The short-term physiological impact of switching reusable silicone hydrogel wearers into a hydrogel daily disposable multifocal.

Purpose: To evaluate ocular physiological responses to etafilcon A multifocal (etMF) daily disposable (DD) lenses after 4 weeks of wear, when switching from habitual silicone hydrogel (SiHy) daily wear. Method: A single-arm, open-label, bilateral dispensing study was conducted in 39 habitual spherical SiHy wearers (14 hyperopes; 25 myopes). Clinical visits occurred with habitual SiHy (control) at baseline and after 4 weeks of etMF DD open-eye lens wear at exit. Objective limbal/bulbar hyperemia using the Oculus K5M (0-4) and subjective grading of lid wiper epitheliopathy (LWE) (0-4) were tested for non-inferiority (NI), using a margin of 1 grade. Corneal thickness along a 10 mm cord was measured using the Visante OCT and tested for NI using a 30 µm margin. Corneal staining area was graded (0-100%). Results: The least-square mean differences (LSMD) and 95% confidence interval (95% CI) between etMF DD and habitual SiHy in central and peripheral corneal thickness (µm) were 3.64 (-2.0, 9.29) and 3.0 (-7.72, 13.72) in hyperopic, and 3.56 (-0.66, 7.78) and 6.40 (-1.62, 14.42) in myopic subjects. The LSMD (95% CI) for bulbar and limbal hyperemia were -0.08 (-0.19, 0.02) and -0.01 (-0.12, 0.09) in hyperopes, and 0.04 (-0.03, 0.12) and 0.04 (-0.04, 0.11) in myopes. The LSMD (95% CI) for LWE were 0.11 (-0.39, 0.60) and 0.30 (-0.07, 0.67) for hyperopes and myopes, respectively. Conclusions: No clinically significant differences in a variety of physiological responses were found when habitual reusable SiHy daily wear subjects were refitted into hydrogel etMF, when the subjects were followed for 4 weeks.

A novel scale for describing corneal staining.

The assessment of corneal staining is a commonly conducted procedure in both clinical practice and as part of various research studies. Different grading scales are employed by many clinicians and researchers to undertake this procedure for corneal staining comparisons between eyes, products and over time. This paper describes the development and use of a grading scale for corneal staining undertaken at an academic research site. The scale involves assessment of three factors across five corneal zones: type, area and depth. Staining type and area are graded on a 0-100 scale, and depth is graded on a 0-4 scale. These factors can be combined to create a three- or two-factor staining grade, or the factors may be reported individually. An additional benefit of this scale is that the staining scores may be reported by zone as "zone staining scores" or the scores of zones may be combined to provide an overall corneal "global staining score".

Corneal Swelling with Cosmetic etafilcon A Lenses versus No Lens Wear.

PURPOSE: To determine if the use of pigments or adding polyvinyl pyrrolidone during the fabrication of 1-DAY ACUVUE DEFINE (AD) brand contact lenses impacts open-eye corneal swelling compared with no lens wear (NLW). METHODS: A partial double-masked, randomized, bilateral crossover study was conducted in 24 Asian subjects using AD, 1-DAY ACUVUE DEFINE with Lacreon (ADL), NLW, and a control lens with no tint (1-DAY ACUVUE MOIST [AM]). Central corneal thickness was measured before insertion and immediately after removal after 8 ± 1 h of open-eye wear using an optical pachymeter in one eye. Corneal thickness along a 10-mm cord was measured in the contralateral eye using the Visante optical coherence tomographer (OCT). Corneal swelling was tested for noninferiority using a 5% margin. The endothelial bleb response was measured at baseline and 20 min after lens insertion using specular microscopy. Subjective grading of corneal staining and limbal/bulbar hyperemia were also monitored. RESULTS: After 8 ± 1 h of open-eye wear, central corneal swelling across the study lenses with either optical pachymeter or OCT methods was negligible. Peripheral corneal swelling least-square mean differences with OCT were -0.03% (95% confidence interval [95% CI], -0.65 to 0.58%) and -0.26% (95% CI, -0.87 to 0.36%) between AD and ADL and the control lens (AM), respectively, and 1.67% (95% CI, 1.06 to 2.29%) and 1.45% (95% CI, 0.84 to 2.06%) between AD and ADL and NLW, respectively. No endothelial blebs were observed. No clinically significant differences were distinguished between the lenses and NLW for corneal staining and limbal/bulbar hyperemia. CONCLUSIONS: After 8 ± 1 h of open-eye wear, central and peripheral corneal swelling along the horizontal meridian with AD, ADL, AM, and NLW were equivalent. These results confirm that the addition of polyvinyl pyrrolidone or pigments to etafilcon A to obtain a limbal ring design have no impact on corneal swelling or limbal/bulbar hyperemia during normal open-eye wear.

Overnight corneal swelling with high and low powered silicone hydrogel lenses.

PURPOSE: To compare central corneal swelling after eight hours of sleep in eyes wearing four different silicone hydrogel lenses with three different powers. METHODS: Twenty-nine neophyte subjects wore lotrafilcon A (Dk, 140), balafilcon A (Dk, 91), galyfilcon A (Dk, 60) and senofilcon A (Dk, 103) lenses in powers -3.00, -10.00 and +6.00 D on separate nights, in random order, and on one eye only. The contra-lateral eye (no lens) served as the control. Central corneal thickness was measured using a digital optical pachometer before lens insertion and immediately after lens removal on waking. RESULTS: For the +6.00 D and -10.00 D, lotrafilcon A induced the least swelling and galyfilcon A the most. The +6.00 D power, averaged across lens materials, induced significantly greater central swelling than the -10.00 and -3.00 D (Re-ANOVA, p<0.001), (7.7±2.9% vs. 6.8±2.8% and 6.5±2.5% respectively) but there was no difference between -10.00 and -3.00 D. Averaged for power, lotrafilcon A induced the least (6.2±2.8%) and galyfilcon A the most (7.6±3.0%) swelling at the center (Re-ANOVA, p<0.001). Central corneal swelling with +6.00 D was significantly greater than -10.00 D lens power despite similar levels of average lens transmissibility of these two lens powers. CONCLUSIONS: The differences in corneal swelling of the lens wearing eyes are consistent with the differences in oxygen transmission of the silicone hydrogel lenses. In silicone hydrogel lenses central corneal swelling is mainly driven by central lens oxygen transmissibility.

Clinical performance of three silicone hydrogel daily disposable lenses.

PURPOSE: To determine the clinical performance of DAILIES TOTAL1 (DT1), Clariti 1Day (C1D), and 1-DAY ACUVUE TruEye (AVTE) silicone hydrogel daily disposable contact lenses (SiHy DDCLs). METHODS: Eligible participants, subdivided into asymptomatic and symptomatic groups, wore each SiHy DDCLs for three consecutive days. Each participant attended three visits (on day 1 at 0 hours; on days 1 and 3 after 8 hours of wear) per lens type. The order of lens wear was randomized, with at least 1 day washout between lenses. Lens-related performance was evaluated by assessing lens surface deposits, wettability, pre-lens noninvasive tear breakup time, lens movement, and centration; ocular response assessments included conjunctival redness, corneal staining, and conjunctival staining and indentation. RESULTS: Fifty-one asymptomatic and 53 symptomatic participants completed the study. For all visits, the mean noninvasive tear breakup time was about 1 second longer with DT1 than with C1D and AVTE (p < 0.01). Overall, the wettability of all three lenses was good; however, DT1 was graded marginally better than the other lenses (both p < 0.01). On day 3, eyes wearing AVTE had significantly more dehydration-induced corneal staining compared with DT1 (AVTE, 24%; DT1, 11%; p < 0.01). After 8 hours, conjunctival staining was different between lenses (greatest with C1D and least with DT1; all p < 0.01). Conjunctival indentation was more prevalent with the C1D lenses (n = 70) compared with DT1 (n = 1; p < 0.01) and AVTE (n = 11; p < 0.01). There were no differences between asymptomatic and symptomatic lens wearers for any of the clinical parameters (all p > 0.05). CONCLUSIONS: Each of the three SiHy DDCLs performed well. Noninvasive tear breakup time was longest and wettability was greater with DT1. C1D had the most conjunctival staining conjunctival indentation. There was no difference between asymptomatic and symptomatic wearers with regard to ocular response and contact lens-related parameters. These results suggest that SiHy DDCLs may be an excellent contact lens modality for the symptomatic patient.

Comfort response of three silicone hydrogel daily disposable contact lenses.

PURPOSE: To evaluate subjective ocular comfort across the day with three silicone hydrogel daily disposables (SHDDs) in a group of adapted lens wearers. METHODS: Masked subjects (asymptomatic or symptomatic of end-of-day (EOD) dryness with habitual lenses) wore three SHDDs: DAILIES TOTAL1 (DT1), Clariti 1day (C1D), or 1-DAY ACUVUE TRUEYE (AVTE), each for 3 days. On day 2, wearing time (WT) and comfort ratings after insertion, at 4, 8, and 12 hours, and at EOD were recorded. Because not all subjects wore lenses for 12 hours, comfort was analyzed across the day (up to 8 hours, 8 to 12 hours), and a new variable ("cumulative comfort" [CC]) was calculated for EOD. RESULTS: One hundred four subjects completed the study (51 asymptomatic, 53 symptomatic). The two groups had different WTs (mean WT, 14.0 and 12.7 hours, respectively; p < 0.001). Ocular comfort was rated higher in the asymptomatic group throughout the day (p < 0.001). One hundred four subjects wore all three SHDDs for at least 8 hours, whereas 74 (45 asymptomatic, 29 symptomatic) subjects wore them for 12 hours or longer. Comfort ratings were higher with DT1 (least square means [LSM] = 91.0) than with C1D (LSM = 86.5; p < 0.001) and AVTE (LSM = 87.7; p = 0.011) for the first 8 hours and lower with C1D compared with DT1 (p = 0.012) from 8 to 12 hours. Mean EOD (± SD) comfort with the C1D lens was 72 ± 21, lower than both DT1 (mean, 79 ± 17; p = 0.001) and AVTE (mean, 78 ± 21; p = 0.010). Mean CC was higher in the asymptomatic group (mean, 1261 ± 59) compared with that in the symptomatic group (mean, 1009 ± 58; p < 0.001) and higher for DT1 (mean, 1184 ± 258) than C1D (mean, 1094 ± 318; p = 0.002) and AVTE (mean, 1122 ± 297; p = 0.046). CONCLUSIONS: All three SHDDs had average WTs of 12 hours or longer for 1 day. Comfort during the first 12 hours was highest with DT1 (similar to AVTE between 8 and 12 hours) and lowest with C1D. End-of-day comfort was lowest with C1D, and CC was highest for DT1. Cumulative comfort may be a valuable new metric to assess ocular comfort during the day.

Protein deposition and clinical symptoms in daily wear of etafilcon lenses.

PURPOSE: To determine the relationship between clinical signs and symptoms and protein deposition over 8 h of wear of etafilcon A lenses in symptomatic and asymptomatic contact lens wearers. METHODS: Thirty adapted soft contact lens wearers (16 symptomatic and 14 asymptomatic) were fitted with etafilcon A lenses. In vivo wettability, non-invasive tear break-up time, and subjective symptoms (vision, comfort, and dryness) were assessed at baseline and after 2, 4, 6, and 8 h. After 2, 4, 6, and 8 h time points, lenses were collected, and total protein, total lysozyme, and active lysozyme deposition were assessed. RESULTS: There was a significant reduction (p = 0.032) in the non-invasive tear break-up time at 8 h in both groups. In the symptomatic group, there was a significant reduction in subjective comfort and dryness ratings at 6 and 8 h measurement with respect to baseline (p < 0.05). There was a significant increase in total lysozyme and total protein deposition (p = 0.027) across all time points in both groups; most of the lysozyme remained active (>94% at 8 h). Pearson's correlations between subjective symptoms and protein deposition showed poor correlations for total protein/lysozyme and any subjective factor (r < 0.3; p > 0.05), and only weak correlations between dryness and % active lysozyme (r = 0.3 to 0.5 for all time points). However, stronger correlations were found between active lysozyme and subjective comfort (r = 0.6 to 0.7; p < 0.001). CONCLUSIONS: In addition to investigating total protein deposited on contact lenses, it is of significant clinical relevance to determine the conformational state of the deposited protein.

Estimating tear film spread and stability through tear hydrodynamics.

PURPOSE: The stability and ease of spread of the tear-film over the contact lens surface may be an indicator of contact lens surface dewetting. The present in vivo methods of determining lens dewetting are complex. This study introduces a novel and objective way of determining the upward spread and stability of the tear-film through measurement of tear-film particle dynamics. METHODS: Ten adapted contact lens wearers wore the same type of contact lens. Using a video camera mounted to a slit-lamp, the tear-film spread over the lens surface was recorded after a blink, at 8× magnification and capture rate of 30 frames per second, at morning after lens insertion, and after 8 h of lens wear. Images from 20 videos, without blinks and without an observable change in fixation were analyzed without any further postprocessing of the images. Using a customized calibrated ImageJ macro for particle tracking, the velocity of naturally occurring reflective particles was determined. The results were analyzed using the R program and ProFit. RESULTS: The results established that the upward particle velocity was highest immediately after a blink and declined with time. The spread of the tear film measured through upward particle velocity was different on lens insertion than after 8 h of lens wear (p = 0.001). The exponential time constants ± SE were 346.02 ± 29.0 for lens insertion at morning and 1413.13 ± 419.6 after 8 h of lens wear. CONCLUSIONS: A novel and non-invasive way to measure in vivo spread and stability of the prelens tear-film has been developed. Additional studies are needed to understand whether this simple measure is able to differentiate the performance of different soft contact lenses and how this method may help in the understanding other aspects of lens performance such as non-invasive tear breakup time, surface deposition, and lens comfort.

Distribution of overnight corneal swelling across subjects with 4 different silicone hydrogel lenses.

PURPOSE: To determine distribution of central corneal swelling (CCS) across subjects after 8 hr of sleep in eyes wearing silicone hydrogel lenses with various oxygen transmissibility (Dk/t) values and in eyes without lenses. METHODS: Twenty-nine neophytes wore lotrafilcon A (Dk, 140), balafilcon A (Dk, 91), galyfilcon A (Dk, 60), and senofilcon A (Dk, 103) lenses in powers -3.00, -10.00, and +6.00 diopters on separate nights, in random order, and on 1 eye only. The contralateral eye (no lens) served as the control. Central corneal thickness was measured using a digital optical pachometer before lens insertion and immediately after lens removal on waking. RESULTS: The average difference between the mean (7%) and the median (6.8%) CCS of all lenses was only 0.2%, suggesting a normal distribution. There was no correlation between the mean and the range of the CCS (r=0.058, P=0.766). Normal CCS distributions were also found with each lens-wearing eye and the control eye (P>0.20 for all). There was a significant correlation between lens-wearing eye and control eye (r=0.895, P<0.001) and between lotrafilcon A and each of the other 3 lenses for mean CCS across the study participants (P<0.001 for all). CONCLUSIONS: Distribution of corneal swelling in both lens-wearing eye and control eye followed a normal curve. An individual's corneal swelling response seems to be independent of lens type.

Measurement of the refractive index of soft contact lenses during wear.

PURPOSE: To determine whether the refractive index (RI) of a soft contact lens can be evaluated using refractometry while the lens remains on the eye and to compare this with more traditional ex vivo RI measurements. METHODS: A slitlamp apparatus was modified to incorporate a customized Atago hand refractometer. With a double-masked study design, nine adapted symptomatic soft contact lens wearers wore a contact lens in each eye (lotrafilcon B and etafilcon A) in a randomized order. In vivo RI was determined from the relative Brix scale measurements immediately after lens insertion and after 1 and 10 hr of lens wear. Ex vivo refractometry was performed after 10 hr of lens wear for comparison. Means +/- standard errors of the means are reported. RESULTS: In vivo RI values at baseline were 1.422 +/- 0.0004 (lotrafilcon B) and 1.405 +/- 0.0021 (etafilcon A); after 1 hr of lens wear, values were 1.423 +/- 0.0006 and 1.408 +/- 0.0007, respectively; and after 10 hr of lens wear, values were 1.424 +/- 0.0004 and 1.411 +/- 0.0010, respectively. Ex vivo RI values at the end of the 10 hr wearing period were 1.424 +/- 0.0003 (lotrafilcon B) and 1.412 +/- 0.0017 (etafilcon A). The change in in vivo RI across the day was statistically significant for the etafilcon A lens (repeated-measures analysis of variance, P<0.01) but not for the lotrafilcon B lens (P>0.05). CONCLUSIONS: This novel adaptation of refractometry was able to measure the RI of soft contact lenses during wear (without lens removal). End of day RI measurements using in vivo and ex vivo refractometry were comparable with each other. Future work is required to determine whether this in vivo method can improve our understanding of the relationships between soft contact lens RI, hydration, on-eye lens performance, and symptomology.

Ex vivo protein deposition on bi-weekly silicone hydrogel contact lenses.

PURPOSE: This study investigated the protein deposition that occurs on daily wear silicone hydrogel (SH) lenses, after 2 weeks of wear. METHODS: A total of 40 subjects were divided into equal groups, based on their habitual SH contact lens [CIBA Vision O2OPTIX (O2); Johnson & Johnson ACUVUE ADVANCE with HYDRACLEAR (ADV); Bausch & Lomb PureVision (PV); CIBA Vision Night & Day (ND)]. A randomized, double-masked, cross-over study was conducted in which subjects wore either their habitual SH material or Johnson & Johnson ACUVUE OASYS with HYDRACLEAR PLUS (OAS) for 2 weeks. At the end of the 2-week period, lenses were collected for analysis of total protein, total lysozyme, and percent denatured lysozyme. RESULTS: Total protein was greatest for PV (33 +/- 6 microg/lens), with other lenses depositing <10 microg/lens. The PV amount was greater than other materials (p < 0.001), with no significant differences between the other three materials (p > 0.05). Total lysozyme was also greatest for the PV lens (11 +/- 3 microg/lens), with other lenses depositing <2 microg/lens. The PV amount was greater than all other materials (p < 0.001). ADV and OAS were greater than O2 (p < 0.01) but were not different from each other (p > 0.05). The percentage of lysozyme that was denatured was greatest for ND (90 +/- 8%) and lowest for PV (23 +/- 10%). The lysozyme extracted from ND and O2 lenses was significantly more denatured than that extracted from the other lens materials (p < 0.001). There were no significant differences for lysozyme activity between ND and O2 (p > 0.05) or between ADV, OAS, and PV (p > 0.05). The amount of denatured lysozyme/lens was <3 microg/lens for all materials. Lysozyme as a percentage of the total protein deposited ranged from 32 (PV) to 6% (O2). CONCLUSIONS: This study confirms that all SH lenses deposit low levels of protein, and that the amount and percentage of denatured lysozyme can vary, depending on the overall surface charge of the material and absence or type of surface treatment.

The interblink interval I: the relationship between sensation intensity and tear film disruption.

PURPOSE: To find the relationship between tear film drying and sensation during the interblink period. METHODS: One eye was taped shut, and after a blink the subjects were required to keep the other eye open. Digital video images of the ocular surface (with fluorescein) were obtained using a slit lamp biomicroscope while 23 subjects rated the intensity of the ocular surface sensation by adjusting a one-turn potentiometer to represent the strength of the sensation. They were trained to use the potentiometer before the data were collected. In addition, the characteristics of the sensation as spoken by the subject were recorded. RESULTS: The sensation was generally triphasic, with initial constant sensation and a subsequent biphasic period, with intensity increasing slowly followed by a rapid increase before the subjects blinked (correlations were all r > 0.95). Tear film drying dynamics were also biphasic, and drying and sensation were strongly associated, with a correlation of 0.94 between the break in the bilinear functions of sensation and drying. CONCLUSIONS: The method provides novel information about the development of ocular sensation during ocular surface drying. As evidenced by the complex functions required to adequately describe the relationships, tear film drying and ocular surface sensations are associated in complex ways.

Atypical manifestation of upper lid margin staining in silicone hydrogel lens wearers with symptoms of dry eye.

PURPOSE: To report an atypical manifestation of upper lid margin staining (ULMS) that occurred in adapted silicone hydrogel (SH) contact lens wearers who complained of ocular surface dryness. METHODS: Sequential staining with sodium fluorescein (FL) and lissamine green (LG) strips was performed in 38 SH lens wearers. The "wiper area" of the upper lid was examined with the slit lamp, at 8x and 12x magnifications. RESULTS: Four out of 38 subjects (10.5%) showed fimbriated or "feathery" extensions from the superior margin of the subtarsal fold onto the upper tarsal plate. The extent of these feathery extensions varied between subjects, with a mean (+/-S.D.) length of 2+/-0.8 mm. In all cases a broad band of staining with both FL and LG was demonstrated, which extended along the entire length of the lid margin. CONCLUSION: The staining patterns shown on the subjects' upper lid margins and tarsal plates suggest that ULMS may include more complex variants. The putative tissue damage revealed through the staining, points to a mechanism not simply restricted to the upper lid margin.

Tear breakup dynamics: a technique for quantifying tear film instability.

PURPOSE: The purpose of this study was to develop a novel, quantitative measurement of tear film breakup dynamics (TBUD) to study the phenomenon of tear breakup in dry eye and control subjects and its impact on dry eye symptoms. METHODS: Ten control and 10 dry eye subjects completed the Dry Eye (DEQ) and other questionnaires. After the instillation of sodium fluorescein, subjects kept the tested eye open for as long as possible, similar to a staring contest, while tear film breakup was videotaped (S-TBUD). The maximum blink interval (MBI) and tear breakup time (TBUT) were measured from digital movies by a masked observer. Individual frames of movies were converted to gray-scale images, maps of relative tear film fluorescence were generated, and the total area of tear breakup (AB) of the exposed cornea was quantified. RESULTS: On average, dry eye subjects demonstrated a higher AB and shorter TBUT and MBI, but only the AB was significantly different (p = 0.023). Subjects most often used the descriptors stinging and burning to describe their sensations during staring trials. The AB showed a high correlation between eyes and with some DEQ symptom measures. CONCLUSIONS: These methods allow objective quantification and tracking of the phenomenon of tear breakup. Our results suggest that tear breakup stresses the corneal surface, resulting in stimulation of underlying nociceptors. The tear film of dry eye subjects was less stable than controls. They had a larger AB measured from the last video frame before MBI (i.e., just before blinking) than did controls. This perhaps reflects adaptation to the repeated stress of tear instability in dry eye.