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.

Comparison of the Lubricity and Surface Roughness of 5 Cosmetic Contact Lenses.

OBJECTIVES: Cosmetic contact lenses are increasingly popular because of their eye enhancing cosmetic benefits. The pigment particles used in these lenses can impact lens surface characteristics. This article examines the surface characteristics and the differences between the clear and the pigmented regions among five limbal ring design lenses. METHODS: Scanning electron microscopy was used to determine the location and depth of the pigment particles from the lens surface. The coefficient of friction (CoF) was determined with a Basalt-MUST microtribometer at clear and pigmented regions on either the front or the back surface. Atomic force microscopy was used to determine the surface roughness of each lens in root-mean-square (RMS) units at clear and pigmented regions. A linear mixed model for repeated measures was used for the analysis of the CoF and RMS roughness to compare all lenses. RESULTS: Four lens types had pigments exposed on the surface and one lens type had pigment fully enclosed. The CoF difference between clear and pigmented regions were similar and not statistically significant (P=0.0124) for the lens type with pigments enclosed, whereas the CoF difference for the other four lens types showed statistically significant difference (P<0.0001). CONCLUSIONS: Of the lenses tested here, cosmetic contact lenses with pigments enclosed in the lens matrix provided a more consistent surface between clear and pigmented regions compared with lenses that had exposed pigments.

Theoretical fitting characteristics of typical soft contact lens designs.

PUROSE: To calculate theoretical fitting success rates (SR) for a range of typical soft contact lens (SCL) designs using a mathematical model. METHOD: A spreadsheet mathematical model was used to calculate fitting SR for various SCL designs. Designs were evaluated using ocular topography data from 163 subjects. The model calculated SR based on acceptable edge strain (within range 0-6%) and horizontal diameter overlap (range 0.2-1.2mm). Where lenses had multiple base curves (BCs), eyes unsuccessful with the steeper BC were tested with the flatter BC and aggregate SR calculated. Calculations were based on typical, current, hydrogel and silicone hydrogel SCLs and allowed for appropriate on-eye shrinkage (1.0-2.3%). Theoretical results were compared with those from actual clinical trials. RESULTS: Theoretical success rates for one-BC lenses ranged from 60.7% (95% CI 7.2%) to 90.2% (95% CI 3.7%). With two-BC designs, most combinations showed a SR increase with a second BC (84.0%-90.2%). However, one of the two-BC combinations showed only negligible increase with a second BC (72.4%-73.0%). For designs with lower SR, the greatest contributor to failure was inadequate lens diameter. For a given design, differences in shrinkage (i.e. on-eye bulk dehydration) had a significant effect on success rate. In comparison with historical clinical data, there was a positive correlation between small lens fitting prevalence and discomfort reports (r=+0.95, P=<0.001) with a poor correlation between theoretical and actual tight/loose fittings. CONCLUSIONS: Mathematical modelling is a useful method for testing SCL design combinations. The results suggest that judicious choice of additional fittings can expand the range of fitting success.

Inter-relationship of Soft Contact Lens Diameter, Base Curve Radius, and Fit.

PURPOSE: To evaluate the inter-relationship of soft contact lens base curve radius (BC), diameter, and lens fit using a mathematical model. METHODS: A spreadsheet mathematical model was used to evaluate theoretical fitting characteristics for various combinations of soft lens BC and diameter. The designs were evaluated using ocular topography data collected from 163 UK subjects. The model evaluated lens tightness (edge strain) and on-eye diameter (horizontal corneal overlap) and assumed that acceptable values fell within the range 0 to 6% and 0.2 to 1.2 mm, respectively. Analyses were undertaken of various trends relating to soft lens fit, including (1) the effect of BC and diameter on fitting success; (2) the effect of lens asphericity, BC, and sag on lens diameter on the eye; and (3) the effect of lens diameter on lens tightness. RESULTS: The highest overall success rate (90.2%) was achieved with an 8.60/14.2 mm (BC/diameter) design. Using this design on the sample population, the median edge strain value was 3.2% (IQR: 2.1%) whereas median corneal overlap was 0.62 mm (IQR: 0.35). There was a positive correlation (r = 0.37, P < .0001) between edge strain and corneal overlap. Edge strain showed significant correlations with each of the ocular topography variables, most notably corneal asphericity (-0.62, P < .0001). Corneal overlap showed significant correlations with corneal asphericity (r = -0.42, P < .0001) and corneal diameter (r = 0.92, P < .0001). For a 0.4 mm change in BC, it is necessary to change diameter by 0.2 mm to maintain similar on-eye diameter (arclength). When changing lens diameter, a change in BC of 0.2 mm is required to maintain similar tightness of fit. CONCLUSIONS: Mathematical modeling is a useful technique for large-scale evaluation of the interactions of soft contact lens design and fit. The study has given useful insights into the general performance of soft lens designs.

Friction Measurements on Contact Lenses in a Physiologically Relevant Environment: Effect of Testing Conditions on Friction.

PURPOSE: To characterize the effect of lubricant composition and in vitro ageing on the coefficient of friction (CoF) of a wide range of commercially available soft contact lenses (SCLs). METHODS: The CoF of SCLs was characterized by means of microtribometry against a mucin-coated glass disk. One reusable (RU) silicone-hydrogel (SiHy) lens, senofilcon A, and two daily disposable (DD) lenses, etafilcon A (hydrogel) and nelfilcon A (hydrogel), were tested under different lubricant solutions, including a tear-like fluid (TLF) containing proteins and lipids. Five RU (balafilcon A [SiHy], comfilcon A [SiHy], etafilcon A [hydrogel], lotrafilcon B [SiHy], senofilcon A [SiHy]) and five DD (delefilcon A [SiHy], etafilcon A [hydrogel; two lens types], narafilcon A [SiHy], nelfilcon A [hydrogel]) lenses were tested before and after exposure to an in vitro ageing process, consisting of continuous immersion and withdrawal from TLF for 18 hours. The CoF in TLF was further compared to previously published data collected in a different lubricant. RESULTS: After in vitro ageing, three RU (balafilcon A, etafilcon A, comfilcon A) and three DD (delefilcon A, etafilcon A, nelfilcon A) lenses displayed a significant increase in CoF (P < 0.05). Lenses that contained poly (vinyl pyrrolidone; PVP) showed unaltered CoF after ageing. CONCLUSIONS: An in vitro methodology to simulate in vivo wearing of contact lenses has been proposed. The results suggest that certain lens materials show increased CoF after ageing, with potential clinical implications. The results indicate that the presence of a persistent wetting agent is of advantage to maintain a low CoF after prolonged wearing.

Characterizing Contact Lens-Related Corneal Infiltrates: A Pilot Study.

PURPOSE: To document the time course and resolution of contact lens-related corneal infiltrative events (CIEs) comparing slit-lamp images with anterior segment ocular coherence tomography (AS-OCT) images. METHODS: Six silicone hydrogel (SiHy) soft contact lens (SCL) wearers presenting with newly diagnosed symptomatic CIEs were monitored with slit-lamp images, detailed drawings, and AS-OCT until the resolution of the CIE. A final follow-up visit was completed 4 weeks after CIE resolution to determine whether scar formation was present. Positive controls were 2 SiHy SCL wearers with established (inactive) corneal scars, and negative controls were 2 SiHy SCL wearers with clear corneas. High- and low-contrast logMAR visual acuities were measured, and subjective symptom questionnaires were completed at all visits. RESULTS: Clinical signs, vision, and symptoms improved in tandem with the resolution of the CIEs as measured by imaging methods. Calibrated measures of infiltrate width from a slit-lamp biomicroscope appear to be similar to calibrated images from AS-OCT. CONCLUSIONS: Although further studies are needed to develop standardized procedures, AS-OCT can be a useful tool to characterize the development, progression, and resolution of corneal infiltrates as an objective measure of resolution and scar formation.