How satisfied are children wearing full-time daily disposable soft contact lenses?

Paper title: Six years of wearer experience in children participating in a myopia control study of MiSight® 1 day

Authors: Elizabeth Lumb (1), Anna Sulley (2), Nicola S Logan (3), Debbie Jones (4), Paul Chamberlain (5)

1. CooperVision International Ltd., Delta Park, Concorde Way, Segensworth North, Fareham PO15 5RL, UK.
2. CooperVision International Ltd., Chandler's Ford, Eastleigh SO53 4TE, UK.
3. School of Optometry, Aston University, Birmingham B4 7ET, UK.
4. Centre for Ocular Research & Education (CORE), School of Optometry and Vision Science, University of Waterloo, Canada.
5. CooperVision Inc., 5870 Stoneridge Drive, Pleasanton, CA 94588, United States.

Date:  May 2023

Reference:Lumb E, Sulley A, Logan NS, Jones D, Chamberlain P. Six years of wearer experience in children participating in a myopia control study of MiSight® 1 day. Cont Lens Anterior Eye. 2023 May 6:101849.

[Link to paper]

This study evaluated wearer experience data from the MiSight® 1 day clinical study, which is the longest running study of soft contact lens wear in children. So far, this study has reported efficacy data on the 3 year randomized clinical trial, continued tolerance and efficacy data over 6 years, long-term robust safety outcomes and more. Click on each of the links to learn more.

Wearer experience metrics reported in this new paper included wearing times, handling, comfort, subjective vision, visual acuity, overall satisfaction, children's reported activities and parental assurance regarding ongoing contact lens suitability for their children. Here were some key findings.

• Retention rate was around 80% for Part 1 of the study (the 3 year randomized controlled trial where children aged 8-12 at fitting wore either MiSight® 1 day dual-focus or Proclear® 1 day single vision soft contact lenses). It was similar in Part 2 of the study, where children aged 11-16 years either continued wearing MiSight 1 day or were refit to MiSight 1 day from Proclear 1 day, for another 3 years. This indicates that older children adapted well to refitting from single vision to dual-focus contact lenses.
• Wearing time increased from Part 1 to Part 2 of the study: from 13 to 14 hours per day for weekdays and 12 to 13 hours per day on weekends.
• After 1 month of wear, high ratings for ease of handling were reported, and this was stable throughout the study, including for the children fit from single vision to MiSight 1 day after 3 years. Age did not influence handling ratings. Around 20% of parents needed to provide handling support in the initial fitting but this reduced to only 10% helping with application by 6 months, and only 6% helping with removal after 1 month.
• Comfort was rated highly with 94% of children saying they didn't notice or sometimes noticed their contact lenses. Only 1 participant in Part 1 (n=65) and another 1 in Part 2 (out of 56) discontinued due to comfort.
• Subjective vision ratings were high throughout the study, with no impact of lens type or study part (eg. new fits in older children in Part 2). Three children from a total of 7 lens-related discontinuations (n=56) cited vision as their main barrier when switched from single vision to MiSight 1 day.
• Visual acuity was at least 0.00 logMAR (6/6 or 20/20 equivalent) for both treatment and control groups in Part 1. In Part 2, both MiSight 1 day wearing groups (one experienced and one new) had similar distance and near acuity, again at this same level.
• Parents and children were overall satisfied with contact lens wear throughout the study and parental confidence increased from baseline to 1-month onwards.

The MiSight 1 day study has shown that the vast majority of children fit at age 8-12 years (in Part 1) and 11-16 years (at Part 2) will have a positive wearer experience as well as a robust myopia control effect. Older children are not more likely to struggle with vision after wearing single vision compared to those fit when younger. High satisfaction with lens wear is reflected in wearing times of 13-14 hours per day throughout the study.

1. Older children fit with dual-focus contact lenses without prior contact lens experience could potentially have a different pattern of adaptation and satisfaction.
2. Parental satisfaction is somewhat self-selecting as more concern could lead to discontinuation of wear. Similarly, subjective questionnaire data can be subject to bias, but the results were consistent throughout the study.
3. The influence of different clinical communication interactions on continued wear and satisfaction is not known, as these were not scripted, although with high retention rates and strong satisfaction results, this may not have had a significant impact on outcomes.

Title:Six years of wearer experience in children participating in a myopia control study of MiSight® 1 day

Authors: Elizabeth Lumb, Anna Sulley, Nicola S Logan, Debbie Jones, Paul Chamberlain

Purpose:To evaluate the experience of children wearing soft contact lenses (CLs) during a trial of MiSight® 1 day (omafilcon A, CooperVision, Inc.), a dual-focus myopia-control daily disposable CL.

Methods: A 3-year, double-masked, randomised trial (Part 1) comparing experiences with MiSight 1 day and a single-vision control (Proclear® 1 day, omafilcon A, CooperVision, Inc.) of neophyte, myopic children (ages 8-12). Treatment (n = 65) and control (n = 70) participants received lenses at sites in Canada, Portugal, Singapore, and the UK. Successful participants completing Part 1 were invited to continue for a further 3 years wearing the dual-focus CL (Part 2), and 85 participants completed the 6-year study. Children and parent questionnaires were conducted at baseline, 1 week, 1 month, and every 6 months until the 60-month visit, with children only also completing questionnaires at 66 and 72 months.

Results:Throughout the study, children reported high satisfaction with handling (≥89% top 2 box [T2B]), comfort (≥94% T2B), vision (≥93% T2B for various activities), and overall satisfaction (≥97% T2B). Ratings for comfort and vision were not significantly different between lens groups, visits, or study parts and did not change when children switched to dual-focus CLs. Ratings for 'really easy' or 'kind of easy' application improved from the outset for the neophytes (57% at 1-week follow-up and 85% at 1-month follow-up) and remained high throughout the study (visit: P = 0.007; part: P = 0.0004). Overall satisfaction improved in Part 2 (P = 0.04). Wearing times increased in Part 2 (14 vs. 13 hrs/weekday; 13 vs. 12 hrs/day on weekends; P < 0.001); there were no differences between groups.

Conclusions:Children adapted rapidly to full-time wear, rated lenses highly, and rarely reported issues. The dual-focus optics included in the MiSight® 1 day lenses successfully achieved myopia control without lowering subjective ratings when fitted to neophytes or children refitted from single-vision CLs.

[Link to paper]