Performance evaluation of delefilcon a water gradient daily disposable contact lenses in first-time contact lens wearers.

PURPOSE: To evaluate the tolerability of and subject and investigator satisfaction with delefilcon A (DAILIES TOTAL1®) daily disposable contact lenses in first-time contact lens wearers. METHODS: This European multicenter, open-label, single-arm, two-week trial enrolled first-time contact lens wearers and fitted them with delefilcon A contact lenses. Assessments were made at dispensing and at Weeks 1 and 2. Subject-reported outcomes included comfort, quality of vision, convenience, and intent to purchase, which were ranked by agreement responses. Investigator-reported outcomes included slit-lamp biomicroscopy findings and lens fit satisfaction. RESULTS: Ninety-two subjects were included in the per protocol dataset. Mean scores at Weeks 1 and 2 for subject-reported quality of vision and ocular comfort were significantly higher with delefilcon A contact lenses than with the subjects' habitual spectacles during the day, at the end of the day, and overall (all p ≤ 0.02). Ninety-one percent of subjects reported that their study lenses were more comfortable than expected, 98% agreed that they were convenient to use, and 92% were interested in purchasing the lenses (all p < 0.001). Investigators reported that study lenses had an acceptable fit in at least 97% of subjects. CONCLUSIONS: Practitioners can expect favorable outcomes when transitioning first-time contact lens wearers from spectacles to delefilcon A daily disposable contact lenses.

The impact of lens care solutions on corneal epithelial changes during daily silicone hydrogel contact lens wear as measured by in vivo confocal microscopy.

PURPOSE: To assess corneal epithelial microstructure via confocal microscopy and determine if cellular changes are associated with lens care solutions during daily wear of silicone hydrogel contact lenses. METHODS: Corneal in vivo confocal microscopy with the Nidek ConfoScan4 was performed at baseline and after 5 months of lotrafilcon A daily contact lens wear. Enrolled participants were randomized to use either a polyhexamethylene biguanide (PHMB) preserved multipurpose care solution (MPS) or a peroxide based solution system. Lens and storage case bioburden were assessed with aerobic culture methods. Univariate and multivariable analyses were done to evaluate the association between solution use, or solution-related clinical covariates, and morphologic differences (hyper-reflectivity) in the superficial epithelial cells and epithelial basal cell density. RESULTS: Data on 139 participants were available for analysis of superficial epithelial cells while data on 92 participants were available for epithelial basal cell density. Five months after randomization to the solution groups, 33% of participants had visible hyper-reflective cells. More participants using MPS had ≥1 hyper-reflective cells compared to peroxide users at 5 months (44% vs. 22%; p=0.006). Similarly at 5 months, more participants with solution-induced corneal staining (SICS) had ≥1 hyper-reflective cells compared to non-SICS participants (57% vs. 29%; p=0.010). The adjusted odds ratios (ORs) for risk of presenting with hyper-reflective cells in MPS users or SICS participants was 2.7 (95% CI; 1.27-5.65) and 3.4 (95% CI; 1.29-8.97), respectively. Basal cell density decreased by over 350 cells/mm2 over time (about 6%) in participants who had substantial bioburden on their lenses or in their storage case. CONCLUSION: The confocal microscope can detect epithelial cellular changes in vivo during contact lens wear. Hyper-reflective superficial epithelial cells are associated with a PHMB preserved solution and decreases in basal epithelial cell density may be associated with bacterial bioburden.

Soft Contact Lens-Related Symptoms in North America and the United Kingdom.

PURPOSE: To characterize and compare the prevalence of soft contact lens-related (SCL) dryness symptoms in large populations of SCL wearers in North America (NAm) and the United Kingdom (UK). METHODS: SCL wearers from NAm (n = 1443) and UK (n = 932) sites completed self-administered questionnaires on SCL symptoms and wearing experiences. A categorization for contact lens-related dry eye (CL-DE) was applied that combined Contact Lens Dry Eye Questionnaire (CLDEQ) items on dryness frequency and intensity at the end of the day (CL-DE+ = constantly/frequently/sometimes plus intensity = 3-5, and CL-DE- = never/rarely plus intensity = 0-1, Marginal = all other ratings). Data were analyzed across regions and categories, with p-values <0.05 significant. RESULTS: Compared to UK wearers, those in NAm wore fewer toric and multifocal designs, and reported significantly longer average and comfortable wearing times (p < 0.001) but similar levels of general and end-of-day comfort. The prevalence of CL-DE+ differed between the UK and NAm: CL-DE+: 31 vs. 39%, Marginal CL-DE: 13 vs. 14%, and CL-DE-: 56 vs. 47%, p = 0.0001. Although daily disposable (DD) lenses were worn more commonly in the UK than NAm (33 vs. 10%, p < 0.0001), their use did not impact the overall prevalence of dryness symptoms. Between regions, NAm wearers reported significantly more frequent and intense end-of-day discomfort and dryness (p < 0.0001) and were significantly more likely to use treatments for CL-related symptoms yet experienced a lower degree of relief. CONCLUSIONS: SCL wearers in NAm reported longer hours of wear with significantly more symptoms of dryness and discomfort. NAm wearers used dryness treatments more often, but experienced less relief than UK wearers. In both regions, the CL-DE categorization was useful to predict poorer comfort, shorter comfortable wearing time, and increased use of treatments. These results highlight the need to benchmark SCL performance locally or regionally to understand and focus on the challenges to the lens wearing experience.

Daily disposable contact lenses versus spectacles in teenagers.

PURPOSE: To compare clinical and subjective quality-of-life (QoL) data for teenagers wearing daily disposable contact lenses or spectacles. METHODS: This open-label study randomized subjects (aged 13 to 19 years) with no previous contact lens wear experience to nelfilcon A (DAILIES AquaComfort Plus) contact lenses or spectacles for 6 months. A full clinical workup, as well as subjective QoL measures using the Pediatric Refractive Error Profile and Quality of Life Impact of Refractive Correction questionnaires, was conducted at baseline and at week 4 and months 3 and 6, with an additional study visit at week 2 for subjects randomized to wear contact lenses. RESULTS: A total of 110 teenagers were enrolled in the study; 13 discontinued before study completion, 10 (17.5%) from the contact lens group and 3 (5.7%) from the spectacle group (p = 0.04). Visual acuity was good for both groups at all study visits. Biomicroscopy assessments were similar at baseline for both groups. Significant differences in Pediatric Refractive Error Profile responses were noted between vision correction groups across visits for appearance (p < 0.001), satisfaction (p < 0.001), activities (p < 0.001), peer perception (p = 0.003), and overall score (p < 0.001). For Quality of Life Impact of Refractive Correction, the contact lens group gave more favorable responses than the spectacle group (p = 0.02). After 6 months of wearing contact lenses, teenagers had a more positive attitude toward comfort, vision, and safety with contact lenses. No serious adverse events were reported during the study. CONCLUSIONS: The daily disposable lenses used in this study are suitable for vision correction for teenagers, offering improvements in QoL measures during the first month of wear, including appearance, satisfaction, activities, and peer perceptions, without negatively impacting vision or eye health. Teenagers were able to handle contact lenses with the same amount of confidence as spectacles.

Risk factors for microbial bioburden during daily wear of silicone hydrogel contact lenses.

PURPOSE: To assess risk factors associated with substantial microbial bioburden of lids, conjunctivae, contact lenses, and storage cases during daily wear of silicone hydrogel contact lenses. METHODS: Two hundred eighteen patients were fit to lotrafilcon A lenses, randomized to use either a multipurpose solution or a hydrogen peroxide care system, and followed up for 1 year. Lenses, lens transport saline, lids, conjunctivae, and storage cases were cultured and considered to have substantial microbial bioburden when they harbored high levels of commensal or pathogenic organisms. Univariate and multivariate logistic regression analyses were conducted to examine which demographic covariates were associated with significant bioburden at each location while controlling for solution use. RESULTS: In multivariate analyses, smoking trended toward an association with lens bioburden (odds ratio [OR]=2.15, 95% confidence interval [CI]: 0.95-4.88). Clerical occupations were found to be associated with more frequent overall storage case contamination (OR=3.51, 95% CI: 1.15-10.70) and, specifically, higher gram-positive storage case contamination (OR=5.57, 95% CI: 1.82-17.06). The peroxide system was associated with more frequent storage case contamination (OR=7.6, 95% CI: 3.79-15.19). Coagulase-negative staphylococci (CNS) were the most frequently cultured organisms within storage cases, and in multivariate analyses, CNS were more frequently found in storage cases of peroxide users (OR=6.12, 95% CI: 2.91-13.09). CONCLUSIONS: Clerical occupations were associated with increased microbial bioburden of storage cases during daily wear of silicone hydrogel lenses. Smoking may increase the risk of lens contamination. Storage cases are most frequently contaminated with normal skin flora, and peroxide cases were associated with more frequent contamination. However, the solution type was not associated with lid or lens contamination nor with corneal infiltrative events in this study.

Systane® ultra lubricant eye drops for treatment of contact lens-related dryness.

OBJECTIVES: To assess the clinical performance of Systane Ultra lubricant eye drops in daily disposable soft contact lens wearers who experience contact lens-related dryness. METHODS: In this randomized, investigator-masked study, daily disposable lens wearers with symptoms of dryness were randomized to use Systane Ultra lubricant eye drops or to no treatment. The lubricant regimen was applied twice a day, 10 minutes before lens insertion and after lens removal, for the 2-week study period. Subjective comfort, wear time, and visual acuity were assessed at baseline and after 2 weeks. RESULTS: A total of 89 daily disposable lens wearers were randomly assigned to the Systane Ultra group (n=44) or the control group (n=45). Two weeks of Systane Ultra lubricant eye drop use resulted in a significant increase in comfortable lens wear time when compared with baseline assessment (P=0.001) and a trend toward significant improvement compared with the control group (P=0.078). End-of-the-day comfort was significantly improved in the Systane Ultra group compared with the control group (P=0.007). A significant reduction in the overall dryness (P<0.001) and end-of-day dryness (P=0.047) was observed in subjects using the Systane Ultra lubricant eye drops compared with the control group. CONCLUSION: The study demonstrates that Systane Ultra lubricant eye drops applied before and after contact lens wear is an effective artificial tear for alleviating symptoms of contact lens-related dry eye.

Corneal inflammatory events with daily silicone hydrogel lens wear.

PURPOSE: This study aimed to determine the probability and risk factors for developing a corneal inflammatory event (CIE) during daily wear of lotrafilcon A silicone hydrogel contact lenses. METHODS: Eligible participants (n = 218) were fit with lotrafilcon A lenses for daily wear and followed up for 12 months. Participants were randomized to either a polyhexamethylene biguanide-preserved multipurpose solution or a one-step peroxide disinfection system. The main exposures of interest were bacterial contamination of lenses, cases, lid margins, and ocular surface. Kaplan-Meier (KM) plots were used to estimate the cumulative unadjusted probability of remaining free from a CIE, and multivariate Cox proportional hazards regression was used to model the hazard of experiencing a CIE. RESULTS: The KM unadjusted cumulative probability of remaining free from a CIE for both lens care groups combined was 92.3% (95% confidence interval [CI], 88.1 to 96.5%). There was one participant with microbial keratitis, five participants with asymptomatic infiltrates, and seven participants with contact lens peripheral ulcers, providing KM survival estimates of 92.8% (95% CI, 88.6 to 96.9%) and 98.1% (95% CI, 95.8 to 100.0%) for remaining free from noninfectious and symptomatic CIEs, respectively. The presence of substantial (>100 colony-forming units) coagulase-negative staphylococci bioburden on lid margins was associated with about a five-fold increased risk for the development of a CIE (p = 0.04). CONCLUSIONS: The probability of experiencing a CIE during daily wear of lotrafilcon A contact lenses is low, and symptomatic CIEs are rare. Patient factors, such as high levels of bacterial bioburden on lid margins, contribute to the development of noninfectious CIEs during daily wear of silicone hydrogel lenses.

Rapid image evaluation system for corneal in vivo confocal microscopy.

PURPOSE: To develop rapid image processing techniques for the objective analysis of corneal in vivo confocal micrographs. METHODS: Perpendicular central corneal volume scans from healthy volunteers were obtained via laser in vivo confocal microscopy. The layer in each volume scan that contained the nerve plexus was detected by applying software operators to analyze image features on the basis of their size, shape, and contrast. Dendritic immune cells were detected in the nerve image on the basis of cellular size, lack of elongation, and brightness relative to the nerves. Images that were 20 µm anterior to the best nerve layer images were used for the analysis of epithelial wing cells; wing cell detection was based on extended regional minima and a watershed transformation. RESULTS: The software successfully detected the best nerve layer images in 15 scans from 15 eyes. Manual and automatic analyses were 81.8% in agreement for dendritic immune cells (for 11 cells in a representative image) and 94.4% in agreement for wing cells (for 466 cells in the image). Within 10 seconds per scan, the software calculated the number, mean length, and mean density of immune cells; the number, mean size, and mean density of wing cells; and the number and mean length of nerves. Factors defining the shape and position of cells and nerves also were available. CONCLUSIONS: The software rapidly and accurately analyzed the in vivo confocal micrographs of the healthy central corneas, yielding quantitative results to describe the nerves, dendritic immune cells, and wing cells.

Soft contact lens-related dryness with and without clinical signs.

PURPOSE: To report demographics, wearing patterns, and symptoms from soft contact lens (SCL) wearers with significant SCL-related dryness symptoms with and without significant ocular signs of dryness. METHODS: In a multicenter, prospective observational clinical trial, symptomatic SCL wearers reported significant SCL-related dryness via self-administered questionnaire of frequency and intensity of dryness after a dry eye (DE) examination. DE etiology was assigned post hoc by an expert panel, and those with and without significant DE-related signs were analyzed by univariate logistic regression. Possible DE etiologies were aqueous tear deficiency, SCL-induced tear instability, meibomian gland dysfunction, or "other." Wearers without signs that qualified for any DE etiology were designated as No DE Signs (NDES). RESULTS: Of the 226 SCL symptomatic wearers examined, 23% were without signs, 30% had aqueous tear deficiency, 25% had SCL-induced tear instability, 14% had meibomian gland dysfunction, and 8% had "other" diagnoses. The NDES wearers had significantly longer pre-lens break-up time (9.8 vs. 6.6 s, p < 0.0001), better lens wetting (3.4 vs. 2.4 0 to 4 scale, p < 0.0001), lower levels of film deposits on lenses (0.45 vs. 0.92, 0 to 4 scale, p < 0.0001), and of most slit lamp signs. The NDES wearers were significantly more likely to be male (36% vs.19%, p = 0.013), were less likely to have deteriorating comfort during the day (81% vs. 97%, p = 0.001), reported longer average hours of comfortable wear (11 ± 3 vs. 9 ± 4 h, p = 0.014), had older contact lenses (18 ± 14 vs. 13 ± 12 days, p = 0.029), and greater intensity of photophobia early and late in the day (p = 0.043 and 0.021). CONCLUSIONS: Symptoms of dryness in SCL wearers stem from a variety of underlying causes. However, nearly one-quarter of these symptomatic SCL wearers appear to be free of signs of dryness. The effective management of CL-related dryness requires a comprehensive range of clinical assessments and the use of a diverse range of management strategies.

Comparative effect of lens care solutions on blink rate, ocular discomfort and visual performance.

PURPOSE: To help maintain clear vision and ocular surface health, eye blinks occur to distribute natural tears over the ocular surface, especially the corneal surface. Contact lens wearers may suffer from poor vision and dry eye symptoms due to difficulty in lens surface wetting and reduced tear production. Sustained viewing of a computer screen reduces eye blinks and exacerbates such difficulties. The present study evaluated the wetting effect of lens care solutions (LCSs) on blink rate, dry eye symptoms, and vision performance. METHODS: Sixty-five adult habitual soft contact lens wearers were recruited to adapt to different LCSs (Opti-free, ReNu, and ClearCare) in a cross-over design. Blink rate in pictorial viewing and reading (measured with an eyetracker), dry eye symptoms (measured with the Ocular Surface Disease Index questionnaire), and visual discrimination (identifying tumbling E) immediately before and after eye blinks were measured after 2 weeks of adaption to LCS. Repeated measures anova and mixed model ancova were conducted to evaluate effects of LCS on blink rate, symptom score, and discrimination accuracy. RESULTS: Opti-Free resulted in lower dry eye symptoms (p = 0.018) than ClearCare, and lower spontaneous blink rate (measured in picture viewing) than ClearCare (p = 0.014) and ReNu (p = 0.041). In reading, blink rate was higher for ClearCare compared to ReNu (p = 0.026) and control (p = 0.024). Visual discrimination time was longer for the control (daily disposable lens) than for Opti-Free (p = 0.007), ReNu (p = 0.009), and ClearCare (0.013) immediately before the blink. CONCLUSIONS: LCSs differently affected blink rate, subjective dry eye symptoms, and visual discrimination speed. Those with wetting agents led to significantly fewer eye blinks while affording better ocular comfort for contact lens wearers, compared to that without. LCSs with wetting agents also resulted in better visual performance compared to wearing daily disposable contact lenses. These presumably are because of improved tear film quality.

Dendritic immune cell densities in the central cornea associated with soft contact lens types and lens care solution types: a pilot study.

BACKGROUND: The purpose of this study was to assess whether differences in central corneal dendritic immune cell densities associated with combinations of soft contact lenses and lens care solutions could be detected by in vivo confocal microscopy. METHODS: Participants were adults naïve to contact lens wear (n = 10) or who wore soft contact lenses habitually on a daily-wear schedule (n = 38) or on a study-assigned schedule for 30 days with daily disposable silicone hydrogel lenses (n = 15). Central corneas were scanned using an in vivo confocal microscope. Cell densities were compared among groups by demographic parameters, lens materials, and lens care solutions (polyhexamethylene biguanide [PHMB], polyquaternium-1 and myristamidopropyl dimethylamine [PQ/MAPD], peroxide, or blister pack solution [for daily disposable lenses]). RESULTS: Among lens wearers, no associations were observed between immune cell densities and age, gender, or years of lens-wearing experience. Mean cell density was significantly lower (P < 0.01) in nonwearers (29 ± 23 cells/mm(2), n = 10) than in lens wearers (64 ± 71 cells/mm(2), n = 53). Mean cell density was lower (P = 0.21) with traditional polymer lenses (47 ± 44 cells/mm(2), n = 12) than with silicone hydrogel lenses (69 ± 77 cells/mm(2), n = 41). Lowest to highest mean density of immune cells among lens wearers was as follows: PQ/MAPD solution (49 ± 28 cells/mm(2)), blister pack solution (63 ± 81 cells/mm(2)), PHMB solution (66 ± 44 cells/mm(2)), and peroxide solution (85 ± 112 cells/mm(2)). CONCLUSION: In this pilot study, in vivo confocal microscopy was useful for detecting an elevated immune response associated with soft contact lenses, and for identifying lens-related and solution-related immune responses that merit further research.

Effects of fluorescein staining on laser in vivo confocal microscopy images of the cornea.

This study was designed to identify whether topical fluorescein, a common ophthalmic tool, affects laser in vivo confocal microscopy of the cornea, a tool with growing applications. Twenty-five eye care specialists were asked to identify presence or absence of fluorescein in 99 confocal micrographs of healthy corneas. Responses were statistically similar to guessing for the epithelium (48% ± 14% of respondents correct per image) and the subbasal nerve plexus (49% ± 11% correct), but results were less clear for the stroma. Dendritic immune cells were quantified in bilateral images from subjects who had been unilaterally stained with fluorescein. Density of dendritic immune cells was statistically similar between the unstained and contralateral stained eyes of 24 contact lens wearers (P = .72) and of 10 nonwearers (P = .53). Overall, the results indicated that fluorescein staining did not interfere with laser confocal microscopy of corneal epithelium, subbasal nerves, or dendritic immune cells.

Multicenter case-control study of the role of lens materials and care products on the development of corneal infiltrates.

PURPOSE: To evaluate the association of symptomatic soft contact lens (SCL)-related corneal infiltrative events (CIEs) with SCL material, lens care products (LCPs), and other risk factors. METHODS: Cases with symptomatic CIEs were identified in a retrospective, multicenter case-control study at five academic eye care centers. Each case was matched to three controls each who had received eye care near the time of the case's last full examination at that center but were not matched for demographic or other factors. Infiltrate status was established by an expert panel who were masked to sponsor, SCL, and LCP brand. Stratified analyses were conducted removing all daily disposable (DD) and all extended wear (EW) cases. RESULTS: Clinical records from 166 patients with symptomatic CIEs and known EW status were included. Cases used >50 SCL brands and >10 LCP brands. Increased risk in univariate analysis for LCP was not significant after adjustment for other factors. In the multivariate analysis of all cases, use of reusable SCLs (4.03×; 95% C.I. 1.12 to 14.67) and EW (3.98×; 2.32 to 6.84) increased risk and patient age (per year older) was protective (0.96×; 0.94 to 0.98). Among daily wear cases (n = 102 cases), use of reusable SCLs (12.46×; 1.54 to 100.62) and silicone hydrogel (SiHy) (1.99×; 1.06 to 3.75) and age (0.95×: 0.92 to 0.97) were associated. Without DD cases (n = 162), EW (4.42×; 2.53 to 7.70), SiHy use (1.84×; 1.03 to 3.29), and patient age (0.96× 0.94 to 0.98) were significant factors. No specific SCL or LCP brands were associated with increased risk. CONCLUSIONS: In this community-based trial, younger patients were at increased risk of infiltrative events. DD lenses were protective relative to reusable lenses. Overnight use increased risk in all analyses and silicone hydrogels increased risk in daily wearers, regardless of LCP brand. Improvements in lens storage case hygiene and environment may be a mechanism for reducing risk of CIEs related to SCL use.

Characterizing contact lens-related dryness symptoms in a cross-section of UK soft lens wearers.

PURPOSE: To estimate the prevalence of and factors associated with contact lens-related dryness symptoms in a large population of soft contact lens patients in the UK. METHODS: Soft contact lens (CL) wearers (n=932) from 12 UK clinical sites were queried regarding CL history and wearing experience by a self-administered questionnaire. A new score using Contact Lens Dry Eye Questionnaire (CLDEQ) items was used where CL-related dry eye (CL-DE)=frequency of 'sometimes', 'frequently', or 'constantly' plus intensity 3-5; NoCL-DE=frequency of 'never' or 'rarely' and intensity 0-1; Marginal CL-DE, all other categories. Data were analyzed across categories, P-values <0.05 significant. RESULTS: The prevalence of CL-DE was: CL-DE=31%, Marginal CL-DE=13% and NoCL-DE=56%. Wearers with CL-DE had significantly lower typical comfort (CL-DE=7.0 ± 1.9; Marginal=7.6 ± 1.9; NoCL-Dry=8.7 ± 1.8, P<0.001), end-of-day comfort (CL-DE=4.9 ± 2.5; Marginal=6.1 ± 2.0; NoCL-DE=7.8 ± 2.1, P<0.001) and shorter comfortable wearing times in hours (CL-DE=9.1 ± 4.4; Marginal=9.8 ± 3.6; NoCL-DE=12.4 ± 5.1, P<0.001). Positive CL-DE status was significantly more likely among toric lens wearers (n=129) compared to spherical lens wearers (43% vs. 30%, P=0.04). Lens material class, lens care system and gender were not significantly related to CL-DE status. Of the CL-DE group, only 38% had been diagnosed with dry eye and 47% self-assessed as dry eye. Use of artificial tears, CLs for dryness, ointments/gels and warm compresses differed between groups according to CL-DE status (P<0.001, all comparisons). CONCLUSIONS: The survey provided useful data regarding the current status symptoms among UK soft CL wearers. The CL-DE score predicted patients' wearing experience; poorer comfort, shorter comfortable wearing time and increased use of treatments.