Five things we know about MiSight 1 day

The MiSight® 1 day clinical trial is the longest-running soft contact lens study among children, and is now reporting seven-year data. With such a valuable longitudinal dataset, many questions have been explored ranging from shorter-term and longer-term efficacy, to tolerance and safety and more. Here's some of what we've learnt along the way.

The MiSight 1 day clinical trial was conducted in Singapore, the United Kingdom, Portugal and Canada to provide data on an ethnically diverse population, and enrolled children from ages 8 to 12 years who were then followed for seven years.^1-3 It can be thought of in three parts.

Part 1: The first three years (years 0-3). The randomized controlled trial saw children aged 8-12 years with myopia -0.75 to -4.00D and no more than -0.75DC of astigmatism fit with either MiSight 1 day or single vision (Proclear® 1 day) CLs. The absolute myopia control effect was 0.73D (59%) less refractive progression and 0.32mm (52%) less axial length growth in the MiSight 1 day group after 3 years, compared to the single vision 1 day lens.¹

Part 2: The next three years (years 4-6). The Proclear 1 day single vision wearing children were switched into MiSight® 1 day (T3 group = 3 years of treatment) and the MiSight 1 day wearing children continued (T6 group = 6 years of treatment). In the first three years, the T6 group's axial length grew 0.30mm compared to the T3's (control) groups 0.62mm. In the second three years, both groups showed statistically similar growth of 0.22mm for T6 and 0.18mm for T3. Across Parts 1 and 2, the T3 group's axial length grew by 0.81 ± 0.43mm in total, compared to only 0.49 ± 0.39mm total growth in the T6 group.²

Part 3: The final year (years 6-7). All children were switched from MiSight® 1 day into Proclear 1 day single vision soft contact lenses and monitored for a final year, to assess for any rebound effect. On average, for children aged 8-15 at initiation of treatment, there was no indication that accumulated treatment effect gained following 3 or 6 years of MiSight 1 day wear was lost during a 12-month cessation study. Instead, eye growth reverted to expected, age average myopic progression rates. These outcomes showed no evidence of a rebound effect over 12 months, indicating that myopia control gains are retained.^3,4

Figure 2 (left) and Figure 3 (right) from the open access paper by Chamberlain et al (2022), entitled Long-term Effect of Dual-focus Contact Lenses on Myopia Progression in Children: A 6-year Multicenter Clinical Trial.²

Captions are shown below.

There are some important findings here to highlight.²

1. The majority of children wearing MiSight 1 day responded to treatment, with the data showing that 90% of myopic eyes showed slowing of their myopia progression. This was directly observed in the children whose progression data from three years of Proclear 1 day wear in Part 1 were then compared to their progression while wearing MiSight 1 day for three years in Part 2. There were 10% of MiSight 1 day-wearing eyes which didn't show slowed growth, but this group was too small to undertake further analysis to determine any common factors.
2. The fastest growing eyes showed the greatest reduction in myopia progression. This finding was revealed by examining the children who were in the control group in Part 1 of the study, who then switched to MiSight 1 day in Part 2. A proportional treatment effect was observed, where the younger and faster-progressing children received the maximum benefit.
3. Almost one-quarter (23%) of children who wore MiSight 1 day for the full six years did not exhibit any significant refractive progression of their myopia, with -0.25D or less change over six years when their lenses were fitted between the ages of 8 and 12.

The six-year study showed that visual acuity with MiSight 1 day was better than 0.00 logMAR (6/6 or 20/20) at the dispensing and final visits, with no differences between the group who started wear at age 8-12 (6 years of wear: T6) versus the group who started at age 11-15 (3 years of wear: T3).^2,5,6 Children aged 8-15 years old wearing MiSight 1 day achieved similar distance and near acuity and subjective vision performance compared to those wearing single vision contact lenses.^5,6

A separate study has shown that MiSight 1 day does not influence accommodation or binocular vision function at near.⁷ This means that MiSight 1 day contact lenses can be expected to function similarly to single vision spectacles or contact lenses at near, for these performance measure.⁶ Read more in this Case Study entitled Why MiSight 1 day is not a multifocal contact lens.

The MiSight 1 day retention rate was 81% (109 of 135) in Part 1 and 85% (92 of 108) in Part 2, indicating that the majority of children completed the study.^1,2 Clinical outcomes aside from myopia control efficacy were as follows.

• Contact lens wearing time was an average of 6.5 days a week and around 13 hours per day in both groups. The similar wearing patterns for Proclear 1 day and MiSight 1 day groups in the first 3 years of the study suggest that children readily adapted to the dual-focus design as with the single vision lens. Wearing time increased slightly in the second part of the study, by around 1 hour per day in both groups. This indicates that children who had previously worn single vision contact lenses in Part 1 of the study adapted well to dual-focus optics in Part 2. It also shows that children and teenagers are highly compliant with contact lens wearing time when directed to do so. It also indicates that this sort of wearing schedule is required to achieve similar results in clinical practice - full time wear should be encouraged.²
• No contact lens related serious adverse events (corneal infections, microbial keratitis) were recorded. Daily disposable wear in children aged 8 to 12 who grew up wearing daily disposable lenses full time over 6 years resulted in no significant changes on biomicroscopy (e.g. hypoxia) compared to baseline assessment, with 99% of all slit-lamp observation being grade 1 or less on a 0-4 grading scale.^2,8

At the six-year time point in the study, around half of the children had been wearing MiSight 1 day for the full six years, with the other half having three years of wear, with three years of single vision soft contact lens wear prior. It was found that while starting earlier (age 8-12) is optimal for myopia management, commencing treatment at an older age (11-15 years) could still be beneficial in slowing the rate of myopia progression. These new-to-MiSight 1 day children showed the same progression rate as those who had been wearing MiSight 1 day for three years prior.⁹

In the second part of the study, 60% of the new-to-MiSight 1 day wearers were teenagers and all were switched from Proclear 1 day single vision contact lenses - with no difference in dropout rates to the first three years, indicating good acceptance. The majority of children previously wearing single vision contact lenses for 3 years successfully adapted to the new optics of MiSight 1 day contact lenses, with 82% completing their sixth year of the study. This means myopia control can be successfully commenced even into the teenage years, and even when prior single vision contact lens wear has taken place.²

Measurement and modelling of the six-year data indicated that all observed ages of children wearing MiSight 1 day - from 8 to 17 years of age - showed slower myopia progression by approximately 50%.⁹ The absolute value of that 50% is larger for younger children, who generally are at the time of fastest myopia progression.^10,11 This indicates that the greatest impact on eye growth can occur when myopia control treatment with MiSight 1 day is started early and sustained over many years.⁹

Work presented at the American Academy of Optometry in 2022 indicated no rebound effect in the seventh year of the study, when all children switched from MiSight 1 day to Proclear 1 day single vision soft contact lens wear. Twelve months post-treatment, evidence indicates that no accumulated myopia control benefits were lost following 3 or 6-years of wearing MiSight 1 day. By this time, the study group was aged 16 years or older, and eye growth continued at expected, age-normal rates.³

• Clinical Article: When to start myopia management

• Clinical Article: Mastering MiSight 1 day

• Science Summary: Six-year MiSight 1 day clinical trial data

• Science Summary: Six-year safety data for children wearing soft contact lenses

FDA Indications for use (US only): MiSight® 1 day (omafilcon A) soft (hydrophilic) contact lenses for daily wear are indicated for the correction of myopic ametropia and for slowing the progression of myopia in children with non-diseased eyes, who at the initiation of treatment are 8-12 years of age and have a refraction of -0.75 to -4.00 diopters (spherical equivalent) with ≤0.75 diopters of astigmatism. The lens is to be discarded after each removal.

Availability of interventions with regulatory indications to slow progression of myopia varies by country. CooperVision does not endorse off label prescribing of interventions for myopia control.