Refitting contact lens dropouts into a modern daily disposable contact lens

To determine the number of previous contact lens (CL) wearers who could be comfortably refitted into delefilcon A (DAILIES TOTAL1®) CLs.

especially when exacerbated by meibomian gland dysfunction (MGD), is common in CL wearers. 1,3uccessful CL wear is defined by the Cornea and Contact Lens Research Unit (CCLRU) as the ability to wear CLs comfortably for at least 12 h per day for at least 6 days per week, with equivalent vision to spectacle wearers (within one line of best spectacle visual acuity under high and low illumination). 4While CL dropout is common, many of the patients who discontinue CL wear may successfully resume CL wear when given the opportunity to be refitted. 1,57][8] CLs also provide better visual freedom for physical activities and in situations that require masks or other personal protective equipment. 9For many CL wearers, it is a matter of improved cosmesis and self-perception, especially for those who have high refractive errors. 7,8,10ne option that has been found to provide high levels of comfort is delefilcon A CLs (DAILIES TOTAL1®; www.alcon.com). 11Delefilcon A CLs are daily disposable CLs that utilise the latest in advanced material technology to improve lens comfort.Delefilcon A has a low lens core modulus (0.7 Minimum Protection Area) and has a high oxygen transmissibility (156 @ −3.00 D).Designed with Water Gradient Technology, the water content of delefilcon A CLs increases from the core of the CL to the surface, where the water content approaches 100%.Delefilcon A CLs also release phosphatidylcholine during wear, a polar tear lipid that helps to stabilise the lipid layer of the tear film. 12However, to date, there have not been any studies to determine how CL dropouts may potentially benefit when refitted into delefilcon A CL. Thus, the purpose of this investigation was to complete a pilot study to determine the number of CL dropouts who can comfortably wear delefilcon A CLs.These data are valuable, not only because they provide practitioners with evidence regarding the success rate of refitting dropouts into modern CLs, but also provide important information for helping reduce CL dropout in general.

Subjects
This 6-month, three-visit clinical study was conducted at the Southern College of Optometry (Memphis, Tennessee, USA), ProCare Vision Center (Granville, Ohio, USA) and Kannarr Eye Care (Pittsburg, Kansas, USA).One month was deemed an appropriate primary outcome timepoint because Young et al. 5 found that most subjects who dropped out of CL wear did so by the 1-month visit.Subjects were recruited via clinic records, email and fliers, and they were pre-screened with an Institutional Review Board (IRB)approved qualification questionnaire over the telephone.Adult, 18-to 40-year-old (inclusive), past CL wearers who had a Logarithm of the Minimum Angle of Resolution (logMAR) best-corrected visual acuity of 0.00 or better were recruited.Subjects were required to have worn CLs for at least 1 year in the past.Subjects over 40 years of age were excluded to avoid presbyopia-related vision issues.All subjects were required to have dropped out of CL wear within the previous 2 years because of discomfort or dryness.This determination was made by listing  (12)  other.Subjects were considered to be a CL dropout if they had not worn CLs in the past 3 months.Subjects were required to have Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire scores ≤3 to ensure that they had no clinically meaningful dry eye symptoms. 13In addition, they were required to be able to wear delefilcon A CLs and have astigmatism ≤0.75 D in each eye.Subjects were required to provide a spectacle prescription <3 years old to ensure that they were receiving proper eyecare.They were excluded if they were past rigid CL wearers, had a history of dry eye disease or ocular allergies, a known systemic health condition that was thought to alter tear film physiology, had a history of viral eye disease, ocular surgery, severe ocular trauma, corneal dystrophies or degenerations or active ocular infection or inflammation, were currently using isotretinoinderivatives or ocular medications or if they were pregnant or breast feeding. 14

Clinical testing
This study was approved by the Southern College of Optometry's Institutional Review Board (IRB), and followed

Key points
• Practitioners frequently assume that patients who have ceased wearing contact lenses are ill-suited to wear any type of contact lens in the future, while patients might make the same incorrect assumption.• The present work found that the 60 subjects who were refitted with DAILIES TOTAL1® contact lenses were all still wearing the lenses at 1 month and all but one subject was still wearing these lenses at 6 months, which is a much higher rate than previous studies.• Patients who have previously dropped out of contact lens wear due to discomfort and/or dryness can be successfully refitted with DAILIES TOTAL1® contact lenses.
the Declaration of Helsinki.This study was registered with Clini calTr ials.gov (NCT05239494).Subjects who reported for the baseline visit had their eligibility confirmed by repeating the IRB-approved qualification questionnaire.
Qualifying SPEED questionnaire scores were also verified. 15Non-eligible subjects were dismissed at this time.
Eligible subjects provided informed consent, were enrolled and asked to sign US Health Insurance Portability and Accountability Act (HIPAA) documentation.All relevant subject demographics were collected at this time via a questionnaire developed by the investigators.A manifest refraction was performed on each subject via the investigator's standard of care.Binocular balancing was performed, and no more than 1.00 D of sphere was allowed to be added beyond the initial blur balance starting point.The investigator then evaluated both eyes with a slit-lamp biomicroscope to document normal and/or remarkable findings of the anterior ocular structures (eyelashes, eyelids, conjunctiva and cornea).Subjects were then fitted with the study CLs.The lenses were evaluated for centration, movement, coverage and power.CL power adjustments were made only if they visual acuity.Subjects were then dispensed an initial supply of were asked to return in 1 week.
At the 1-week visit, the SPEED questionnaire was repeated.The CLs were evaluated for fit and power, and the subjects' ocular health was re-examined with the slit-lamp biomicroscope as described above.A new supply of study CLs was dispensed, and subjects were scheduled for their 1-month visit.At this 1-month visit, the same testing as for the 1-week visit was performed; however, they also completed an investigator-designed questionnaire aimed at understand their CL wearing experience.This questionnaire included five Likert questions, which focused on CL comfort, wear time and vision, as well as the following visual analogue scale (VAS) question: 'Overall, how satisfied are you with the comfort of your current contact lenses over the past week?'The VAS scale was a ±50 scale, with positive and negative scores being comfortable and uncomfortable, respectively. 16Subjects were then provided with a complementary 6-month supply of CL and released from the clinical portion of the study.Lastly, they were sent an electronic Likert questionnaire after 6 months of wearing the study CLs, which again focused on CL comfort, wear time and vision.After completing all testing and questionnaires, the subjects were compensated for their time and released from the study.

Sample size and statistical analysis plan
This was a pilot study to understand if CL dropouts could be refitted with delefilcon A CLs.The primary outcome was the VAS comfort score at the 1-month visit.A formal sample size calculation was not performed, given that the study had a single arm and was not comparative.Thus, a sample of 60 subjects was selected because it was deemed a reasonable and feasible number of subjects who could be recruited over a 6-month period.This number was likewise deemed sufficient to begin understanding the qualitative experience of uncomfortable CL wearers who were being refitted with new lenses based upon a past study conducted by the investigators. 17ata were captured electronically using Research Electronic Data Capture (REDCap; proje ct-redcap.org/ ).18,19 Stata/IC 17 (StataCorp LLC; stata.com) was used to analyse the data. This udy's primary outcome was a ±50 VAS at the 1-month visit.The percentage of subjects who reported a positive (comfortable) score on this VAS was also recorded.When the ±50 VAS scores at this visit were analysed with the Shapiro-Wilk test, the data were found to be non-normally distributed (p < 0.001).Thus, non-parametric statistics were used.20 Continuous results were summarised as medians with interquartile ranges (IQR), while categorical results were summarised as percentages.Kruskal-Wallis tests were used to compare continuous variables across the life of the study.Comparisons were considered significant for p < 0.05.

R ESULTS
This study recruited 60 subjects with a median (IQR) age of 24.0 (7.0) years and 71.7% were female.All subjects completed the 1-month visit; however, one subject was unable to be contacted for the 6-month survey.The subjects identified as Asian (10.0%),Black or African American (3.3%), White (83.3%), more than one race (1.7%) or race unknown or not reported (1.7%), with 1.7% being of Hispanic descent.This study failed to detect any adverse events with slit-lamp biomicroscopy at any visit, and no subjects selfreported any adverse events.
All enrolled subjects reported that their primary reason for dropping out of CL wear was discomfort or dryness.They had baseline manifest refraction sphere and cylinder powers of −2.  1).
The median VAS score at the 1-month visit was 44.0 (8.0) units, with all subjects reporting a positive/comfortable score.The median SPEED score was 2.0 (1.0), 0.0 (2.0) and 1.0 (2.0) at the baseline, 1-week and 1-month visits, respectively, which differed significantly over the duration of the study (p < 0.001).When asked at the 1-month visit to report on their CL wearing experience over the last week, the subjects indicated that they wore their CLs a median of 10.0 (4.0) h per day, had a median of 8.0 (5.0) comfortable hours of wear per day and that they wore their CLs for 6.0 (2.0) days.Over the past week, most subjects were either very satisfied or satisfied with the vision in the study CLs (98.3%), with the comfort of the study CLs at the end of the day (86.5%) and with the overall comfort of the study CLs (93.2%) (Table 2).Furthermore, 89.6% of the subjects indicated that they were very likely or likely to continue wearing the lenses, and 98.3% that they would recommend the study CLs to a friend (Table 2).
The subjects were contacted via electronic questionnaire after wearing the study CLs for 6 months.They reported that they wore their CLs a median of 6.0 (2.0) days over the past week, with all 59 respondents indicating that they wore their CLs for at least 1 day over the past week.They also reported that over the past week, they wore their CL a median of 11.0 (6.0) h per day and that the lenses were comfortable for a median of 10.0 (5.5) h per day on days when they were worn.Likewise, at 6 months, most subjects were either very satisfied or satisfied with their overall vision (93.2%), comfort at the end of the day (78.0%) and overall comfort (91.5%) over the past week (Table 3).Most subjects stated that they were very likely or likely to continue wearing the study CLs daily (80.7%), and 93.2% indicated that they would recommend the study CLs to a friend (Table 3).

DISCUSSION
This study aimed to understand the utility of refitting CL dropouts into a modern daily disposable CL.Interestingly, all enrolled subjects were still wearing the CLs at the completion of the 1-month visit, and all 59 subjects who completed the 6-month questionnaire were still wearing the CLs.Subjects were likewise overwhelmingly happy with their vision and CL comfort at both the 1-month visit and the 6-month timepoint, and most subjects indicated that they planned to continue wearing these CLs after completing the study.The subjects also reported consistently

Questions Frequency of responses (%)
Overall, how satisfied are you with your vision in your current contact lenses over the past week?
that they would recommend the study CLs to a friend.Nevertheless, there were still a minority of subjects who were either unsatisfied or very unsatisfied with some aspect of the CLs as judged by the Likert questionnaire.This is to be expected given that the study population was required to have a history of CL dropout.
Simply refitting patients into an alternative CL option has the potential to decrease CL dropout, especially if a newer generation of lenses can provide improved comfort. 5 Young et al. 5 were one of the first groups to evaluate refitting CL dropouts into an alternative CL.The authors specifically recruited 236 lapsed CL wearers, and refitted them into any suitable alterative CL.It was determined that 77% of their subjects were wearing the CLs after 1 month and 55% were still wearing the CLs after 6 months. 5nterestingly, only 26% of Young et al.'s subjects indicated that they had no intentions of resuming CL wear at the 6month visit.The current study found that all 60 subjects who were refitted with the study CLs were still wearing them at 1 month and all but one subject was still wearing the CLs at 6 months, which is a substantially higher success rate than Young et al. found in their investigation.This difference between studies could be related to the current investigation only refitting the subjects with one type of advanced, daily disposable CL, whereas Young et al. allowed any type of planned replacement CLs.The effects of the wearing schedule itself could have also influenced the observed differences.Material technology has likewise advanced substantially since Young et al.'s 2002 study. 5,21To the best of the authors' knowledge, there are no other prospective studies aimed at specifically refitting CL dropouts.
While the goals of wearers vary, CL comfort is paramount for continued CL use. 1 The primary endpoint of this study was comfort VAS scores at the 1-month visit.This study specifically used a ±50 VAS scale, with values in the positive and negative range indicating that the CLs were comfortable or uncomfortable, respectively. 16A score of zero on this scale indicated neutral CL comfort.While this scale is not the typical 0-100 VAS scale, it clearly indicates if a subject was happy with the comfort of the CL. 16,22,23Remarkably, the median VAS score at the 1-month visit (IQR) was 44.0 (8.0) units, with all subjects at 1 month reporting a positive (comfortable) VAS score.Interestingly, the Likert results indicated that 5.1% of the subjects were dissatisfied with the comfort of their CLs over the past week.This discrepancy may be explained by the use of different instruments, but it does suggest that a small minority of the subjects were still unhappy with their CLs.Additionally, while SPEED scores differed significantly at the 1-month visit compared to baseline, they were within the normal range at all timepoints, which suggests no clinically meaningful difference between visits. 13Given that the enrolled subjects were required to have dropped out of CLs within the past 2 years because of discomfort or dryness, this endpoint suggests that most patients who had previously dropped out of CL can be successfully refitted with a delefilcon A CL and are likely to experience excellent comfort.
The current study used an investigator-designed Likert scale to evaluate patient-reported CL performance.Examination of the categorical positive responses (i.e., very satisfied and satisfied, very likely and likely) to the 1-month Likert questionnaires reveals that 98.3% of subjects were satisfied with their vision using delefilcon A CLs in the prior week of wear, 93.2% of subjects were satisfied with overall comfort, 86.5% of subjects were satisfied with endof-day comfort and 89.6% intended to continue wearing the study CLs.These findings were slightly better than the Likert scale results found after 6 months.Since it is unclear whether the slightly decreased responses at 6 months were clinically meaningful, additional study is needed.Yet, as mentioned previously, given the challenging group of subjects included in this study who had previously discontinued CL use altogether, the results are very positive.Furthermore, the final query at 6 months was remarkable given that 93.2% of enrolled subjects stated they would recommend delefilcon A CLs to a friend.
One simultaneous strength and weakness of the current study is that subjects were only refitted into one type of spherical daily disposable CL.While treatment homogeneity limits the potential for cofounding factors that would have been introduced by allowing any type of alterative CL to be used (as was the case in Young et al.'s work), 5 the results from the current study can only be applied to patients who were refitted with delefilcon A CL. Hence, it is unclear if the results of this study are generalisable to patient groups not included here (e.g., high refractive error or toric CL wearers).It is possible that other new-generation soft CLs could also provide relief of CL discomfort for previous CL dropouts, and additional studies involving alternative lenses are needed to evaluate this question fully.An additional limitation of this investigation was that it was a pilot study without a formal sample size calculation.This was partly because this study design did not include comparisons to baseline given that the goal was to evaluate patient-reported outcomes in subjects who were initially not wearing CLs but subsequently resumed CL wear.With the data from the current study, we understand that about 10% of subjects refitted with delefilcon A were still unhappy wearers.This information can be used to design a future study, not only to determine if the results of this study can be corroborated, but also to be adequately powered to examine factors associated with unhappiness with delefilcon A CLs (e.g., age, sex and race/ethnicity).Finally, only one daily disposable CL was tested in the present work, and additional investigations are needed to understand if modern reusable soft CLs are also able to rescue CL dropouts.

CONCLUSION
CL dryness and discomfort are often the primary reasons for CL dropout. 1 Despite the aforementioned challenges, CL wearers often maintain interest in wearing lenses even if they have ceased CL wear, and if given the chance, this study reaffirms that CL dropouts can successfully resume CL wear.The current study specifically determined that when CL dropouts were refitted with delefilcon A CLs, which are composed of a novel water gradient material, all subjects were able to successfully resume CL wear for at least 1 month and all but one subject was still wearing the study CLs at the time of the 6-month questionnaire.These same individuals indicated that they had good vision and comfort while wearing the study CLs and that they would recommend wearing these CLs to a friend.Nevertheless, a small minority of subjects were still unhappy with the study CLs, although there is still a chance that they may like an alternative lens.Thus, the results of this study suggest that when a practitioner encounters a CL dropout, they could educate the patient about trying an alternative CL material, such as daily disposable CLs and lenses made of delefilcon A, during the refitting process.
50 D (3.25 D) and 0.00 D (0.38 D) in the right eye, respectively, with equivalent values for the left eye of −2.50 D (3.00 D) and 0.00 D (0.50 D).Subjects had best-corrected visual acuity of −0.10 (0.20) and −0.10 (0.15) logMAR in the right and left eyes, respectively.Median final CL powers were −2.38 D (2.13 D) and −2.50 D (3.00 D) in the right and left eyes at the baseline visit, respectively, after adjusting for any over-refraction.While wearing these CLs at the baseline visit, the visual acuity was −0.10 (0.15) and −0.10 (0.20) for the right and left eyes, respectively.Neither the CL power (p ≥ 0.97) nor the visual acuity (p ≥ 0.16) changed significantly over the first month of the study (Table Contact lens power and visual acuity data by visit (n = 60).
T A B L E 1