specific time-points within 10 minutes after insertion, lens oscillation with blink, lens movement and centration, and scribe mark visibility. Results: Thirty-nine subjects completed the study; 67% were female and mean age was 34.1 ± 10.8 years (range 18 to 61). The majority of verofilcon A toric lenses (98.7%) settled on average within 60 seconds. Average lens orientation was 3° from six o'clock position within two minutes of insertion. The lenses showed minimal oscillation with blink; 98.7% of the eyes demonstrated ≤5° oscillation with blink. All lenses showed optimal/acceptable lens movement and centration and the scribe mark was reported as easily visible in 96% of eyes. Practitioners reported a 99% first lens fit success rate. Conclusion: The novel verofilcon A toric lens was highly successful with the first lens, had excellent on-eye stability and good fit characteristics. These qualities make this new lens a good option for lens wearers. Furthermore, it fulfills the needs of practitioners who want a toric lens that is easy and predictable to fit.

In vitro assessment of the biocompatibility of chemically treated silicone materials with human lens epithelial cells.

Cytotoxicity testing is a regulatory requirement for safety testing of new ocular implants. In vitro toxicity tests determine whether toxic chemicals are present on a material surface or leach out of the material matrix. A method of evaluating the cytotoxicity of ocular implants was developed using fluorescent viability dyes. To assess the assay's sensitivity in detecting toxic substances on biomaterials, zinc diethydithiocarbamate (ZDEC) and benzalkonium chloride (BAK) were deposited on silicone surfaces at different concentrations. Human lens epithelial cells (HLEC) were added to the surface of these treated silicone surfaces and were assessed for viability. The viability of both the adherent and non-adherent cells was determined using confocal microscopy with, annexin V, ethidium homodimer, and calcein. Cell metabolism was also evaluated using resazurin and the release of inflammatory cytokines was quantified using a multiplex Mesoscale Discovery platform. Confocal microscopy was shown to be a sensitive assay for evaluating material toxicity, as significant toxicity (p < 0.05) from ZDEC and BAK-treated surfaces compared to the untreated silicone control was detected. Patterns of cytokine release from cells varied depending on the toxin evaluated and the toxin concentration and did not directly correlate with the reduction in cell metabolic activity measured by alamarBlue.

Clinical Comparison of a Silicone Hydrogel and a Conventional Hydrogel Daily Disposable Contact Lens.

PURPOSE: To compare the subjective performances of verofilcon A daily disposable silicone hydrogel contact lenses (CLs) and etafilcon A hydrogel CLs. METHODS: Successful 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. RESULTS: Of 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. CONCLUSION: After 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.

Activity of Deposited Lysozyme on Contemporary Soft Contact Lenses Exposed to Differing Lens Care Systems.

PURPOSE: The amount of protein deposition on soft contact lenses and to what extent the proteins are denatured may have an impact on comfortable wearing times of contact lenses. The purpose of this study was to evaluate the effects of two lens care systems on total protein and the quantity and activity of lysozyme deposited on worn senofilcon A, silicone hydrogel contact lenses. PARTICIPANTS AND METHODS: Thirty symptomatic soft contact lens wearers were enrolled into a 4-week prospective, randomized, bilateral eye, daily-wear, crossover, double-masked study. Participants were fitted with biweekly senofilcon A lenses and were assigned either a polyquaternium-1 and myristamidopropyl dimethylamine-containing system (OPTI-FREE RepleniSH) or a peroxide-based system (CLEAR CARE). After each wear period, proteins were extracted from the lenses and analyzed for total protein, total lysozyme quantity and activity. RESULTS: The use of either the peroxide-based system or the polyquaternium-1 and myristamidopropyl dimethylamine-containing system resulted in no difference (P>0.05) to the amount of total protein deposited on the lenses (6.7 ± 2.8 micrograms/lens versus 7.3 ± 2.8 micrograms/lens, respectively) or to the amount of denatured lysozyme deposits (0.8 ± 0.7 versus 0.9 ± 0.7 micrograms/lens), respectively. The total amount of lysozyme deposited on the lenses was significantly lower when using the peroxide-based system (1.3 ± 0.9 micrograms/lens) compared to the polyquaternium-1 and myristamidopropyl dimethylamine-containing system (1.7 ± 1.0 micrograms/lens) (P=0.02). CONCLUSION: The inactivation of lysozyme deposited on senofilcon A lenses when disinfected with the peroxide-based or the polyquaternium-1 and myristamidopropyl dimethylamine-containing systems were neither statistically nor clinically significant and the overall amounts of denatured lysozyme recovered from the lenses were low (<1 microgram/lens).

Optimization of goblet cell density quantification methods.

The purpose of this study was to develop a standardized, accurate and efficient method for estimating conjunctival goblet cell density (GCD) via optimizing sample storage conditions and quantification methods. Conjunctival impression cytology (CIC) membranes were collected from both eyes of 32 participants and were randomized to two storage durations (2-3 weeks, 6-7 weeks) and two storage container types (microcentrifuge tube, flat histology cassette). The CIC membranes were stained and subdivided into 25 areas (5 mm × 5 mm) for imaging and the GCs were counted under 200X magnification using three different methods: (1) full CIC membrane GC count of the 25 images with cell-counting software ("full"; reference method), (2) partial membrane GC count of 9 images with cell-counting software ("partial"), and (3) manual counting of the 25 images ("manual"). In all cases, GCD was determined by dividing the GC count by the counting area. The average time required for quantification was recorded to gauge efficiency. Results showed no significant difference in GC count between the two storage durations (p = 0.745) or storage container types (p = 0.552). The median (interquartile range (IQR)) time required to quantify a CIC membrane for the full, partial, and manual methods of GC counting, was 14.8(17.6), 4.6(5.2) and 5.0 (5.0) minutes, respectively. The agreement of GCD values between the full and manual methods (bias: 0.4, 95% LOA: [-4.6, 5.5]) was stronger than that comparing the full and partial methods (bias: 0.5, 95% LOA: [-18, 17]). All together, through systematic examination of key procedural variables, an optimized method for GCD quantification within 7 weeks of sample collection was outlined. Adaption of procedures described in this paper to facilitate accurate and efficient GCD quantification may serve as a valuable step in clinical trials investigating DED pathophysiology and/or novel DED treatment strategies.

The Effect of Antimicrobial Peptides on the Viability of Human Corneal Epithelial Cells.

Antimicrobial peptides are polypeptides composed of less than 100 amino acids and are a class of antibiotics with strong activity against some infectious bacteria. This study examined the safety of four chosen antimicrobial peptides using primary human corneal epithelial cells (HCEC) and explored their potential therapeutic use. The efficacy of the peptides was also studied by evaluating the minimum inhibitory concentrations (MIC) against Gram-negative and Gram-positive bacteria. One of the peptides (polymyxin E) was found to have antibacterial efficacy against a common Gram-negative bacterium (MIC 1.56 µg/mL for Pseudomonas aeruginosa), and another one (nisin) was found to have antibacterial efficacy against a common Gram-positive bacterium (MIC 125 µg/mL for Staphylococcus aureus). Metabolic activity and live/dead/apoptotic effects were measured with fluorescent dyes after HCEC were exposed to the peptides for 30 min. Three of the peptides exhibited lower toxicity against HCEC than a currently marketed eye drop product. Regarding both efficacy and safety, two of the peptides (polymyxin E and nisin) were found to have potential use for treating ocular infections.

Lipid deposition on contact lenses in symptomatic and asymptomatic contact lens wearers.

PURPOSE: Lipid deposition on contact lenses (CL) has traditionally been believed to reduce comfort during CL wear. The purpose of this study was to quantify lipid deposition on CL in a group of symptomatic and asymptomatic adapted CL wearers. METHODS: This was a single-masked, randomized clinical trial. Only confirmed symptomatic (comfortable lens wear time (CWT) < 8 h and a noticeable reduction in comfort over the course of the day) and asymptomatic (CWT > 10 h and minimal reduction in comfort over the course of the day) participants were recruited to participate in the study. Participants wore senofilcon A lenses in combination with a polyquaternium-based care solution (OPTI-FREE Replenish). Worn CL samples were collected on Day 14. Deposited lipid amounts from the lenses (including cholesteryl ester, cholesterol and triolein) were quantified using a liquid chromatography-mass spectrometry technique. RESULTS: Lipid deposition was significantly higher in CL extracts of asymptomatic wearers compared to the symptomatic wearers for all lipid types quantified, including cholesteryl ester (2.1 ± 0.6 vs 1.6 ± 0.5 log µg/lens), cholesterol (1.5 ± 0.3 vs 1.1 ± 0.3 log µg/lens) and triolein (0.3 ± 0.2 vs 0.1 ± 0.1 log µg/lens) (all p < 0.002). The amount of cholesteryl ester deposited was greatest (p = 0.0001), followed by cholesterol, then triolein, for both the asymptomatic and symptomatic groups (both p = 0.0001). CONCLUSION: This study demonstrated that the asymptomatic group deposited a significantly greater amount of lipid on their CL. Although lipid levels measured are considered low to trigger any observable clinical deposition, they may influence other clinical outcomes, particularly comfort.

In vitro Evaluation of the Location of Cholesteryl Ester Deposits on Monthly Replacement Silicone Hydrogel Contact Lens Materials.

PURPOSE: The deposition profile of cholesteryl ester on the surface and throughout the matrix of silicone hydrogel contact lens (CL) materials was determined under conditions that mimic a daily wear regimen. METHODS: In this in vitro study, four SiHy CL materials (senofilcon C, lotrafilcon B, comfilcon A and samfilcon A) were incubated in an artificial tear solution (ATS) for up to 30 days. CL incubation was alternated between the ATS (16 hours) and a multipurpose care regimen (8 hours). The ATS included fluorescently tagged cholesteryl ester (5-cholesten-3ß-ol 6-[(7-nitro-2-1,3-benzoxadiazol-4-yl)amino]caproate; CE-NBD) and confocal laser scanning microscopy visualized the distribution of the lipid through the CLs. RESULTS: The distribution of CE-NBD was homogenous from the anterior to posterior surface in senofilcon C and comfilcon A, at all time points. For lotrafilcon B and samfilcon A, CE-NBD localization was heterogeneous, with greater amounts on the surfaces on Day 1 and Day 14 compared to the lens matrix; however, differences in concentration between the surface and bulk diminished by Day 30. CONCLUSION: The distribution of the non-polar lipid CE-NBD varied with lens material chemistry. While some lens materials deposited the lipid primarily on the surface after 16 hours of exposure, all materials exhibited a homogenous distribution after one month.

Effect of Artificial Tear Formulations on the Metabolic Activity of Human Corneal Epithelial Cells after Exposure to Desiccation.

Artificial lipid-containing tear formulations are developed to reduce tear evaporation by the restoration of a deficient tear lipid layer. Artificial tear formulations that prevent cell desiccation will result in ocular surface protection and the maintenance of cell metabolic activity. During dehydration, cells undergo the process of loss of metabolic activity and subsequently cell death. This work describes a method for assessing the efficacy of artificial tear formulations. The metabolic dye (i.e., alamarBlue) changes from a low fluorescent molecule resazurin to a fluorescent molecule resorufin in viable cells. The biological performance of an artificial tear formulation is measured as the ability of the formulation to (a) maintain cell viability and (b) provide cell protection from desiccation. Growth media and saline are used as controls for the cell viability/desiccation tests. Cells are incubated with test solutions for 30 min and then desiccated for 0 or 5 min at 37 °C and 45% relative humidity. Cell metabolic activity after initial exposure and after cell desiccation is then determined. The results show the comparative effects of eye drop formulations on cell metabolic activity and desiccation protection. This method can be used to test dry eye formulations that are designed to treat individuals with evaporative dry eye.

Kinetic Deposition of Polar and Non-polar Lipids on Silicone Hydrogel Contact Lenses.

Purpose: This study investigated kinetic lipid uptake to four silicone hydrogel (SiHy) lenses over a period of four weeks, using an in-vitro radiolabel method. Methods: Four contemporary monthly replacement SiHy lenses (lotrafilcon B, senofilcon C, comfilcon A, samfilcon A) were incubated in three different solutions: 1) An artificial tear solution (ATS) containing 14C-labeled phosphatidylcholine (PC), 2) an ATS containing 14C-cholesteryl oleate (CO) and 3) an ATS containing four 14C-radiolabeled lipids (PC, phosphatidylethanolamine, CO, and cholesterol (total lipid)). After 16 hours, lipids were extracted twice from the lenses with chloroform:methanol and the radioactive counts determined the lipid quantities to simulate 1 day of wear. OPTI-FREE PureMoist (Alcon) was used to clean and disinfect the remaining lenses daily and the lipid quantities were further determined after 2 weeks and 4 weeks. Results: The amount of total lipid increased for all lenses over time (p < .01). After four weeks, total lipid accumulated was 20.26 ± 0.15 µg/lens for senofilcon C, which was significantly higher (p < .01) than all other lens materials (samfilcon A - 17.84 ± 0.21; comfilcon A - 16.65 ± 0.12; lotrafilcon B - 7.41 ± 0.56 µg/lens). CO was highest on lotrafilcon B (1.26 ± 0.13 µg/lens) and senofilcon C attracted the most PC (3.95 ± 0.12 µg/lens) compared to the other materials. Conclusion: The amount of both polar and non-polar lipid deposition on monthly replacement SiHy lenses increased over 4 weeks, with significant differences being seen between lens materials.

Adhesion of Pseudomonas aeruginosa, Achromobacter xylosoxidans, Delftia acidovorans, Stenotrophomonas maltophilia to contact lenses under the influence of an artificial tear solution.

Corneal infection is a devastating sight-threatening complication that is associated with contact lens (CL) wear, commonly caused by Pseudomonas aeruginosa. Lately, Achromobacter xylosoxidans, Delftia acidovorans, and Stenotrophomonas maltophilia have been associated with corneal infection. This study investigated the adhesion of these emerging pathogens to CLs, under the influence of an artificial tear solution (ATS) containing a variety of components commonly found in human tears. Two different CL materials, etafilcon A and senofilcon A, either soaked in an ATS or phosphate buffered saline, were exposed to the bacteria. Bacterial adhesion was investigated using a radio-labeling technique (total counts) and plate count method (viable counts). The findings from this study revealed that in addition to P. aeruginosa, among the emerging pathogens evaluated, A. xylosoxidans showed an increased propensity for adherence to both CL materials and S. maltophilia showed lower viability. ATS influenced the viable counts more than the total counts on CLs.

Localization of full-length recombinant human proteoglycan-4 in commercial contact lenses using confocal microscopy.

The aim of this study was to determine the sorption location of full-length recombinant human proteoglycan 4 (rhPRG4) tagged with fluorescein isothiocyanate (FITC) to four silicone hydrogel contact lenses [balafilcon A (PureVision, Bausch + Lomb), senofilcon A (Acuvue Oasys, Johnson & Johnson), comfilcon A (Biofinity, CooperVision), lotrafilcon B (Air Optix, Alcon)] and one conventional hydrogel lens [etafilcon A (Acuvue 2, Johnson & Johnson)], using confocal laser scanning microscopy (CLSM). Lenses (n = 3 each) were incubated under two conditions: (1) FITC-rhPRG4 solution at 300 µg/mL and (2) phosphate-buffered saline, for 1 h at 37 °C in darkness with gentle shaking. The central 4 mm of each lens was removed and viewed with the Zeiss 510 CLSM using an argon laser at 488 nm (FITC excitation 495 nm, emission 521 nm). Depth scans were taken at 1 µm intervals to a maximum depth of 100 µm. All lens materials demonstrated sorption of rhPRG4. Both senofilcon A and balafilcon A revealed FITC-rhPRG4 penetration into the bulk of the lens, generally favoring the surface. rhPRG4 was observed exclusively on the surface of lotrafilcon B, with no presence within the bulk of the lens. rhPRG4 was evenly distributed throughout the bulk of the lens, as well as on the surface, for comfilcon A and etafilcon A. The sorption profile of FITC-rhPRG4 was successfully visualized using CLSM in various contact lens materials. The polymer composition, surface treatment and pore size of the material can influence the sorption of rhPRG4.

Cytomorphological assessment of the lid margin in relation to symptoms, contact lens wear and lid wiper epitheliopathy.

PURPOSE: Lid wiper epitheliopathy (LWE) is insufficiently understood from a cytological perspective. This study explored the relationship between lid margin cytomorphology, LWE, contact lens wear, and lens-related symptoms. METHODS: Habitual, symptomatic (n = 20) and asymptomatic (n = 20) soft, rigid gas permeable (n = 18) and non-contact lens wearers (n = 19) were enrolled. LWE was graded using lissamine green and the Korb scale. Subjective symptoms were assessed using the Ocular Surface Disease Index and the Contact Lens Dryness Evaluation Questionnaire. Impression cytology samples obtained from the central upper and lower lid margins of both eyes stained histologically to highlight keratinization and imaged using high-resolution microscopy. A masked investigator digitally delimited and measured the average sagittal width of the lid wiper conjunctiva and mucocutaneous junction using ImageJ. RESULTS: The upper lid wiper conjunctiva measured 424 ± 171 µm, 404 ± 75, 667 ± 219 and 266 ± 64 in asymptomatic soft, symptomatic soft, rigid and non-contact lens wearers, respectively. The corresponding lower lid wiper conjunctivae measured 141 ± 57 µm, 232 ± 150, 519 ± 212 and 225 ± 102, which was significantly narrower than that of the upper eyelid in most cases (p < 0.05). Symptoms were not associated with lid margin changes; however, rigid lens wear and clinical LWE were associated with histologically enlarged lid wiper conjunctival areas and increased keratinization. CONCLUSION: A novel, exploratory account of histological measures of LWE and cytomorphological change associated with contact lens wear suggests mechanical or frictional cellular insult is occurring at the lid wiper conjunctiva.

Uptake and Release of Polyvinyl Alcohol from Hydrogel Daily Disposable Contact Lenses.

SIGNIFICANCE: Polyvinyl alcohol is a wetting agent that could reduce the symptoms of dry eye and contact lens discomfort. Currently, only one lens type, nelfilcon A (DAILIES AquaComfort Plus), releases polyvinyl alcohol. The concept of releasing this agent from contact lenses could be applied to other lens materials. PURPOSE: The purpose of this study was to measure the release of polyvinyl alcohol from commercially available hydrogel daily disposable contact lenses using refractive index and iodine-borate methods. METHODS: Etafilcon A, omafilcon A, and nelfilcon A were soaked in phosphate-buffered saline and 0.2% trifluoroacetic acid/acetonitile for 24 hours to remove residual blister pack components. The lenses were then incubated in a 10-mg/mL solution of polyvinyl alcohol for 24 hours. After the incubation period, the lenses were placed in 2 mL of phosphate-buffered saline. At specified time intervals, t = 0.5, 1, 2, 4, 8, 12, and 24 hours, the samples were evaluated using refractive index and an iodine-borate assay. Polyvinyl alcohol uptake was determined by extracting the lenses with methanol for 24 hours. RESULTS: There were no differences in the uptake of polyvinyl alcohol between lens types (P > .05). The release of this wetting agent for all lens types followed a burst-plateau profile after the first 30 minutes (P > .05). Nelfilcon A had a slightly higher release of polyvinyl alcohol (P < .05) than did etafilcon A but was similar to omafilcon A (P > .05). CONCLUSIONS: The results suggest that the contact lenses tested in this study have similar efficiency in delivering polyvinyl alcohol.

Efficacy of Contact Lens Care Solutions in Removing Cholesterol Deposits From Silicone Hydrogel Contact Lenses.

PURPOSE: To determine the efficacy of multipurpose solutions (MPSs) on the removal of cholesterol deposits from silicone hydrogel (SH) contact lens materials using an in vitro model. MATERIALS AND METHODS: Five SH lens materials: senofilcon A, comfilcon A, balafilcon A, lotrafilcon A, and lotrafilcon B were removed from the blister pack (n=4 for each lens type), incubated for 7 days at 37°C in an artificial tear solution containing C radiolabeled cholesterol. Thereafter, lenses were stored in a preserved saline solution control (Sensitive Eyes Saline Plus) or cleaned with 1 of the 5 MPSs incorporating different preservatives (POLYQUAD/ALDOX, polyquaternium-1/alexidine, polyquaternium-1/PHMB, and 2 based on PHMB alone) using a rub and rinse technique, according to the manufacturer's recommendations, and stored in the MPS for a minimum of 6 hr. Lenses were then extracted with 2:1 chloroform:methanol, analyzed in a beta counter, and µg/lens of cholesterol was determined. RESULTS: Balafilcon A and senofilcon A lens materials showed the highest amounts of accumulated cholesterol (0.93±0.02 µg/lens; 0.95±0.01 µg/lens, respectively), whereas lotrafilcon A and lotrafilcon B deposited the lowest amounts (0.37±0.03 µg/lens; 0.47±0.12 µg/lens, respectively). For all lens materials, the MPS preserved with POLYQUAD/ALDOX removed more deposited cholesterol than any other test solution; however, the amount of removed cholesterol contamination from the individual contact lenses was only statistically significant for balafilcon A and senofilcon A (P=0.006 and P=0.042, respectively). Sensitive eyes and the other evaluated MPSs showed no significant effect on cholesterol removal (P>0.05). CONCLUSION: Cholesterol-removal efficacy varies depending on the combination of lens material and solution. Only 1 MPS showed a statistically significant reduction of cholesterol deposit for only 2 of the 5 tested lens materials.

Novel in vitro method to determine pre-lens tear break-up time of hydrogel and silicone hydrogel contact lenses.

PURPOSE: To develop an in vitro model to determine pre-lens non-invasive break-up time (NIBUT) and to subsequently use this method to compare the NIBUT over contemporary daily disposable (DD) contact lenses (CL). METHODS: Three silicone hydrogel (SH) and two conventional hydrogel (CH) DD CLs were incubated in an artificial tear solution (ATS). A model blink cell (MBC) was utilised to mimic intermittent air exposure. CLs were repeatedly submerged for 3 seconds (s) and exposed to air for 10 s over periods of 2, 6, 12, and 16 hours (h). NIBUTs (n = 4) were determined out of the blister pack (T0) and at the end of each incubation period. RESULTS: Overall, nesofilcon A showed the longest NIBUTs (p < 0.001). At T0, CHs revealed significantly longer NIBUTs (p ≤ 0.001) than SHs. After 2 h, nesofilcon A showed the longest NIBUT, however, this was only statistically significant compared with delefilcon A (p ≤ 0.001). After 6 h, nesofilcon A NIBUT was significantly longer than all other CLs (p ≤ 0.001). Etafilcon A showed a significantly longer NIBUT (p ≤ 0.001) after 12 h and delefilcon A had the longest NIBUT (p ≤ 0.001) after 16 h. Statistically significant (p ≤ 0.05) changes of NIBUT within the lens materials varied between time points. After 16 h, all CLs showed significant reductions in NIBUTs (p ≤ 0.001) in comparison to T0. CONCLUSION: NIBUT values reduced gradually over time and varying levels of deposition impacted measured pre-lens NIBUTs. While NIBUT of CH materials are longer immediately out of the blister pack, after tear film exposure, the NIBUTs obtained using this methodology became very similar.

Determination of the release of PEG and HPMC from nelfilcon A daily disposable contact lenses using a novel in vitro eye model.

The traditional method to measure release of components from CLs is a vial containing a static volume of PBS (phosphate buffered saline). However, this model does not simulate physiologically relevant tear volume and natural tear flow, air exposure, and mechanical rubbing. These factors can significantly impact release kinetics. We have developed an in vitro eye model (OcuFlow) that simulates these parameters. The aim of the study was to measure the release of PEG (polyethylene glycol), and HPMC (hydroxypropyl methylcellulose) from a daily disposable hydrogel contact lens material (nelfilcon A; Dailies AquaComfort PLUS; DACP;) over 24 hrs using the OcuFlow platform. The elution of PEG and HPMC from DACP lenses was analyzed using LCMS (liquid chromatography mass spectrometry). The release of all wetting agents from the lenses followed a burst release pattern, which occurred within the first 1.5 hrs (P < 0.05). The release of PEG was greater than that of HPMC (P < 0.05). The amount of PEG and HPMC released at any given time was less than 1% of the amount in the blister pack solution. Our results suggest that HPMC and PEG are rapidly released from the CL.

Surface versus bulk activity of lysozyme deposited on hydrogel contact lens materials in vitro.

PURPOSE: To determine and compare the levels of surface versus bulk active lysozyme deposited on several commercially available hydrogel contact lens materials. METHODS: Hydrogel contact lens materials [polymacon, omafilcon A, nelfilcon A, nesofilcon A, ocufilcon and etafilcon A with polyvinylpyrrolidone (PVP)] were incubated in an artificial tear solution for 16 h. Total activity was determined using a standard turbidity assay. The surface activity of the deposited lysozyme was determined using a modified turbidity assay. The amount of active lysozyme present within the bulk of the lens material was calculated by determining the difference between the total and surface active lysozyme. RESULTS: The etafilcon A materials showed the highest amount of total lysozyme activity (519 ±â€¯8 µg/lens, average of Moist and Define), followed by the ocufilcon material (200 ±â€¯5 µg/lens) and these two were significantly different from each other (p < 0.05). The amount of surface active lysozyme on etafilcon and ocufilcon lens materials was significantly higher than that found on all other lenses (p < 0.05). There was no active lysozyme quantified in the bulk of the nelfilcon material, as all of the active lysozyme was found on the surface (1.7 ±â€¯0.3 µg/lens). In contrast, no active lysozyme was quantified on the surface of polymacon, with all of the active lysozyme found in the bulk of the lens material (0.6 ±â€¯0.6 µg/lens). CONCLUSIONS: The surface and bulk activity of lysozyme deposited on contact lenses is material dependent. Lysozyme deposited on ionic, high water content lens materials such as etafilcon A show significantly higher surface and bulk activity than many other hydrogel lens materials.

The Effect of Denatured Lysozyme on Human Corneal Epithelial Cells.

Purpose: During contact lens wear, the amount of lysozyme deposited on contact lenses varies depending on the lens material. The binding of lysozyme to some contact lens materials may result in a conformational change that denatures the protein to an inactive form. This investigation evaluated the effect that denatured lysozyme has on human corneal epithelial cells (HCECs) by measuring cell viability and the release of inflammatory cytokines. Methods: HCECs were exposed to lysozyme that was denatured to various activity levels. After 24-hour exposure to the lysozyme (1.9 mg/mL) in growth media, the cells were evaluated for cell viability using confocal microscopy. The metabolic activity of the cells was determined using an alamarBlue assay. Cell supernatants were analyzed for inflammatory cytokines. Results: Using confocal microscopy, there was no detectable change in the viability of the HCECs after exposure to the denatured lysozyme. However, using alamarBlue, a decrease in the metabolic activity of the HCECs exposed to denatured lysozyme was detected. HCECs exposed to lysozyme that was 67%, 47%, and 22% active showed a reduction in metabolic activity when compared with native (100% active) lysozyme and the media controls (P < 0.05). Exposure to the denatured lysozyme also caused an increase in the release of inflammatory cytokines (P < 0.05) from the HCECs. Conclusions: The results of this study show that denatured lysozyme can have a detrimental effect on HCECs. Both a reduction in metabolic activity and an increase in the release of inflammatory cytokines occurred after HCEC exposure to denatured lysozyme.