Evaluating the Performance of Verofilcon A Daily Disposable Contact Lenses in a Group of Heavy Digital Device Users.

Purpose: The purpose of this study was to evaluate the performance of verofilcon A daily disposable contact lenses (CL) in CL wearers who identified themselves as heavy digital device users. Patients and Methods: This prospective, non-masked, open-label study enrolled CL wearers who reported ≥6 hours digital device use per day. Participants were dispensed with the verofilcon A study lenses for 14±2 days, to be worn for at least 5 days a week and 10 hours per day, while continuing their normal routine of digital device use. Participants rated the lens performance at the Day 14 visit using a 0-100 (with 100 being best) scale. Ratings were completed at lens insertion, after 6 hours of digital device use, just before CL removal and for overall experience. Participants also completed a 4-point (strongly agree/disagree, slightly agree/disagree) Likert scale-based questionnaire. Results: Thirty-two participants were eligible and completed the study (27 females; age 25.8 ± 6.0 years, ranging from 19 to 40). Overall lens performance ratings at the Day 14 visit (mean ± standard deviation) for comfort, dryness, and clarity of vision were 91 ± 11, 88 ± 11, and 92 ± 9, respectively. Subjective ratings were stable throughout the day with no significant differences after insertion, after 6 hours of digital device use and before CL removal (all p>0.05). The majority of participants agreed that the study lenses performed well, provided good all-day comfort (28/32; p<0.01) and good all-day vision (29/32; p<0.01). Participants also agreed that after ≥6 hours of digital device use they were satisfied with CL comfort (27/32; p<0.01), vision (29/32; p<0.01) and that the lenses provided good performance (26/32; p<0.01). Conclusion: Verofilcon A lenses were found to perform well, with high ratings for comfort, dryness and vision that remained high throughout the day, during extensive digital device use.

Bulbar Redness and Dry Eye Disease: Comparison of a Validated Subjective Grading Scale and an Objective Automated Method.

SIGNIFICANCE: In this study, assessments of conjunctival redness were performed to evaluate whether patients with or without dry eye disease (DED) could be discriminated based on this measure. Our findings suggest that subjectively grading redness by quadrant, as opposed to automated en face measurements, may be more suitable for this purpose. PURPOSE: This study aimed to quantify bulbar redness using the validated bulbar redness (VBR) grading scale and an automated objective method (Oculus Keratograph 5M; K5M) in participants with DED and non-DED controls. METHODS: Participants with DED (Ocular Surface Disease Index score ≥20 and Oxford scale corneal staining ≥2) and controls (Ocular Surface Disease Index score ≤10 and corneal staining ≤1) attended two study visits. In part 1A of visit 1, baseline bulbar redness was graded with the VBR scale in each conjunctival quadrant of both eyes, followed by automated measurements of temporal and nasal redness with the K5M. This was immediately followed by part 1B, during which a topical vasoconstrictor was instilled into both eyes. Redness assessments were repeated 5 and 30 minutes after instillation with both instruments. Participants returned 14 days later for visit 2, where the same assessments as for visit 1A were repeated. RESULTS: Seventy-four participants (50 DED and 24 controls) completed the study. There were statistically significant differences in redness between the DED and control groups when assessed with the VBR scale (14/16 comparisons; all, P < .05), whereas no significant differences in K5M-derived redness between the DED and non-DED groups were found at any location or time point. Both subjective and objective instruments detected statistically significant reductions in redness 5 and 30 minutes after instillation of the vasoconstrictor (all, P < .01). CONCLUSIONS: Although both subjective and objective instruments were sensitive to detecting changes in redness induced by vasoconstriction, statistically significant differences in redness between DED and control groups were only found using the VBR scale.

Efficacy and Safety of Phospholipid Nanoemulsion-Based Ocular Lubricant for the Management of Various Subtypes of Dry Eye Disease: A Phase IV, Multicenter Trial.

PURPOSE: To evaluate the clinical efficacy and safety of propylene glycol/hydroxypropyl-guar (PG-HPG)-based nanoemulsion (Systane® Complete) lubricant eye drops in participants with dry eye disease (DED). PARTICIPANTS AND METHODS: In this phase IV, open-label, single-arm, interventional, multicenter study, adult participants with DED - subtyped into aqueous deficient, evaporative, and mixed dry eye - were instructed to instill one drop of PG-HPG in each eye twice a day for 28 days. Endpoints included change from baseline in tear film break-up time (TFBUT) (primary) and ocular discomfort visual analog scale (VAS) score at Day 14 and TFBUT at Day 28 (secondary). Safety was assessed throughout the study. Data were analyzed for overall patient cohort and by DED subtypes. RESULTS: A total of 134 participants received treatment (mean age: 56.6 years; female: 75.4%). At Day 14, the mean (standard deviation [SD]) TFBUT increased from 2.6 (1.00) seconds at baseline to 4.2 (2.92) seconds (mean change: 1.5 [2.80] seconds); median change was 0.8 seconds (95% CI: 0.52, 1.19) for the overall cohort; the change was maintained at Day 28 (mean change: 1.4 (2.80) seconds, median change: 0.8 seconds (95% CI: 0.49, 1.17). Subgroup analysis showed a mean change (SD) from baseline in TFBUT of 1.1 (2.41) seconds for aqueous deficient, 2.4 (3.17) seconds for evaporative, and 1.2 (2.63) seconds for mixed dry eye at Day 14, respectively. The ocular discomfort VAS score improved (decreased) from baseline at Day 14 (mean [SD] change: -17.3 [24.80]) for the overall cohort, -22.0 [21.73] for aqueous deficient, -17.6 [24.17] for evaporative and -13.1 [27.49] for mixed dry eye subgroups). Adverse events (AEs) were reported in 9 (6.7%) participants. No serious AEs were reported during the study. CONCLUSION: Our study findings demonstrated that PG-HPG-based nanoemulsion lubricant eye drops were effective and well tolerated in participants with DED and all of its subtypes.

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

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

Lid Wiper Epitheliopathy in Soft Contact Lens Wearers.

PURPOSE: To evaluate lid wiper epitheliopathy (LWE) in soft contact lens (SCL) wearers on initial presentation and after using various SCL and solution combinations. METHODS: LWE was assessed in 253 habitual SCL wearers who attended a screening visit at one of three study sites. LWE was assessed using lissamine green and sodium fluorescein dyes (Korb scale); a final LWE grade was calculated as the averaged LWE grade of the two dyes. Eligible habitual wearers continued into the four study periods, during which they wore one of three SCL types (etafilcon A, galyfilcon A, or senofilcon A) while using each of four care solutions for 10 to 14 days in randomized order. Statistical analyses were performed using linear mixed models, testing for differences in LWE for subject characteristics and between three multipurpose (MPS) test solutions (BioTrue, OPTI-FREE PureMoist, RevitaLens OcuTec) compared to a hydrogen peroxide (Clear Care) control solution. RESULTS: LWE was present in 85% of habitual SCL wearers. LWE was not different for age (p = 0.28), sex (p = 0.99), race (p = 0.34), and comfort (p = 0.38) and not correlated with refractive error (r = 0.07). LWE was lower in habitual senofilcon A wearers (least-squares (LS) mean ± SE = 0.82 ± 0.19) compared to wearers of lotrafilcon B (1.34 ± 0.20; p < 0.02), comfilcon A (1.41 ± 0.21; p < 0.01), and other (1.18 ± 0.16; p < 0.03). Two hundred three participants completed all four study solutions with their assigned lens type; LWE was not different between the MPSs compared to the peroxide control solution across lens materials, except for less LWE for BioTrue (0.88 ± 0.17) versus Clear Care for participants wearing galyfilcon A (1.11 ± 0.18; p < 0.01). CONCLUSIONS: On initial presentation, LWE was present in 85% of habitual wearers and found to be independent of age, sex, race, comfort, and refractive error but dependent on habitual SCL type. There were no clinically meaningful differences in LWE between the MPSs and hydrogen peroxide solution for the three lens types studied.