Daily Disposable Contact Research Articles

Lysozyme Deposition on Contact Lenses in an In Vitro Blink-Simulation Eye Model Versus a Static Vial Deposition Model.

To evaluate active lysozyme deposition on daily disposable (DD) contact lenses (CL) using a novel in vitro blink model. Three conventional hydrogel DD CL materials (etafilcon A, omafilcon A, nelfilcon A) and three silicone hydrogel DD CL materials (delefilcon A, senofilcon A, somofilcon A) were tested. The device blink rate was set to 6 blinks/min with a tear flow rate of 1 μL/min using an artificial tear solution (ATS) containing lysozyme and other typical tear film components. After incubation at 2, 4, or 8 hr, lenses were removed, and lysozyme activity was measured. A separate experiment was conducted with lenses incubated in a static vial containing 480 μL of ATS. Etafilcon A deposited significantly higher amounts of active lysozyme (402±102 μg/lens) than other lens materials after 8 hr (P<0.0001). Etafilcon A had a higher amount of active lysozyme using the blink model compared with the static vial (P=0.0435), whereas somofilcon A (P=0.0076) and senofilcon A (P=0.0019) had a higher amount of lysozyme activity in the vial compared with the blink model. The blink model can be tuned to provide quantitative data that closely mimics ex vivo studies and can be used to model deposition of lysozyme on CL materials.

An investigation into disposal and recycling options for daily disposable and monthly replacement soft contact lens modalities

PurposeTo examine the annualised waste and end-of-life disposal options with two representative soft contact lens (CL) modalities. MethodsThe component parts of two representative soft CL modalities were catalogued, separated, weighed and inspected for material identification: somofilcon A soft CLs (clariti elite, CooperVision Inc.) used with multi-purpose solution (MPS) (All in one Light, CooperVision Inc.) and somofilcon A CLs (clariti 1 day, CooperVision Inc). Using a model that assumed compliant wear and care of CLs, the mass of material solid waste generated by CL use over a year was calculated. Disposal options were explored using household and specialist recycling streams in order to develop recommendations for responsible disposal of CL waste. ResultsFull-time daily disposable (DD) CL wear generates 1.06 kg of waste annually compared to 0.83 kg generated by reusable-monthly replacement daily wear (‘reusable’) CLs. Plastic was the dominant material in both modalities. With full-time use of DD CLs, 64% of waste by mass was plastic blister trays. For full-time use of reusable CLs, where figures from lens and MPS packaging are combined, plastics accounted for 67% of waste by mass. MPS bottles alone made up almost half the waste (45%) associated with full-time reusable CL wear. ConclusionFull-time DD wear generates 27% more waste annually than full-time reusable lens wear. Reusable CL wearers can recycle 78% of waste at home. DD lens wearers have access to recycling options that allow them to recycle 100% of CL related waste. Full-time CL lens wear represents just 0.20–0.26% of the 412 kg of household waste generated per person, per year in the United Kingdom. Worn CLs should never be disposed of down the sink or lavatory. CL wearers should be aware of responsible end-of-life recycling and disposal options for all CL waste.

Ocular health of children wearing daily disposable contact lenses over a 6-year period

PurposeTo report on the ocular health and safety of children fit with soft hydrogel daily-disposable contact lenses, and followed for 6-years in a double-masked clinical trial investigating the performance of a dual-focus contact lens designed to control myopia progression. MethodsChildren aged 8−12 years, naïve to contact lens wear, were enrolled across four international sites. During years 1–3, children were randomised to either MiSight® 1 day or Proclear® 1 day (both omafilcon A, CooperVision, Inc.). The lenses were identical in material and geometry except for the front optical zone design. At the end of year-3, all those wearing Proclear 1 day were switched to MiSight 1 day, therefore all wore MiSight 1 day in years 4−6. Subjects agreed to wear the lenses at least 10-hours/day, 6-days/week. After dispensing, study visits were at 1-week, 1-month, 6-months and every 6-months until 6-years. At each visit, ocular measurements and subjective responses were recorded. Biomicroscopy used 0–4 grading scales; grade 0 represented no findings. Results144 children were enrolled: 69F:75M; mean age 10.1 years; mean cycloplegic spherical-equivalent refraction -2.11D; ethnicities included 34 East-Asian, 12 West-Asian, and 79 Caucasian. 92 completed the 6-years. Only three subjects discontinued due to an ocular adverse event (AE). No contact lens related AEs were classified as serious. The incidence rate of infiltrative AEs was 0.61% (6.1/1000 wearing-years; 95%CI: 0.24%–1.57%). The most common biomicroscopy findings were limbal, bulbar and tarsal hyperaemia and tarsal roughness. 99% of all biomicroscopy findings were grade-1 or lower. After 6-years of lens wear, ocular health by biomicroscopy was similar to pre-lens wear. ConclusionsAcross the 6-years, there were no contact lens related serious AEs and biomicroscopy showed no significant changes. Results suggest that children this age can successfully wear daily-disposable hydrogel contact lenses with minimal impact on ocular physiology.

5 years of daily disposable contact lens wear in children

Purpose: To report on the ocular health data and safety profile of soft hydrogel daily disposable contact lenses when fitted to children and worn during the first five years of an ongoing clinical trial of a dual-focus contact lens designed to control myopia progression.

Clinical lens fit characteristics of a new daily disposable toric silicone hydrogel contact lens

Clinical lens fit characteristics of a new daily disposable toric silicone hydrogel contact lens

Assessing the clinical performance of a new daily disposable silicone hydrogel contact lens

Purpose: To assess the clinical performance of a new daily disposable (DD), silicone hydrogel contact lens made from verofilcon A material.

Association between initial subjective ratings and overall lens acceptance in daily disposable contact lens wear

Purpose: Patients’ experiences with first attempts at trying contact lenses may influence the overall acceptance of lenses and ultimately the success of new fits. The purpose of this study was to determine if initial subjective patient experiences influence the overall acceptance of daily disposable lenses at the dispensing visit.

Characterizing the surface properties of daily disposable contact lens materials

Purpose: Using surface chemistry, a daily disposable silicone hydrogel (SiHy) contact lens with unique surface properties (verofilcon A) was developed. This novel lens material with “SMARTSURFACE” technology should provide a more wettable surface than other SiHy lens materials. This study used an in vitro model to characterize the aqueous film stability of this lens and compared with other commercial contact lenses.

Comparison of the clinical performance of a novel silicone hydrogel and a HEMA-based daily disposable contact lens

Purpose: Verofilcon A is a novel, daily disposable, silicone hydrogel contact lens with “SmartSurface” chemistry. The objective of this study was to assess overall lens preference, as well as overall comfort, handling and quality of vision of verofilcon A compared to a commercially available HEMA-based daily disposable lens (etafilcon A).

Non-invasive tear break-up time on six types of daily disposable contact lenses after 10 hours of wear

Purpose: Maintaining a persistent tear film over the surface of a contact lens is an important factor for successful contact lens wear. The chemistry of the lens material can play an important role in stabilizing tears. This study aims to evaluate the Non-invasive tear break up time (NIBUT) of 6 types of daily disposable contact lenses commonly available in the market after 10 h of wear.

Клинические примеры эффективности коррекции астигматизма слабой степени в нормализации зрительных функций

In today’s world, the extensive visual load increases the demands on the quality of optical correction. Inadequate optical correction results in additional load on the accommodation system of the eye, increased fatigue, and complaints of asthenopia. Full optical correction is an essential requirement for the correct functioning of a visual analyzer. However, if baseline impairments of accommodation response (fusion) are not considered, full optical correction (eyeglasses or contact lenses) provokes visual discomfort. Daily disposable contact lenses (CL) with power change for each additional month is helpful in these cases, thereby allowing for a stepwise transition to the complete correction of ametropias and recovery of physiological accommodation, convergence, and better central and binocular vision quality. Prescription of spherical (not toric) CL, whose optical power was calculated by the spherical equivalent of sphero-cylindrical correction, is a typical error when correcting low astigmatism. This error negatively affects accommodative response and visual working capacity. A complete correction of astigmatism (even a low one) is required for visual recovery to reduce visual fatigue and improve working capacity and academic performance. When prescribing optical correction, binocular vision patterns and a dominant eye should be considered. Keywords: astigmatism, accommodation, binocular vision, visual discomfort, asthenopia, toric soft contact lenses. For citation: Lobanova I.V., Rybakova E.G., Romanova T.B. Clinical examples of the effective correction of low astigmatism for improving vision. Russian Journal of Clinical Ophthalmology. 2021;21(4):249–252 (in Russ.). DOI: 10.32364/2311-7729-2021-21-4-249-252.

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

ObjectiveTo determine the short-term effect of contact lens (CL) wear on the self-concept of adolescents. MethodsIn 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. ResultsThe 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%. ConclusionPrescription of CLs may be a good option in adolescents even if the self-concept did not show significant improvement in the short term.

A 3-year Randomized Clinical Trial of MiSight Lenses for Slowing Myopia Progression

Significance. Results of this randomized, double-masked clinical trial demonstrate the effectiveness of the MiSight soft contact lens in slowing myopia progression over multiple years.Purpose. The purpose of this study was to quantify the effectiveness of MiSight daily disposable soft contact lens in slowing the progression of juvenile-onset myopia.Methods. Myopic children (spherical equivalent refraction, −0.75 to −4.00 D; astigmatism, &lt; 1.00 D) aged 8 to 12 years with no prior contact lens experience were enrolled in a 3-year, double-masked, randomized clinical trial at four investigational sites in four countries. Subjects in each group were matched for age, sex, and ethnicity and were randomized to either a MiSight®1 day contact lens (test) or Proclear®1 day (control; omafilcon A) and worn on a daily disposable basis. Primary outcome measures were the change in cycloplegic spherical equivalent refraction and axial length.Results. Of the subjects enrolled, 75.5% (109/144) completed the clinical trial (53 test, 56 control). Unadjusted change in spherical equivalent refraction was −0.73 D (59%) less in the test group than in the control group (−0.51 ± 0.64 vs. –1.24 ± 0.61 D, P &lt; 0.001). Mean change in axial length was 0.32 mm (52%) less in the test group than in the control group (0.30 ± 0.27 vs. 0.62 ± 0.30 mm, P &lt; 0.001). Changes in spherical equivalent refraction and axial length were highly correlated (r = −0.90, P &lt; .001). Over the course of the study, there were no cases of serious ocular adverse events reported. Four asymptomatic corneal infiltrative (one test, three control) events were observed at scheduled study visits.Conclusions. Results of this clinical trial demonstrate the effectiveness of the MiSight daily disposable soft contact lens in slowing change in spherical equivalent refraction and axial length.

Clinical Performance of a Novel Daily Disposable Soft Contact Lens

Background and Objective: Verofilcon A (PRECISION1®; Alcon) silicone hydrogel daily disposable contact lenses were designed to address clinical issues associated with new wearer discontinuation, including vision quality, sustained comfort, and ease of handling. The present study assessed the objective and subjective performance of verofilcon A contact lenses in subjects needing optical correction for refractive ametropia.&#x0D; Material and Methods: Subjects aged 18 years and older with non-diseased eyes, a history of successful soft contact lens wear for distance correction in both eyes during the previous 3 months, and a best spectacle-corrected visual acuity of 20/25 or better with a manifest cylinder of ≤ 0.75 diopters in each eye were recruited. The primary endpoint was distance visual acuity. Secondary endpoints included subjective ratings of overall vision, comfort, and handling, and safety endpoints included adverse events and biomicroscopy/slit lamp examination findings.&#x0D; Results: This study recruited 70 subjects (140 eyes), aged 20–48 years, who were predominantly white (93%), non-Hispanic/Latino (94%), and female (73%); one subject discontinued due to a change in residence. Of the 140 eyes, 132 (94.3%) had 20/20 or better vision with their habitual contact lenses. Similarly, of the 138 eyes that completed the study, 136 (98.6%) had 20/20 or better vision at dispensation of verofilcon A lenses and 132 (95.7%) had 20/20 or better vision at 3 months. Mean ± SD subjective ratings of overall vision, overall comfort, and overall handling, each on a 10-point scale, were 9.4 ± 0.8, 9.4 ± 0.8, and 9.2 ± 1.3, respectively, at lens dispensing, and 9.4 ± 0.9, 9.5 ± 0.8, and 9.2 ± 1.0, respectively, at 3 months. Mean ± SD daily wear times at 1 week and 3 months were 14.71 ± 1.85 and 15.05 ± 1.27 hours, respectively, with 68.1% at 1 week and 73.9% at 3 months wearing verofilcon A lenses for 14–18 hours per day. None of the subjects experienced a serious adverse event or discontinued lens wear, with biomicroscopy/slit lamp examination showing no evidence of corneal edema or chemosis.&#x0D; Conclusion: Subjects wearing verofilcon A lenses had visual acuity similar to that when wearing their habitual lens. Verofilcon A lenses were highly rated for vision quality, comfort, and handling. Verofilcon A lenses may be an option for subjects with refractive ametropia who desire lenses that can be worn for &gt;14 hours per day and are easy to handle.

The association of comfort and vision in soft toric contact lens wear

PurposeThis work set out to investigate if there was an association between subjective comfort and both subjective and measured vision during the use of contemporary daily disposable soft toric contact lenses. MethodsThirty-eight habitual soft contact lens wearers wore each of three daily disposable toric lenses for one week in a prospective, crossover, randomised, single-masked study. The following clinical measures were recorded at dispensing and follow-up visits: biomicroscopy scores, lens fitting (including rotation and rotational stability), high and low contrast visual acuity, subjective vision quality and subjective ocular surface comfort. Subjective scores were collected using 0–10 numerical grading scales. Comfort scores were analysed using a linear regression model with age, sex, visit, phase of crossover (‘phase’), lens type, lens rotation, lens rotational stability, visual acuity, cylinder power and subjective vision quality as factors of interest and then refined using backward stepwise regression. ResultsThirty six participants (31.1 ± 13.5 years) completed the study. Comfort scores were found to be associated with subjective vision quality (F = 127.0 ; p < 0.0001), phase (F = 7.2; p = 0.001) and lens type (F = 4.9; p = 0.009). Greater comfort scores were observed with greater subjective vision quality scores. Visual acuity was not statistically significant in the model. ConclusionThis work suggests that symptoms of ocular discomfort may be more intense if there is also perceived visual compromise in daily disposable soft toric lenses. There was a stronger positive correlation between comfort and subjective vision quality compared with comfort and measured visual acuity.

The Need for Ocular Protection for Health Care Workers During SARS-CoV-2 Outbreak and a Hypothesis for a Potential Personal Protective Equipment.

SARS-CoV-2 is a coronavirus with high infectivity and has caused dramatic pressure on health systems all over the world. Appropriate personal protection for medical staffs is critical. For ocular protection, there is ongoing hot debate and concern for potential ocular transmission of SARS-CoV-2. Ocular manifestations and positive detection of viral RNA in ocular samples were only reported in very small number of patients infected with SARS-CoV-2. However, health care workers need to face patients more closely and have higher risk of aerosol contamination. Thus, appropriate ocular protection for medical workers is still recommended by organizations such as WHO and American Academy of Ophthalmology. Although eye goggles provide excellent protection and are mandatory for medical practitioners with high risk of exposure, they are not ideal for common clinical practice, because they can disturb vision due to extensive formation of water droplets and frequently cause moderate to severe discomfort after longtime wearing, which have been reported to interfere with working status. For the majority of medical workers who don't deal with high risk patients, they are not advised to wear goggles in daily practice. However, they also face the risk of infection due to the presence of asymptomatic carriers. Especially in situations with high risk of ocular exposure, such as close physical examination, eye surgery, dental clinics and surgery, ocular protection may be needed. Griffithsin has been shown to directly bind to spike proteins and has anti-viral activity against a broad spectrum of viruses, including coronavirus. Griffithsin is found to inhibit the entry of SARS-CoV at relatively low concentration and is stable and non-toxic. SARS-CoV-2 and SARS-CoV share the same entry receptors and their spike proteins are similar in conformation. We hypothesize that contact lenses containing nanoparticles loaded with griffithsin may provide sufficient ocular protection for medical staffs without high risk of exposure during the outbreak period of SARS-CoV-2. If proven effective, griffithsin-loaded contact lens can be considered as a supplementary ocular protective equipment for medical workers who can tolerate well. The daily disposable contact lens should be applied as needed and refrain from extended wearing in order to reduce potential side effects.

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

PurposeThe 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.MethodsThis 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.ResultsMean 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.ConclusionMultifunctional 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.

In-vitro dewetting properties of planned replacement and daily disposable silicone hydrogel contact lenses

AimTo compare the in-vitro videokeratoscopic surface dewetting properties of new-generation silicone hydrogel (SiH) planned replacement contact lenses (CL) with those of daily disposable CLs. MethodA chrome coated cornea model was used for the in-vitro evaluation of surface dewetting. Pre-lens and post-lens film layers were formed by instilling a normal preservative-free normal saline solution (PFNs) (0.9 %) before and after the placement of the CL on the model cornea. The tests were carried out on fanfilcon A, lotrafilcon B, samfilcon A, and senofilcon A lenses, as well as such daily disposable lenses as delefilcon, nesofilcon A and senofilcon one day. Using videokeratoscopic methods, images were obtained at 30-second intervals up to 180 s in the lens and control groups and were analyzed by the ImajeJ® program. ResultsThe mean measured area of the keratoscopic rings was largest in the fanfilcon group (67.56 mm2), followed by 61.53 mm2 in the lotrafilcon A group and 64.60 mm2 in the samfilcon group, while the smallest area was measured in the senofilcon A group, at 56.90 mm2. The area was measured as 64.33, 63.09 and 68.39 mm2 for the delefilcon, nesofilcon and Senofilcon one day CLs, respectively. The dewetting patterns and properties differed in the CL groups (p < 0.05), while no significant differences were found between the measured areas of the planned replacement and daily disposable CL groups (p > 0.05). DiscussionVideokeratoscopy using in-vitro cornea models has been identified as a reproducible and reliable method for the analysis of the surface dewetting of CLs. The dewetting characteristics of CL groups have been found to differ from each other, despite all being produced from SiH materials. The surface wetting coating has been shown to affect CL dewetting performance.

Does placebo effect exist in contact lens discomfort management?

PurposeTo 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. MethodsSymptomatic 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. ResultsThirty-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. ConclusionsRefitting 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.

Meibomian glands structure in daily disposable soft contact lens wearers: a one-year follow-up study.

To assess the impact of daily disposable soft contact lenses on meibomian gland morphology over a period of 12months. Forty-one subjects (33 experienced and 8 neophytes) were fitted with either silicone-hydrogel or hydrogel daily contact lenses. The study protocol included four visits: baseline, day-2 for contact lens fit and follow-up measurements, as well as after 6 and 12months of lens wear. Non-contact infrared meibography images were acquired with Keratograph 5M topographer (www.oculus.de) and analysed with an automated method, which objectively estimates the area of gland atrophy, gland length and width, number of glands and gland irregularity. Protocol at follow-up visits also included symptom assessment with the Ocular Surface Disease Index and clinical assessment of tear meniscus height, bulbar and limbal redness, tear osmolarity, non-invasive fluorescein break-up time and ocular surface staining. Statistically significant differences were found in gland atrophy (p=0.02) and length (p=0.008) between experienced and novel contact lens wearers at the baseline visit. Changes over time (after 6 and 12months) were found in gland atrophy (p=0.02) and the number of glands (p=0.01) in subjects fitted with hydrogel contact lenses. Changes in gland atrophy between baseline and 12months of lens wear correlated with changes in corneal staining (r=0.40, p=0.03) and fluorescein break-up time in subjects fitted with silicone-hydrogel lenses (r=1-0.43, p=0.02). Contact lens wear impacts meibomian gland morphology. However, changes are either long-term or characteristic to an early phase. Subjects with no history of contact lens wear exhibit better meibomian gland condition than experienced wearers. During one year of contact lens wear, meibomian gland morphology changes in subjects wearing daily disposable hydrogel lenses.