Daytime Changes in Tear Film Parameters and Visual Acuity with New-Generation Daily Disposable Silicone Hydrogel Contact Lenses-A Double-Masked Study in Symptomatic Subjects.

This prospective, double-masked, contralateral study aimed to analyze and compare daytime changes in pre-lens tear film (PLTF) stability and optical quality in symptomatic subjects wearing two contact lenses (CL). A secondary goal was to assess the performance of the PLTF by using dynamic topography techniques and analyzing surface asymmetry and irregularity indexes (SAI and SRI, respectively). Measurements were conducted on 20 symptomatic subjects (OSDI score > 13). Participants were fitted contralaterally and randomly with spherical Delefilcon A and Stenfilcon A CLs and underwent a series of measurements over 3 consecutive days: three in the morning (after 1-2 h of CL wear) and three in the afternoon (after 7-9 h of CL wear). High- and low-contrast visual acuity (HCVA and LCVA, respectively), pre-lens NIBUT, and dynamic topography were assessed. The contralateral fit of the two lenses allowed a direct and better comparison between them since they were exposed to the same conditions during the day. Consequently, both lenses demonstrated similar performance in HCVA, LCVA, and PLTF stability, with no statistically significant differences between them, although some fluctuations were observed throughout the day. Dynamic topography proved sensitive in evaluating temporal changes in the PLTF. The SRI index showed greater sensitivity to topographic changes due to lacrimal destabilization, making it potentially valuable for evaluating dry eye patients.

Long Day Wear Experience with Water Surface Daily Disposable Contact Lenses.

Objective: The purpose of this study was to assess the wear experience of silicone hydrogel daily disposable contact lenses with water surface technology over a long day of lens wear. Methods: Thirty-five soft contact lens wearers were refit with the daily disposable study lenses and participants scored their initial impressions of comfort, vision and satisfaction using a visual analog scale (VAS). Participants used their smart phones to complete surveys of comfort and vision on a scale of 1-10 at 10, 12, 14, and 16 hours of lens wear on 5 weeknights. A participant score for each time point was calculated by averaging the evening responses. End of study VAS surveys of symptoms were also completed. Results: Median (Interquartile Range) VAS initial impression scores were 99.00 (12.00) for quality of vision, 98.00 (16.00) for comfort, and 100.00 (13.00) for satisfaction. The end of study surveys found end of day median VAS scores of 87.00 (19.00) for end of day quality of vision and 75.00 (24.50) for end of day comfort. The median score for overall quality of vision was 93.00 (14.00) and for overall comfort was 93.00 (16.50). The median score for end of day dryness was 37.00 (55.00) and overall dryness was 13.00 (34.00). Conclusion: The daily disposable lenses with water surface treatment used in this study maintained high median scores for comfort and quality of vision for up to 16 hours of wear.

Does placebo effect exist in contact lens discomfort management?

PURPOSE: To study the effect of daily disposable contact lens (DDCL) refitting in monthly contact lens (CL) wearers suffering from contact lens discomfort (CLD), and to assess if there is a placebo effect associated with this CLD intervention. METHODS: Symptomatic CL wearers, according to the Contact Lens Dry Eye Questionnaire 8 (CLDEQ-8 ≥ 12 points), were divided into two groups. The study group was provided with DDCLs (delefilcon A) and the control group with a masked pair of their habitual monthly CLs (placebo effect) and were assessed after one month. Then, the control group was provided with the same DDCLs and evaluated one month later. The symptoms were recorded with the CLDEQ-8 and global rating of change scale (GRCS). Non-invasive tear break-up time (NITBUT), conjunctival hyperaemia, fluorescein staining, and lid wiper epitheliopathy (LWE) were evaluated. Changes between visits, groups, and the effect of each intervention were analysed. RESULTS: Thirty-one participants (mean age: 23.2 ± 5.3 years) were recruited. The study group (n = 14) showed an improvement of -39.6 ± 25.8 % (p < 0.001) in CLDEQ-8 and 31.3 ± 14.6 points in GRCS (p < 0.001) after one month of DDCL use, while no changes in clinical tests were found. In the control group (n = 17), symptoms improved significantly after wearing the masked monthly CL (CLDEQ-8: -26.1 ± 31.0 %, p = 0.03; GRCS: 14.9 ± 17.0, p = 0.002), however a worsening in bulbar (26.5 ± 40.0 %; p = 0.02) and limbal hyperaemia (21.6 ± 34.7 %, p = 0.02) and an improvement of -19.1 ± 37.0 % (p = 0.049) in LWE was found. When the control group was fitted with the DDCL, improvements in GRCS (20.5 ± 25.5, p = 0.02), NITBUT (37.9 ± 42.3 %, p = 0.002), and conjunctival staining (-47.1 ± 59.9 %, p = 0.005) were noted. CONCLUSIONS: Refitting symptomatic monthly CL wearers with Delefilcon A DDCL is effective in reducing symptoms related to CLD. However, clinicians and researchers must be aware of the existence of a placebo effect when assessing the effectiveness of any CL refitting.

Daily Disposable Contact Lens use in Adolescents and its Short-term Impact on Self-Concept.

OBJECTIVE: To determine the short-term effect of contact lens (CL) wear on the self-concept of adolescents. METHODS: In this open-label trial, first-time CL wearing adolescents were prescribed Delefilcon A (DAILIES TOTAL1,® Alcon, USA) daily disposable CL. To determine the self-concept level of the subjects at dispensing and after one month, the Turkish adapted version of the Piers-Harris Children's Self-Concept Scale (PHCSCS) was used. The subject-reported outcomes included lens wettability, vision quality, comfort, and overall satisfaction. Self-concept was evaluated under six categories. RESULTS: The mean age of the 21 subjects was 16.5 ± 1.5 years. All subjects had normal biomicroscopic assessments and best corrected visual acuity was 20/20. The mean spherical equivalent was -2.90 ± 1.18 (range, -4.75 to -1.75). Spectacle use was causing dissatisfaction with their appearance in 90% of subjects (n = 19), the others defined it as uncomfortable. Most subjects had acquired information about CLs from their peers and friends (57%, n = 12). Most of the subscales in the PHCSCS showed increased but statistically insignificant scores after one month. The mean overall satisfaction was 95%. CONCLUSION: Prescription of CLs may be a good option in adolescents even if the self-concept did not show significant improvement in the short term.

Corneal epithelial thickness and corneal curvature changes during the day: The effects of daily disposable contact lens wear.

PURPOSE: To evaluate the changes in corneal epithelial thickness and corneal anterior and posterior curvatures during the day, and the effect of wearing daily disposable soft contact lenses. METHODS: Thirty-two healthy volunteers were enrolled in a randomized crossover study. At the baseline visit, corneal and epithelial thickness maps (OCT; Optovue, Inc., Fremont, CA, USA) and keratometric measurements (Pentacam, Oculus, GmbH, Germany) were performed in the morning and in the afternoon (8 hours after). Then, each subject was fitted with the following brands of daily disposable contact lenses in random order: Dailies Total 1 (Delefilcon A), Dailies Aqua Comfort (Nelfilcon A), TruEye (Narafilcon A) and Biotrue Oneday (Nesofilcon A) on different days. All fitted lenses had a power of -3.00 diopters (D). Measurements were repeated before putting the contact lens on and after an-eight-hour contact lens wear. RESULTS: With no lens wear, the anterior topographic indices showed significant steepening [Kflat: p < 0.0001; Ksteep: p < 0.0001 and maximum keratometry value (Kmax): p = 0.04] and the corneal thickness significantly decreased in the central and temporal portion of the cornea in the afternoon. There were no significant changes in the posterior topographical indices and corneal epithelial thickness. With contact lens wear, no significant change occurred in the corneal and epithelial thickness, and the anterior and posterior curvatures during the day (all p values >0.05). There was no statistically significant difference in the epithelial thickness among the groups wearing different contact lens types (p > 0.05). CONCLUSIONS: Anterior corneal topographic indices steepen depending on the natural diurnal variations. Daily wear of soft contact lenses appears to mask this steepening. The corneal epithelial thickness is not affected by daily disposable soft contact lenses.

Subjective Comparison of Pre-Lens Tear Film Stability of Daily Disposable Contact Lenses Using Ring Mire Projection.

PURPOSE: To subjectively evaluate the in vivo tear film stability of three daily disposable contact lenses (DDCLs) using placido ring reflection at lens wear times of 5 mins and 8 and 12 hrs. PATIENTS AND METHODS: This prospective, randomized, observer-masked, 3-way crossover study evaluated 28 subjects with good tear film stability. In vivo tear film stability was assessed for three DDCLs (nelfilcon A, etafilcon A, omafilcon A) on three different days over 12 hrs of lens wear. Time to first distortion by non-invasive keratography drying-up time (NIK-DUTf) was assessed by reviewing the captured videos. Lens wettability was also graded subjectively by three investigators using a scale from 0 (no visible distortions) to 3 (distortions in more than one-third of the ring reflection zone). Medians were analyzed statistically. RESULTS: Mean NIKDUTf at 8 hrs was longer for nelfilcon A and shorter for etafilcon A and omafilcon A, but the differences were not significant. NIK-DUTf did not differ significantly among nelfilcon A, etafilcon A and omafilcon A DDCLs at all visits (p=0.36). Subjective wettability grades after 5 mins, 8 hrs, and 12 hrs differed significantly for etafilcon A (P <0.01) and omafilcon A (p < 0.01), but not for nelfilcon A (p = 0.05), DDCLs. CONCLUSION: Grading was sufficiently sensitive to differentiate the wettability performances of the three lens materials. Nelfilcon A maintained wettability over the wearing period, whereas etafilcon A material showed faster dewetting at 8 and 12 hrs than at 5 mins after lens insertion.

Objective Analysis of Pre-Lens Tear Film Stability of Daily Disposable Contact Lenses Using Ring Mire Projection.

PURPOSE: The primary objective of this study was to evaluate the in vivo pre-lens non-invasive drying-up time of two types of daily disposable contact lenses (DDCLs) after 12 hours of wear. METHODS: This prospective, randomized, single-center, cross-over pilot study evaluated 31 subjects aged 18-44 years with normal eyes and good tear film stability who were adapted current soft contact lens wearers. Subjects wore nelfilcon A and stenfilcon A DDCLs for 12 hours each on two different days. Non-invasive video keratography drying-up time (NIK-DUT) videos of each eye were recorded 12 hours after lens insertion for about 25 seconds, with a 5-minute tear film recovery time allowed between video recordings of the right and left eyes to avoid bias. Post-blink time required to reach 15% distortion of the projected rings and the speed of break-up at 15 seconds post-blink were measured at each time point and on-eye wettability was determined by ring mire projection under white light illumination. RESULTS: Mean time to reach 15% ring distortion was similar for nelfilcon A (19.25±3.20 sec) and stenfilcon A (20.24±3.02 sec) DDCLs but varied highly among subjects. The mean speed of break-up at 15 sec post-blink was 0.3±0.38% distortion/sec (95% confidence interval [CI] 0.138-0.365% distortion/sec) for nelfilcon A and 0.2±0.23% distortion/sec (95% CI 0.048-0.279% distortion/sec) for stenfilcon A DDCLs. CONCLUSION: Multifunctional topography allowed the objective evaluation of in vivo pre-lens tear film stability using ring mire projection. This dynamic method was simple, fast and non-invasive, enabling measurements of NIK-DUT and evaluating wettability over a large area, greater than the optical zone of the contact lens surface, for the entire inter-blink interval.

Health beliefs affect the correct replacement of daily disposable contact lenses: Predicting compliance with the Health Belief Model and the Theory of Planned Behaviour.

PURPOSE: To assess the compliance of Daily Disposable Contact Lenses (DDCLs) wearers with replacing lenses at a manufacturer-recommended replacement frequency. To evaluate the ability of two different Health Behavioural Theories (HBT), The Health Belief Model (HBM) and The Theory of Planned Behaviour (TPB), in predicting compliance. METHOD: A multi-centre survey was conducted using a questionnaire completed anonymously by contact lens wearers during the purchase of DDCLs. RESULTS: Three hundred and fifty-four questionnaires were returned. The survey comprised 58.5% females and 41.5% males (mean age 34±12years). Twenty-three percent of respondents were non-compliant with manufacturer-recommended replacement frequency (re-using DDCLs at least once). The main reason for re-using DDCLs was "to save money" (35%). Predictions of compliance behaviour (past behaviour or future intentions) on the basis of the two HBT was investigated through logistic regression analysis: both TPB factors (subjective norms and perceived behavioural control) were significant (p<0.01); HBM was less predictive with only the severity (past behaviour and future intentions) and perceived benefit (only for past behaviour) as significant factors (p<0.05). CONCLUSIONS: Non-compliance with DDCLs replacement is widespread, affecting 1 out of 4 Italian wearers. Results from the TPB model show that the involvement of persons socially close to the wearers (subjective norms) and the improvement of the procedure of behavioural control of daily replacement (behavioural control) are of paramount importance in improving compliance. With reference to the HBM, it is important to warn DDCLs wearers of the severity of a contact-lens-related eye infection, and to underline the possibility of its prevention.

Assessment of corneal morphological changes induced by the use of daily disposable contact lenses.

PURPOSE: To assess the effect of different disposable soft contact lenses upon corneal thickness, and upon anterior and posterior corneal curvatures using a dual-Scheimpflug imaging based device. METHODS: Twenty-eight young, healthy subjects wore four different types of daily disposable soft contact lenses on four different days: Dailies Total1, Proclear 1 Day, Clariti 1-Day and 1-Day Acuvue Moist. The lenses had different material and water content. Pachymetry maps and keratometry values were obtained using the Galilei G4 twice a day: one before putting the lens on and one after an eight-hour period of contact-lens wear. Measurements were also recorded without any contact lenses being worn during a day. RESULTS: Clariti 1-Day lens caused the greatest thickening in the central (8.9±2.8 µm; p<0.01) and in the peripheral cornea (10.1±4.6 µm; p<0.01), whereas Dailies Total1 was the lens that had the most similar behaviour to the non-contact lens scenario. All the lenses caused a slight flattening in the anterior corneal curvature, except Clariti 1-Day, which induced a very slight steepening. The four lenses caused a steepening of different magnitude in the posterior corneal curvature. CONCLUSIONS: The magnitude of the changes introduced by the use of soft contact lenses over the eight-hour wearing period was rather small. Thus it is probable it will not influence the vision nor the comfort of the subject. Also, variations on corneal parameters seem to depend on the type of contact lens used.

Rates of adverse events with hydrogel and silicone hydrogel daily disposable lenses in a large postmarket surveillance registry: the TEMPO Registry.

PURPOSE: To report annualized adverse events (AEs) including corneal infiltrative events (CIEs) with use of silicone hydrogel (SiHyDD) and hydrogel daily disposable (HydDD) soft contact lenses (SCLs) in the 1•DAY ACUVUE TruEye or 1•DAY ACUVUE MOIST Performance Overview (TEMPO) Registry (NCT01467557). METHODS: Annualized incidence of symptomatic daily disposable (DD)-related AEs was calculated from 3064 surveys from 1171 subjects (601 SiHyDD and 570 HydDD, 31.8 ± 13.5 years, 68% female) during 1 year. Three independent experts adjudicated potential AE cases. Demographics were compared between wearers with and without AEs. RESULTS: The registry tracked 960.3 years of lens wear: SiHyDD 489.4 years and HydDD 470.9 years. In that period, the 601 SiHyDD wearers reported eight AEs with office visits (1.6%/y; 2 CIEs, 0.4%/y), eight (1.6%/y) without office visits, and four AEs unrelated to SCLs (0.8%/y) (SiHyDD wearers with AEs; 44.8 ± 12.5 years; 75% female). The 570 HyDD wearers reported three AEs with office visits (0.6%/y; no CIEs), five without office visits (1.1%/y), and one non-SCL-related AE (0.2%/y) (HydDD wearers with AEs; 26.3 ± 8.0 years; 100% female). These CIE rates are significantly lower than the lowest estimate of 3.3% from prior studies. Wearers with SiHyDD-related AEs were significantly older than unaffected wearers (P = 0.02), but not for HydDD-related AEs. CONCLUSIONS: The CIE rates of 0.4% and 0% with these DD lenses are significantly lower than rates reported with reusable SCLs (3%-4%/y), indicating improved safety outcomes with these DD lenses. Compared to unaffected wearers, SiHyDD lens wearers with AEs requiring clinical visits were significantly older. (ClinicalTrials.gov number, NCT01467557.).