Disposable Contact Lens Wear Research Articles

Defining Daily Disposable Contact Lens Wear in a Clinical Study.

The U.S. Food and Drug Administration regulates contact lenses as prescription medical devices and defines daily disposable lenses for single use; however, safety comparisons between daily disposable and reusable lenses rely on the lens-wearing regimen. When inappropriately discerned, studies may erroneously report replacement regimen, resulting in inaccurate risk rates. This study aimed to explore different measures for defining daily disposable wearers in the context of a clinical study. A secondary analysis of data from five multisite fieldings (n = 1059) from the Contact Lens Risk Survey was performed. Descriptive statistics were used to examine self-reported lens replacement, use of lens case, and manufacturer's recommended replacement frequency as defined by the participants' selection of their habitual lenses using a photographic aide. Daily disposable wearers were identified as reporting daily replacement (by self-report and lens identification) and not using a lens case. If there was a discrepancy among these three factors, the lens assignment was assessed as a majority response (two of three) or as missing if conflicting information was reported. The cohort was approximately two-thirds (68.7%) female and ranged from 12 to 33 years of age. A total of 154 participants (14.5%) were classified as daily disposable wearers and 896 (84.6%) as reusable wearers. Congruence was observed among all three daily disposable assignment factors for only 106 wearers (68.8%). The greatest discrepancy among daily disposable wearers was the report of using a lens case (n = 32 [20.8%]). In contrast, reusable lens wearers were more likely to report agreement across all three factors (n = 798 [89.1%], P < .001). This analysis suggests that the report of not using a lens case is a more conservative surrogate for true single-use lens wear, as one in five may be storing and reusing their daily disposable lenses.

Examining daily disposable soft contact lens wearers' attitudes and beliefs using the Health Belief Model.

To use the Health Belief Model (HBM) to understand daily disposable (DD) soft contact lens (SCL) wearers' attitudes and beliefs. A convenience sample of DD SCL wearers (18-33 years) was enrolled at two sites. Participants were queried about demographics, SCL wear and HBM constructs. Rasch analysis was used to assess the psychometric properties of the survey instrument and generate scores for each HBM subscale. ANOVA was used to determine relationships among HBM constructs, subject demographics and DD SCL-related health behaviours. One hundred people participated (mean ± SD), age=24.2 ± 3.9 years, 76% female. Thirty-seven percent reported sleeping in DD SCLs and 25% reported reusing DD SCLs. Self-report of reusing DD SCLs was associated with scores on the benefits: reuse (p=0.02) and barriers (p=0.007) subscales, and sleeping in lenses was associated with scores on the susceptibility (p=0.05), benefits: wear behaviours (p=0.006) and barriers (p=0.01) subscales. Rasch analysis showed some subscales demonstrated multidimensionality. Selected health belief constructs were associated with DD SCL-related behaviours including reusing and overnight wear. Increased understanding of SCL attitudes and beliefs could inform patient education and interventions to decrease risks associated with improper SCL wear.

Myopia Progression and Slit-Lamp Findings in Children: MiSight® 1 day clinical trial

Purpose: To evaluate myopia progression and slit-lamp findings in two demographically matched groups of children completing 6 years of daily disposable contact lens (DD CL) wear.

How does the optometry profession move up a gear to tackle the problem of climate change?

How does the optometry profession move up a gear to tackle the problem of climate change?

Natural course of lid wiper epitheliopathy (LWE) in symptomatic contact lens wearers

PurposeTo establish the time course of lid wiper epitheliopathy (LWE) in established CL wearers after a single day (6–10 h) of daily disposable contact lens (CL) wear, the following day post-CL removal and 1-week after CL discontinuation. MethodsTwenty-one symptomatic (CLDEQ-8 score ≥ 12) habitual wearers of MyDay® silicone hydrogel daily disposable were included. LWE staining was assessed prior to CL wear (Visit 1, V1) using semi-automated analysis after instillation of two drops of 1 % lissamine green (10 μL) that were applied to the superior bulbar conjunctiva. LWE measurements were repeated after 6–10 h of continuous CL wear (Visit 2, V2), post-CL removal the following day (Visit 3, V3) and after 1-week CL discontinuation (Visit 4, V4). At each visit, ocular symptoms were evaluated using the SPEED-8 questionnaire and set of 0–100 visual analogue scales (VAS). ResultsLWE showed no significant changes after 6–10 h of continuous CL wear (p = 0.536), post-CL removal the following day (p = 0.677) or following 1-week of CL discontinuation (p = 0.478). Analysis revealed a significant improvement in symptomatology between V1 and V2 (SPEED-8, p < 0.01) and also improvements in the 0–100 VAS scores between V2 and V4 for average daily dryness (p < 0.01), end-of-day dryness (p < 0.01) and frequency of end-of-day dryness (p < 0.05). ConclusionThe present data suggest that the etiology of LWE is multifactorial and the sole intervention of temporarily discontinuing CL wear does not lead to resolution of these clinical signs.

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.

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.

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.

Tear Film Characteristics During Wear of Daily Disposable Contact Lenses.

PurposeTo evaluate changes induced over time by three daily disposable (DD) contact lenses on tear meniscus height (TMH), pre-lens non-invasive break-up time (pre-lens NIBUT), tear film osmolarity (TO) and objective quality of vision (OQV).Patients and MethodsForty-six subjects enrolled in this prospective open-label unmasked non-randomized simultaneous comparative cross-over study. For the first week of the study, subjects wore a nesofilcon A lens in the right eye and a delefilcon A lens in the left eye. After 3 days of washout, for the second week, subjects wore a nesofilcon A lens in the left eye and a stenfilcon A lens in the right eye. TMH, pre-lens NIBUT, TO and OQV were measured before contact lens fitting and for each contact lens combination on day 1 at 20 minutes and on day 7 after ≥8 hours of wear. OQV measurement included the changes of objective scatter index (OSI), the stability index (SI) and the fluctuation index (FI) calculated in a range of time of 20 s from a blink.ResultsTMH was unchanged at 20 minutes wear of all lenses but was significantly reduced after 8 or more hours wear (on day 7) of delefilcon A and stenfilcon A, respectively. Pre-lens NIBUT was significantly reduced with all lenses, while no significant change in TO was observed with any lens. SI and FI increased significantly for all lenses at both wear times.ConclusionWhile the presence of any contact lens on the eye challenges the tear film, nesofilcon A contact lenses, despite their high water content, compared to delefilcon A and stenfilcon A contact lenses, showed a lower overall effect. We speculate that superior tear film behavior while wearing nesofilcon A lenses may translate to improved subjective comfort, but this remains to be evaluated.

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

PurposeTo 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. MethodsThirty-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. ResultsWith 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). ConclusionsAnterior 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.

Objective Evaluation Of On-Eye Optical Quality Of Daily Disposable Silicone Hydrogel Contact Lens With Internal Wetting Agents.

PurposeTo investigate the on-eye optical quality of a daily disposable silicone hydrogel contact lens with internal wetting agent.Patients and methodsStudy subjects were daily disposable soft contact lens wearers (N=20) who were instructed to wear daily disposable hydrogel etafilcon A lens (without added wetting agent) or daily disposable silicone hydrogel senofilcon A lens (with an internal wetting agent), for a week. Subjects wore their respective lenses bilaterally and disposed of the pair of lenses daily. At the end of the 1-week test-wear period, the on-eye visual performances of the lens and the ocular surfaces were evaluated. A wavefront sensor measured sequential ocular higher-order aberrations (HOAs) for 10 s after the blink. The aberration data were analyzed in the central 4-mm diameter up to the sixth-order Zernike polynomials. Total HOAs, fluctuation index (FI), and stability index (SI) of the total HOAs over time were compared between the two lenses. Ocular surface evaluation with fluorescein was performed following the wavefront measurement.ResultsThe senofilcon A lens had significantly lower average total HOAs, FI, and SI (p<0.001, p=0.001, p=0.007, respectively) than the etafilcon A lens. After 1-week wear of each lens, corneal staining was observed in eight subjects (40%) with the etafilcon A lens and in two subjects (10%) with the senofilcon A lens. The senofilcon A lens had significantly lower incidence of corneal staining than the etafilcon A lens (p=0.041).ConclusionQuantitative sequential measurement of HOAs objectively showed the possibility of better and more stable optical quality with silicone hydrogel daily disposable contact lens with the internal wetting agent than with hydrogel lens without the added wetting agent.

Refitting Daily Disposable Contact Lens Wearers With Dry Eye Disease With A Different Daily Disposable Lens Type

Refitting Daily Disposable Contact Lens Wearers With Dry Eye Disease With A Different Daily Disposable Lens Type

Tear film mucin composition during daily disposable contact lens wear

Tear film mucin composition during daily disposable contact lens wear

Tear film changes over a day of daily disposable contact lens wear

Tear film changes over a day of daily disposable contact lens wear

Preinflammatory Signs in Established Reusable and Disposable Contact Lens Wearers.

Established reusable contact lens (CL) wearers show higher tear inflammatory cytokine concentrations and greater conjunctival metaplasia in the region covered by standard soft CLs. The balance of proinflammatory to anti-inflammatory cytokines, but not individual tear cytokine concentrations, was associated with self-reported CL discomfort. Daily disposable (DD) lenses are often used to improve CL discomfort, but the effect on ocular inflammatory responses has not been fully investigated. This study aimed to compare the concentrations of tear cytokines and conjunctival cell morphology in healthy habitual DD and reusable soft CL wearers. Thirty-six established daily CL wearers, including 14 DD and 24 reusable wearers, were enrolled. Symptoms and ocular surface integrity were evaluated. The concentration of tear cytokines (interleukin 1β [IL-1β], IL-6, IL-10, IL-12(p70), IL-17A, and tumor necrosis factor α) were determined using Multiplex assays. The ratios of proinflammatory and anti-inflammatory cytokines were calculated. Impression cytology was performed on the conjunctiva, and goblet cell density and epithelial squamous metaplasia were quantified. Differences in variables by CL replacement schedules and the associations between variables were analyzed. Reusable CL wearers had higher concentrations (in pg/mL) of IL-1β (26 ± 7 vs. 16 ± 11), IL-6 (42 ± 14 vs. 25 ± 20), IL-10 (83 ± 23 vs. 49 ± 36), IL-12(p70) (145 ± 44 vs. 91 ± 68), IL-17A (93 ± 26 vs. 54 ± 44), and tumor necrosis factor α (312 [171 to 468] vs. 189 [6 to 447]) (all P < .01) and greater conjunctival metaplasia in the region covered by CLs (0.7 [0.2 to 1.6] vs. 0.4 [0.04 to 1.2], P = .01) compared with DD wearers. There was a positive association between CL discomfort and ratios of IL-1β to IL-10 and IL-12(p70) to IL-10 (ρ = 0.42 and ρ = 0.33, P < .05). Higher ocular inflammatory responses, as indicated by higher tear cytokine concentrations and higher conjunctival epithelial metaplasia, were found in reusable CL wearers than in DD CL wearers. The balance of proinflammatory and anti-inflammatory cytokines may be helpful to assess the inflammatory status of the eye.

The impact of daily disposable soft contact lens wear on tear film surface quality over a three month period

PurposeTo study the changes in Tear Film Surface Quality (TFSQ) on a Silicon Hydrogel (SiHy) and a Hydrogel (Hy) daily contact lens (CL), during a follow‐up period of three months.MethodsForty‐six subjects aged 25.5 ± 4.3 (mean ± standard deviation) years with a refractive error limited to ±4.50 spherical and ±0.75 cylindrical dioptres were recruited. Based on a pre‐clinical analysis which took into account visual acuity (VA), comfort, and fitting, 31 subjects were fitted with SiHy and 13 with Hy lenses. TFSQ was studied based on measurements of the first and the mean non‐invasive keratography tear break up time (F/M–NIKBUT). All measurements were acquired at baseline, post four hours (4 h) and three months (3 m) of CL lens wear. Ocular Surface Disease Index (OSDI) questionnaire was also completed.ResultsThe results of the OSDI questionnaire showed an average improvement of 3.09 and 4.16 units for 3 m visit for SiHy and Hy lens, respectively. Nevertheless, this improvement was not statistically significant (p = 0.144 and p = 0.215). For F‐NIKBUT, there was no significant difference between 4h and 3m measurements (p=0.490 and p = 0.588 for SiHy and Hy lens, respectively). For M‐NIKBUT, there was no significant difference for SiHy and Hy groups between baseline and 4 h (p = 0.052 and p = 0.110, respectively). However, there was a significant difference between baseline and 3 m for SiHy group (p = 0.009) but not for the Hy group (p = 0.376). Lastly, no significant differences were observed between 4 h and 3 m M‐NIKBUT measurements for both lenses (p = 0.746 and p = 0.273 for SiHy and Hy lens, respectively).ConclusionsThe results indicate that estimates of 4 h of lens wear NIKBUT can be used to predict those at a 3 m visit. Also, Hy lens appeared to have less impact on TFSQ than the SiHy lens.

Risk factors and causative organisms in microbial keratitis in daily disposable contact lens wear.

PurposeThis study investigated independent risk factors and causative organisms in microbial keratitis in daily disposable contact lens (CL)-wearers.MethodsA multisite prospective case-control study was undertaken. Cases were daily disposable CL-wearers attending Moorfields Eye Hospital with microbial keratitis and those reported through a one-year surveillance study in Australia and in New Zealand. A population-based telephone survey identified daily disposable CL-wearing controls. Subjects completed a questionnaire describing CL-wear history, hygiene and demographics. The sample used for risk factor analysis was weighted in proportion to the CL-wearing population at each location. Corneal scrape results were accessed. Independent risk factors were determined using multiple binary logistic regression. Causative organisms in different CL-wear modalities were compared using a chi-squared test.Results963 daily disposable CL-wearers were identified, from which 67 cases and 374 controls were sampled. Independent risk factors were; wearing CLs every day compared with less frequent use (OR 10.4x; 95% CI 2.9–56.4), any overnight wear (OR 1.8x; 95% CI 1.6–2.1), less frequent hand washing (OR 1.8x; 95% CI 1.6–2.0), and smoking (OR 1.3x; 95% CI 1.1–1.6). Certain daily disposable CLs (OR 0.2x; 95% CI 0.1–0.2) had protective effects. Environmental organisms were less frequently recovered with daily disposable CLs (20%), compared with other modalities (36%; p<0.02).ConclusionOvernight wear, increased exposure in daily wear, smoking and poor hand hygiene are significant risk factors for microbial keratitis with daily disposable CLs. Risk varied with daily disposable CL type. The profile of causative organisms is consistent with less severe disease.

Risk of Developing Complications among Contact Lens Wearers in Northern Border Region, Saudi Arabia. A Retrospective Cohort Study.

The present study aims towards investigating the risk of developing complications upon usage of different types of contact lens as well as the role played by different variables related to contact lens usage (replacement time, regular follow-up, etc). This is a retrospective cohort study. The total study sample (n = 143) were recruited from Rafha General Hospital, Northern Border Region, Saudi Arabia. All their data were collected and analyzed using chi square test. A &lt;em&gt;P-Value&lt;/em&gt; of&lt;em&gt; &amp;lt;&lt;/em&gt;0.05 was considered statistically significant. Reusable contact lens wearers were noted to have significantly more complications than disposable contact lens wearers (P&lt;em&gt;&amp;lt;&lt;/em&gt;0.05). The majority of the sample was reported to use contact lens for cosmetic (decorative) purpose than for therapeutic or optical indications (&lt;em&gt;63%&lt;/em&gt;). Regular follow-up was significantly associated with decrease incidence of contact lens complications (P&lt;em&gt;&amp;lt;&lt;/em&gt;0.01). Handling of reusable contact lenses must be done with care as complications are more likely to occur by using them than daily disposable contact lenses. Moreover, contact lens wearers must be advised about the importance of frequent replacement and regular follow-up as it showed significant decrease in complications. We can conclude from our finding that cosmetic usage of reusable contact lenses without proper handling and cleaning system is not advisable.

Bilateral simultaneous infective keratitis

To analyze the demographics, risk factors, clinical and microbiological characteristics of cases of bilateral simultaneous infective keratitis. In this retrospective case series, patients with clinical evidence of bilateral simultaneous infective keratitis were identified from January 1, 2011 to August 31, 2016. Demographics, risk factors, clinical and microbiological characteristics, and treatment outcomes were analyzed. Five patients (ten eyes) with bilateral simultaneous infective keratitis were identified. The mean age was 32.8 years (SD,±8.8; range, 24-44). All the patients were disposable soft contact lens wearers before presentation. The average size of the infiltrate was 4.76mm2 (SD±9.0; range, 0.2-31.34). A total of 4 types of bacteria were isolated, with Pseudomonas aeruginosa being the most frequently isolated bacteria involving 5 eyes of four patients. Infection resolved with medical treatment in 9 eyes, 1 patient required therapeutic corneal transplantation for impending corneal perforation. The average time taken for infection to resolve was 6.7days (SD±4.5; range, 2-16). In this case series, the most common risk factor of bilateral simultaneous microbial keratitis was use of soft disposable contact lens and the most commonly isolated bacteria was Pseudomonas aeruginosa. Bilateral simultaneous infective keratitis is uncommon and is a serious complication of contact lens use in immunocompetent adult patients.

Longitudinal changes in Langerhans cell density of the cornea and conjunctiva in contact lens‐induced dry eye

BackgroundThe aim was to determine longitudinal changes in Langerhans cell density (LCD) in the human cornea and conjunctiva during asymptomatic and symptomatic contact lens wear.MethodsTwenty‐five participants with contact lens‐induced dry eye (CLIDE) and 35 without CLIDE (NO‐CLIDE), diagnosed using a range of symptom questionnaires and objective tests (tear film break up, cotton thread tear test and corneal staining) were enrolled. The central cornea and nasal bulbar conjunctiva were examined using a Heidelberg laser scanning confocal microscope at baseline and following one, four and 24 weeks wear of daily disposable hydrogel contact lenses. Twenty‐three non‐contact lens‐wearing controls were also examined. Langerhans cells were counted manually from randomly selected images.ResultsIn the cornea, mean and standard error of the mean LCD was greater after one week of lens wear in CLIDE (55 ± 7 cells/mm2) versus NO‐CLIDE (43 ± 4 cells/mm2) (p = 0.041) and controls (27 ± 4 cells/mm2) (p < 0.001). LCD was also greater in NO‐CLIDE versus controls (p = 0.010). At week 4, LCD was greater in CLIDE (41 ± 6 cells/mm2) versus controls (27 ± 4 cells/mm2) (p = 0.004). There were no other significant differences between groups at weeks four or 24. In the conjunctiva, LCD was greater after one week of lens wear in CLIDE (17 ± 1 cells/mm2) (p = 0.003) and NO‐CLIDE (17 ± 3 cells/mm2) (p = 0.001) versus controls (7 ± 1 cells/mm2). There were no significant differences between groups at weeks four or 24.ConclusionsThe initial transient increase in corneal and conjunctival LCD in CLIDE (versus NO‐CLIDE) suggests an inflammatory component in the aetiology of this condition.