Coopervision has released data from a five-year, two-part study into the effects of its Misight 1 day contact lenses on children with myopia.
Due to be published at the British Contact Lens Association (BCLA) Conference in late May but postponed until this month, Coopervision called the research the ‘world’s longest-running clinical trial involving children wearing contact lenses’. The company said its ‘landmark study’ came at precisely the right time as ‘optometrists, ophthalmologists and public health authorities are facing the growing worldwide severity and prevalence of progressive childhood myopia’.
‘The data and insights from this multi-year clinical trial are powerful, reinforcing the positive impact of this lens on myopic children,’ said Daniel McBride, president of Coopervision.
Part one of the study quantified the three-year effectiveness of the Misight lens compared with an equivalent single vision 1-day lens in slowing the rate of progression of juvenile-onset myopia. In both groups myopia and axial length measurements were taken. Part two of the study commenced on the 36-month mark, where children in the control group were refitted with the Misight lens. They continued to be tracked separately to assess the rate of myopia progression between the two cohorts.
‘As the two groups are now wearing Misight we are now able to look at the rate of change among those two groups. There was a pretty dramatic change in the rate of progression of both refractive error and axial length in the control group that can’t be explained by natural slowing down,’ Elizabeth Lumb, professional services head of Misight, told Optician at the BCLA conference.
Even though the results had not been released at that point, Coopervision asserted that there was a myopia control element to its lens. ‘The conclusion of the results of this data tells us that age is the most compounding factor and not the starting prescription or axial length, that helps us to define what happens next with myopia control. The study shows that those children from 11 to 15 are still getting benefit from Misight and that’s a great news story,’ said Lumb.
In short, progression rates among the refitted control group matched the original Misight wearing group for the duration of the study, suggesting that ‘myopia progression with Misight 1 day lenses is more dependent on age of the patient than their baseline myopia or length of time under treatment,’ said Paul Chamberlain, director of research programmes for Coopervision.
Moreover, the data showed that visual performance remained ‘excellent’ in both groups, with ‘visual acuity of better than 6/6 at every scheduled appointment and no significant differences across groups or visits,’ said Coopervision.
The company said it was ‘delighted’ with the result because ‘the efficacy of Misight 1 day over the first three years of the study demonstrated a sustained reduction in progression of myopia in terms of refractive error and axial length’.
Marketing and national accounts director at Coopervision Mark Draper added: ‘The children who have worn Misight for a total of five years continue to demonstrate a slow, constant rate of change, whereas the children wearing Misight 1 day for a total of two years show a dramatic reduction in the annual rate of change compared to the prior three years wearing Proclear 1 day.’
Asked whether Coopervision were happy with the results, or if they had been expecting more significant evidence, Draper said: ‘Because the children in the control group were switched into Misight 1 day after three years, it’s no longer possible to state efficacy results beyond the three year stage.
‘Instead, the study objective is to compare annual rates of progression and what our analysis demonstrates is that while treating myopia in younger myopic children is advantageous, older progressing myopes can also experience a slowing down of progression in years four and five, which mirrors the rates of change observed in the children who have worn Misight 1 day for the full duration of the study to date.’
Even if the results of the extensive, long-term study had not been quite what Coopervision was hoping for, it has still demonstrated the efficacy of its Misight lens and it offers a valuable management option for younger myopes.
