Dr. Robin Chalmers Explores Safety Compared to Adult Wearers;
Dr. Ian Filtcroft Investigates Natural History of Myopia Development vs. Clinical Study Data
SAN RAMON, Calif., June 16, 2020—Two scientific papers being presented as part of the ARVO (Association for Research in Vision and Ophthalmology) 2020 virtual conference proceedings provide eye care professionals (ECPs) with new insights to aid contact lens-based myopia management with children. Both can be accessed from the ARVO Media library catalog within ARVOLearn. Abstracts will be published in Investigative Ophthalmology & Visual Science next month.
ReCSS Study Examines Safety of Pediatric Soft Contact Lens Wear
Robin Chalmers, OD, FAAO, Principal Investigator for the ReCSS study (Retrospective Cohort Study of Safety of Pediatric Soft Contact Lens Wear),1 led the effort on behalf of CooperVision as part of its FDA approval for MiSight® 1 day contact lenses.* The study retrospectively reviewed 4,611 clinical charts from 782 children across seven geographically and ethnically diverse private eye care practices in the United States and from 181 children in two randomized longitudinal clinical trials.
The record review included any clinical visits of children through age 16 who were first fit with soft contact lenses when 8 to 12 years old. Clinical records involving adverse events were assessed and classified by an independent expert medical panel. The annualized rate of infiltrative adverse events was very low (0.66%/year with a 95% CI 0.39–1.05) as was the annualized rate of contact lens papillary conjunctivitis (0.48%/year with a 95% CI 0.25-0.82). The study estimated a microbial keratitis rate of 7.4/10,000 years (95% CI 1.8–29.6) in soft contact lens wearers aged 8-16 years, comparable to the estimated rates in adult wearers.
“Parents often ask eye care practitioners if children can safely wear contact lenses. This work adds to the substantial evidence of safe soft contact lens wear in children and should help ECPs reassure families as they consider myopia management options,” said John McNally, OD, FAAO, one of the study’s authors and Senior Director, Clinical Research at CooperVision.
Population-Based Centile Analysis Affirms MiSight® 1 day* Contact Lens Clinical Trial Outcomes
Ian Flitcroft, MA, DPhil, FRCOphth, organized a population-based centile analysis of refractive development to assess outcomes from the CooperVision MiSight 1® day contact lens myopia management three-year clinical study in the context of known growth rates of European children.2 Progression rates for refraction and annual progression were assessed for 113 children participating in the MiSight® 1 day study in Portugal, the United Kingdom and Canada. These were compared to centile calculations for 9,092 Irish children aged 8 to 17, derived from an anonymized sample of optometric health records.
The authors found that treatment led to less progression of myopia than would normally be observed in a standard European optometric practice, and that the control group behaved in the way that would be expected for a typical patient under an ECP’s care.
“As we continue to extend the availability of MiSight® 1 day contact lenses globally to help slow the progression of myopia in young children, this population-based comparison builds even deeper trust in the outcomes of our rigorous three-year clinical study,” said Paul Chamberlain, Director, Research Programs – Myopia, CooperVision and co-author of the latest analysis. “Eye care professionals now have another point of reference to use when evaluating myopia management strategies in conjunction with parents.”
Both studies were supported by grants from CooperVision.
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1 Chalmers R et al. Estimate of Adverse Event Rates in a Retrospective Cohort Study of Safety of Pediatric Soft Contact Lens Wear: the ReCSS Study. ARVO 2020 presentation.
2 Flitcroft D I et al. Centile-based analysis of refractive development in the MiSight® 1 day Myopia Control trial. ARVO 2020 presentation.
* 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.
About CooperVision
CooperVision, a division of CooperCompanies (NYSE:COO), is one of the world’s leading manufacturers of soft contact lenses. The Company produces a full array of daily disposable, two-week and monthly contact lenses, all featuring advanced materials and optics. CooperVision has a strong heritage of solving the toughest vision challenges such as astigmatism, presbyopia and childhood myopia; and offers the most complete collection of spherical, toric and multifocal products available. Through a combination of innovative products and focused practitioner support, the company brings a refreshing perspective to the marketplace, creating real advantages for customers and wearers. For more information, visit www.coopervision.com.
About CooperCompanies
CooperCompanies ("Cooper") is a global medical device company publicly traded on the NYSE (NYSE:COO). Cooper operates through two business units, CooperVision and CooperSurgical. CooperVision brings a refreshing perspective on vision care with a commitment to developing a wide range of high-quality products for contact lens wearers and providing focused practitioner support. CooperSurgical is committed to advancing the health of women, babies and families with its diversified portfolio of products and services focusing on medical devices and fertility & genomics. Headquartered in San Ramon, Calif., Cooper has a workforce of more than 12,000 with products sold in over 100 countries. For more information, please visit www.coopercos.com.
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