The change of subjective grading and objective assessment in Asian young adults after switching to a silicone hydrogel daily disposable contact lens

doi:10.21203/rs.3.rs-4279711/v1

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Research Article

The change of subjective grading and objective assessment in Asian young adults after switching to a silicone hydrogel daily disposable contact lens

https://doi.org/10.21203/rs.3.rs-4279711/v1

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Purpose

To evaluate the comfort and tear film stability of verofilcon A lenses among young Asian adults.

Methods

56 participants wore verofilcon A lenses for 8–10 hours daily for a week. Subjective assessments, including comfort, visual quality, and eye dryness, were conducted using a numerical rating scale (0–100) on the first and seventh days. Noninvasive tear breakup time (NITBUT), bulbar conjunctival redness (BR), tear meniscus height (TMH), and meibography were measured with the Keratograph M5 at baseline, the first day, and the seventh day.

Results

After the seventh day, subjective ratings showed increased comfort and decreased visual quality and dryness. Comfort and visual quality scores on the first and seventh days were above 85 points, with no significant differences. The average NITBUT significantly improved 15 minutes and 8 hours post-lens application compared to baseline measures (P = 0.019). Tear meniscus height was highest at baseline, with a marginal decrease observed following both 15 minutes and 8 hours of verofilcon A lenses wear (P < 0.001). The most pronounced bulbar conjunctival redness was noted at baseline, decreasing significantly after switching to verofilcon A lenses (P = 0.002). Notably, NITBUT was found to be significantly positively correlated with comfort (P < 0.05).

Conclusions

The switch to daily disposable verofilcon A lenses resulted in maintained comfort and improved tear film stability in the young Asian population studied. A significant positive correlation was observed between NITBUT and subjective measures of comfort.

comfort

dryness

NITBUT

vision quality

silicone hydrogel contact lens

Daily disposable soft contact lenses (CLs) offer a convenient and safe approach to correcting refractive errors. First introduced in the mid-1990s, these lenses have been widely prescribed across the globe.[1] However, wearers of contact lenses may experience discomfort due to a potential disruption of oxygen to the cornea. Of these, dryness-related discomfort is the most prevalent. It accounts for up to 30% of discontinuations,[2, 3] making dryness-related discomfort the primary reason for not using contact lens.[4] CL comfort is influenced by various factors, including lens material,[5] individual characteristics, wearing modality,[6] and lens care solutions.[7] A key determinant of comfort is the interaction between the patient's ocular surface condition and the contact lens.[8] Dryness, the most frequently reported symptom, results from contact lens-induced tear film instability.[9] Contact lens-induced discomfort is a multifactorial condition that may be influenced by the compatibility between the CL and the ocular surface.[8]

A recent study reported a higher prevalence of dry eye disease in Asia than in Western countries, with rates ranging from 7% in the United States to over 30% in Taiwan, Japan, and Korea.[10] Environmental factors may contribute to this disparity.[11, 12] For example, strong sunlight and windy weather are particularly prevalent in some Asian countries. Despite these challenges, the demand for CLs has seen a rapid surge in Asia due to the region's high myopia rate.[13] CL wearers who frequently use computers,[14] work in overheated or air-conditioned environments, or reside in low humidity conditions[15] often experience ocular complaints due to an accelerated tear evaporation rate.

Silicone hydrogel daily disposable contact lenses have seen a steady increase in popularity since its introduction in 2008. These lenses strike a crucial compositional balance, that results in high oxygen transmissibility and excellent on-eye wettability. This balance facilitates the stabilization of the pre-lens tear film, thereby enhancing wearer comfort and visual quality.[16]

Evaluating tear film stability, conjunctival redness, and corneal structural alterations linked with contact lens wear typically entails objective assessments such as Schirmer's test, tear breakup time (TBUT) and tear osmolarity. These methods are commonly employed in clinical practice, but are generally be invasive, time-consuming, and necessitate substantial patient cooperation. To address these limitations, recent studies have validated a noninvasive, efficient, and examiner-independent method for measuring tear breakup time, lower tear meniscus height (TMH), and bulbar redness score.[17, 18] Furthermore, a visual analog scale (VAS) is used to assess the experience and satisfaction of contact lens wearers and to monitor changes in comfort throughout the day.[19, 20]

Verofilcon A lenses provide excellent visual acuity, comfort, and handling. These lenses feature a high-performance moisture layer that increases from 51% water content at the core to over 80% water content on the lens surface, with a Dk/t 35°C of 100 ×10^− 11 (cm²/sec) (mL O₂/mL × mmHg).[21] This study aimed to to critically evaluate both the subjective grading and objective assessment associated with switching from somofilcon A silicone hydrogel daily disposable contact lenses to verofilcon A contact lenses among young Asian individuals.

Study subjects

This study was designed as a prospective and open-label experiment. Since somofilcon A daily disposable silicone hydrogel contact lenses were among the most common silicon hydrogel lenses in Asia, satisfied users of somofilcon A lenses were recruited for the present study. Participants received their habitual contact lenses at the first visit. A total of 58 subjects were recruited from two sites, Chung Shan Medical University and Da-Yeh University. This study adhered to the tenets of the Declaration of Helsinki and received ethical clearance from the Human Research Ethics Committee of Chung Shan Medical University Hospital (No: CS1-22177, approval date: January 18, 2023). The informed consent was obtained from all subjects before the start of the study. Eligible participants were 20- to 30-year-old Asians with myopic eyes (≥ -6.00 DS) who could achieve a monocular habitual visual acuity of at least 20/25 (6/7.5) in both eyes with spherical soft contact lens correction. The participants had no ocular or systemic health conditions and were not taking any medications. Their eyes are of either normal dryness or mildly dry (OSDI scores < 22) and spent more than four hours per day using visual display terminals.[22] The subjects initially wore their habitual lenses before switching to daily verofilcon A contact lenses for 7 ± 2 days. The participants inserted a fresh pair of CLs each day and discarding them at the end of the day. They were provided with one lens type at a time, receiving the second lens type at the second visit. All subjects were current soft contact lens wearers who typically wore their lenses for at least eight hours per day, five days per week.

Study protocol

The trial consisted of three scheduled visits (see the Fig. 1). During the first visit, biomicroscopy was used to evaluate the ocular surface. The non-invasive tear break-up time (NITBUT), bulbar conjunctival redness (BR), tear meniscus height (TMH), and meibography were measured without contact lenses (baseline). Additionally, habitual visual acuity was measured while the participants were wearing their eyeglasses. Subsequently, subjects wore habitual lenses (somofilcon A) for 15 minutes, and data on visual acuity, over-autorefraction, lens fit assessment, NITBUT, BR, TMH, meibography and initial visual analogue scale (VAS) scores were collected. After wearing the habitual lenses for 8 hours, the subjects provided their satisfaction via a VAS. Following this, the subjects wore the habitual lenses for 7 ± 2 days.

At the second visit, on the seventh day of wearing habitual lenses, data were collected after the subjects had worn the lenses for 4 hours. This data included visual acuity, over-autorefraction, lens fit assessment, NITBUT, BR, TMH, meibography, and VAS scores. Subsequently, the subjects discarded the habitual lenses and switched to wearing verofilcon A contact lenses. The same data were collected after the subjects wore the verofilcon A lenses for 15 minutes. After wearing the verofilcon A lenses for 8 hours on the same day, the subjects provided a VAS score. Following this, the subjects wore the verofilcon A lenses for 7 ± 2 days.

During the third visit, on the seventh day of wearing verofilcon A lenses, data were collected on visual acuity, over-autorefraction, lens fit assessment, NITBUT, BR, TMH, meibography, and VAS scores after wearing verofilcon A lenses for 8 hours.

Participants accessed the VAS on an online platform during the research. All participants reported a comfort score ranging from 0 to 100, where 0 indicated "extremely uncomfortable" and 100 represented "extremely comfortable." A score of 0 represented "not at all dry," while 100 represented "extremely dry." Tear film parameters were assessed using a Keratograph 5M (Oculus Optikgerate, Wetzlar, Germany) in a specific sequence to minimize the influence of prior measurements. The parameters were evaluated in the following order: noninvasive keratograph breakup time (both first and average; NITBUT-first, NITBUT-avg), TMH, BR, and meibography.

Statistical analysis

The sample size was determined for a paired t-test to detect the difference in NITBUT while using the verofilcon A lenses on all study visits, with α = 0.05 and a 10% dropout rate. This resulted in screening approximately 64 participants for recruitment. This study employed a non-comparative design, utilizing descriptive statistics to assess survey responses. Survey data were analyzed using SPSS software version 26 (IBM Corp, Armonk, NY). Only one eye (OD assessment) from each subject was included in the data analysis. The paired t-test was conducted to compare the overall and end-of-day VAS scores obtained on Day 1 and Day 7. A clinically significant difference was defined as a change in VAS score of seven points or more. [23] The NITBUT measurements were collected at three time points (baseline, 15 minutes, and 8 hours after wearing verofilcon A). Repeated measures analysis of variance (ANOVA) was utilized to determine the statistical significance of differences among these measurements. Additionally, 95% confidence intervals (CI) of the differences were calculated. When repeated measures ANOVA indicated statistical significance, post hoc pairwise comparisons were conducted using the Bonferroni correction. Pearson's correlation coefficients were employed to examine the relationship between NITBUT and VAS variables. Mixed model analysis was also performed to evaluate the association between NITBUT and the overall VAS with data measured at two time points. Data are presented as mean ± standard deviation (SD), and a p-value of < 0.05 was considered statistically significant.

Participant demographics and the lens fitting

This study recruited 61 soft contact lens users (mean age: 20.73 ± 1.34 years, male/female ratio: 8/50). In the end, 58 subjects completed the follow-up and were included in all analyses. The mean OSDI score was 6.91 ± 5.44, and the average duration of wearing habitual lenses was 17.57 ± 9.20 weeks. The average spherical equivalent and keratometry of the right eye were − 4.14 ± 1.59 D and 43.57 ± 1.55 D, respectively. The visual acuity (VA) of the right eye with habitual lenses and verofilcon A lenses was logMAR − 0.05 ± 0.07, and − 0.07 ± 0.15, respectively. VA did not differ between habitual lenses and verofilcon A lenses.

The fitting evaluation for habitual lenses revealed the following distribution: 43.1% were optimal, 36.2% were acceptably loose, and 8.6% were acceptably tight. Only 8.6% were unacceptably loose, and 3.4% were unacceptably tight. For verofilcon A lenses, 58.6% were optimal, 17.2% were acceptably loose, and 22.4% were acceptably tight. Only 1.7% were unacceptably loose, and none were unacceptably tight in the study. There were no clinically significant differences. The symptoms associated with wearing either habitual lenses or verofilcon A lenses, including dryness, lens awareness, blurred vision, the need for lens cleaning, redness, blurring, and itching, were all below the level of “trace”.

Subjective comfort rating of verofilcon A contact lenses

Subjective evaluations of end-of-day comfort, end-of-day visual quality, and end-of-day dryness on the first day (Day 1) and the seventh day (Day 7) of wearing verofilcon A lenses are presented in Table 1. No significant differences were found in end-of-day comfort, visual quality, and dryness between Day 1 and Day 7 of wearing verofilcon A lenses for 8 hours. Consequently, the subjective grading of comfort, visual quality, and dryness remained consistent throughout the study. The average scores for comfort and visual quality on the first and seventh days of wearing verofilcon A lenses for 8 hours were both higher than 85 points, with no statistically significant differences between Day 1 and Day 7. Regarding dryness, the mean scores for wearing verofilcon A lenses on Day 1 and Day 7 were both approximately 20 points, with no significant differences observed. Although overall satisfaction on Day 7 decreased significantly compared to Day 1 (P = 0.038), the difference was not clinically significant (< 7 points).

Table 1

The end of day and overall score of VAS questionnaire after wearing verofilcon A lenses for day 1 and day 7
VAS	Day 1		Day 7
	Mean	SD	Mean	SD	P-value
End of day comfort	85.34	13.02	84.78	13.24	0.644
End of day visual quality	86.51	14.04	86.54	11.54	0.984
End of day dryness	24.27	19.31	23.61	17.71	0.707
Overall comfort	85.49	16.82	86.83	11.51	0.527
Overall visual quality	88.83	9.19	88.29	11.32	0.601
Overall dryness	21.86	17.87	23.46	19.77	0.539
Overall satisfaction	89.37	10.43	87.12	11.09	0.038
P-value by Paired t-test.

Objective assessment switching verofilcon A contact lenses

In this study, the average NITBUT was analyzed under three time points: without wearing contact lenses (baseline), wearing verofilcon A lenses for 15 minutes on Day 1, and wearing verofilcon A lenses for 8 hours on Day 7. As shown in Table 2, a significant increase in the average NITBUT was observed after wearing verofilcon A lenses for 15 minutes and 8 hours compared to baseline measurements (P = 0.019). However, no significant differences were found in the first NITBUT measurements among the three time points (P = 0.774). Bulbar conjunctival redness was mild at baseline and only varied from 0.26 to 0.23 before and after wearing the verofilcon A lenses (P = 0.002). With verofilcon A lenses, the tear meniscus height was highest at baseline, with a slight decrease at 15 minutes and 8 hours (P < 0.001). Meibography revealed no significant differences after wearing verofilcon A lenses for 15 minutes and 8 hours (P = 0.320).

Table 2

The objective assessment in the subjects before and after wearing verofilcon A contact lenses
OD	Baseline		Verofilcon A 15 minutes		Verofilcon A 8 hours
	Mean	SD	Mean	SD	Mean	SD	P-value
NITBUT ave (s)	14.78^a	7.31	16.59^ab	5.97	17.89^b	5.83	0.019
NITBUT first (s)	12.14	8.22	11.78	8.16	12.83	8.73	0.774
BR	0.26^a	0.09	0.23^b	0.08	0.23^b	0.12	0.002
TMH (mm)	0.26^a	0.05	0.23^b	0.05	0.24^b	0.05	< 0.001
Meibography	0.57	0.38	0.54	0.30	0.61	0.26	0.320
P-value by Repeated Measures ANOVA (analysis of variance).
a, b: Groups with different letters are significantly different by Post hos analysis (P < 0.05).
BR, bulbar redness; NITBUT, non-invasive tear breakup time; TMH, tear meniscus height.

Relationship between comfort rating and NITBUT

Figure 2 illustrates the results of the Pearson correlation coefficient between comfort, visual quality, and NITBUT. In Fig. 2A and 2B, the average NITBUT on the seventh day of wearing verofilcon A lenses (Day 7) demonstrated a significantly positive correlation with comfort during the day (r = 0.268; P = 0.038) and end-of-day visual quality (r = 0.305; P = 0.018). Similarly, the first NITBUT on Day 7 also showed a significant positive correlation with comfort during the day (r = 0.268; P = 0.040).

The objective assessments and subjective grading were analyzed using a mixed model analysis. Table 3 presents the results, indicating that both the first and average NITBUT were significantly positively correlated with the comfort measurement (P < 0.05). However, no significant correlation was observed between TMH and meibography, and a significant negative correlation was found between visual quality and bulbar conjunctival redness. Additionally, the dryness point did not correlate with the objective assessments significantly.

Table 3

Mixed model analysis to assess the correlation between NITBUT and overall VAS
Dependent var.	Comfort		Visual quality		Dryness		Satisfaction
Independent var.	B	95% CI	B	95% CI	B	95% CI	B	95% CI
NITBUT ave	0.31	(0.01 ~ 0.61)^*	0.19	(-0.10 ~ 0.48)	-0.18	(-0.69 ~ 0.32)	0.23	(-0.06 ~ 0.51)
NITBUT first	0.22	(0.01 ~ 0.44)^*	0.10	(-0.10 ~ 0.31)	-0.07	(-0.43 ~ 0.29)	0.16	(-0.05 ~ 0.36)
BR	-20.20	(-41.81 ~ 1.41)	-22.04	(-43.85~-0.24)^*	-0.06	(-36.92 ~ 36.80)	-3.68	(-25.31 ~ 17.95)
TMH	15.94	(-24.92 ~ 56.80)	38.94	(-1.51 ~ 79.40)	-42.65	(-110.74 ~ 25.43)	29.61	(-10.58 ~ 69.81)
Meibography	0.37	(-6.20 ~ 6.94)	-1.07	(-7.42 ~ 5.27)	-0.49	(-11.48 ~ 10.50)	1.16	(-5.11 ~ 7.44)
B: regression coefficient; CI: confidence interval. ^*: P < 0.05
NITBUT, non-invasive tear break-up time; BR, bulbar redness; TMH, tear meniscus height.

This study of Asian young adults represents the first exploration of subjective evaluations and objective assessments following the use of silicone hydrogel daily disposable contact lens. A significant proportion of soft contact lens users report a progressive increase in discomfort with increasing duration of wear, including ocular dryness, irritation, fatigue, burning, or a sensation akin to a foreign body in the eye.[24] These discomfort symptoms have been noted in approximately half to three-quarters of CL users, particularly toward the end of the day.[25] This discomfort may be attributed to the interaction between the lens surfaces and the ocular surface, with changes in the tear film over the course of the day resulting in a decrease in comfort over an 8-hour wear period.[26] Prior research has indicated that comfort ratings decline from morning to evening, even among individuals who do not wear contact lenses, although this decline in comfort is more pronounced among contact lens users.[27, 28] In the present study, no significant differences were observed in end-of-day comfort, visual quality, or dryness between the first and seventh day of wearing verofilcon A lens. Participants reported a positive experience with the verofilcon A lenses, as evidenced by subjective ratings for overall quality of vision, comfort, and satisfaction, all of which were 85 points or higher (out of a possible 100). These findings align with those of Grant and Tang, who found that 81% (n = 218) of verofilcon A contact lens users expressed a preference for these lenses, citing long-lasting comfort, less dryness, and the ability to wear the lenses for extended periods after wearing them for at least eight hours a day over a week.[29] Although a statistically significant decrease in overall satisfaction was noted after seven days of wearing verofilcon A lenses compared to the first day (P = 0.038), this difference was not considered clinically meaningful, as it was less than seven points. Papas et al. reported that the noticeable difference between groups on a similar 1–100 numerical scale as 7–8 points.[20]

Our findings indicate that the average NITBUT exhibited a significant increase after switching to verofilcon A lenses (for wear duration of 15 minutes and of 8 hours) in comparison to baseline measurements (P = 0.019). Llorens-Quintana et al. have reported that the quality of the pre-lens tear film showed a significant decline when compared to the pre-corneal tear film quality.[30] However, this research demonstrated that the material used significantly enhanced the quality of the tear film. Regardless of the duration of wearing verofilcon A lenses, either 15 minutes or 8 hours, the quality of the tear film at both time points surpassed the baseline. Eye discomfort is associated with decreased NITBUT, corneal and conjunctival staining, as well as reduced tear meniscus.[31] Interestingly, the findings indicate that the most intense bulbar conjunctival redness among participants was noted at baseline, with a significant reduction observed after switching to verofilcon A lenses (for both 15 minutes and 8 hours) (P = 0.002). The oxygen transmissibility of contact lens materials has been linked to bulbar redness in lens wearers. If oxygen and carbon dioxide cannot efficiently permeate the contact lens materials, corneal hypoxia may ensue, leading to contact lens-related complications.[32, 33] Montani et al. suggested that such ocular surface changes could be attributed to the contact lens materials.[34] The results in this study indicate reduced bulbar conjunctival redness among subjects after wearing verofilcon A lenses, demonstrating the superior performance of oxygen transmissibility in verofilcon A. Additionally, the high-water gradient and surface treatments of verofilcon A contribute to a lower impact on the wearer’s tear film.[18] Contact lenses crafted from this new material elevate the water content and integrate surface treatments to enhance the pre-lens tear film stability, ultimately leading to improved wettability and thus superior comfort even with daily CL use.[35, 36] The core of verofilcon A lenses has 51% water content. This allows the surface of these lenses to maintain a permanent level of moisture with a water content exceeding 80%, potentially improving the stability of the pre-lens tear film.

A key finding of this study was the significant correlation between subjective ratings and the objective measure using NITBUT. Both the average NITBUT and the first NITBUT demonstrated a statistically significant positive correlation with comfort (P < 0.05). These results indicate that longer tear break times were associated with higher ratings of comfort among contact lens wearers. Thus, tear breakup time can serve as a valuable tool in assessing the quality of pre-corneal and pre-lens tear films, and add to our understanding of the overall comfort associated with contact lens use. Wolffsohn et al. demonstrated that tear breakup time of the daily contact lens surface effectively detected changes in the ocular surface.[37] It is also important to note that light transmission is primarily facilitated by the tear film. The consistency and stability of the tear film significantly influence the optical quality of the retinal image. A shorter tear breakup time may compromise optical quality, potentially leading to suboptimal visual performance.[38] The hydration of the lens, oxygen transmission, and comfort levels can be influenced by environmental factors such as temperature, humidity, and wind velocity. Tranoudis and Efron observed that changes in lens hydration impact lens flexibility, gas permeability, and lens fit.[39] These changes can further affect lens comfort, visual quality, and the physiological integrity of the cornea. Lenses, such as verofilcon A, that facilitate greater oxygen transmission to the eye are associated with fewer hypoxia-related complications, contributing to enhanced comfort and satisfaction overall.

The present study has several limitations. First, the subjective evaluation of both eyes presents a potential limitation, as the overall rating of comfort, visual quality, dryness, and satisfaction may be influenced by the condition of the less comfortable eye, which could lead to an underestimation. Second, given that this was an unblinded, quantitative study, the potential for human error or subjective bias in the findings cannot be entirely excluded.[40] However, the objectivity of assessments such as NITBUT, BR, and meibography, which were automatically determined by the Keratograph 5M, mitigates this limitation. Lastly, the final assessment of the objective parameters and VAS score were conducted on the seventh day of wearing verofilcon A lenses, a duration that may not be sufficient to fully understand the long-term effects of verofilcon A lens use. Future research will seek to extend this wearing period to better evaluate the long-term effects of wearing daily disposablefor verofilcon A lens wearers.

Our findings demonstrated that the daily disposable verofilcon A lenses maintained comfort and improved tear film stability in a population of young Asian. The data revealed a significant positive correlation between NITBUT and subjective measures of comfort. Objective and subjective evaluation of the ocular surface, such as questionnaires and/or clinical assessments of tear break time, may prove beneficial for assessing ocular discomfort.

Author contributions: Yayu Chen and Hanyin Sun designed the study. Yayu Chen and Hanyin Sun performed statistical analysis and manuscript preparation. Renyu Yang assisted in the data collection and helped in the interpretation of the study. Yayu Chen and Hanyin Sun critically revised the manuscript.

Funding details: This work was supported by the Alcon Services AG, Taiwan Branch under Grant [Investigator-Initiated Trial IIT # 75058859].

Competing Interests: No potential conflict of interest was reported by the author(s).

Ethical approval This study adhered to the tenets of the Declaration of Helsinki and received ethical clearance from the Human Research Ethics Committee of Chung Shan Medical University Hospital (No: CS1-22177).

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No competing interests reported.

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The change of subjective grading and objective assessment in Asian young adults after switching to a silicone hydrogel daily disposable contact lens

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Abstract

Purpose

Methods

Results

Conclusions

Figures

Introduction

Methods

Study subjects

Study protocol

Statistical analysis

Results

Participant demographics and the lens fitting

Subjective comfort rating of verofilcon A contact lenses

Objective assessment switching verofilcon A contact lenses

Relationship between comfort rating and NITBUT

Discussion

Conclusions

Declarations

References

Additional Declarations

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