Scientific Evidence Presented at BCLA and ARVO Conferences
RICHMOND HILL, ON., CANADA, June 14, 2023—Two recently presented studies provide additional evidence to support why more than 175,000 age-appropriate children worldwide are successfully wearing CooperVision MiSight® 1 day soft contact lenses for myopia control.1 New research focused on distance vision and image quality complements the international, multi-site, seven-year clinical trial that demonstrated sustained slowing of eye growth*2 and evidence indicates that there is no rebound effect†3,4 for the innovative intervention.
“With myopia management now the standard of care in Canada,5 it’s critical that children have an outstanding first experience when receiving treatment. CooperVision has proven MiSight® 1 day’s effectiveness of slowing the progression of myopia*2 through unequaled long-term research. Now we are giving eye care professionals even more prescribing confidence by reinforcing its visual performance,” said Elizabeth Lumb, BSc (Hons) MCOptom, FBCLA, Director of Global Professional Affairs, Myopia Management, CooperVision.
Short Term Visual Performance of Two Myopia Control Soft Contact Lenses (Guthrie S., et al.) enrolled 26 neophyte children ages 8-15 in a double masked, single visit, non-dispensing trial where MiSight® 1 day and ACUVUE® Abiliti™ 1-Day lenses were fit and worn contralaterally for one hour in randomized eyes. Children in MiSight® 1 day rated their subjective vision distance as significantly higher‡6 and showed significantly better distance visual acuity.§6 Among children who expressed a lens preference based on vision, more than 90% chose MiSight® 1 day.‖6 Managed by the Centre for Ocular Research & Education (CORE), the study was presented at the 2023 BCLA Clinical Conference & Exhibition.
A separate study examined the optical designs of the same two lenses to better understand clinical reports of MiSight® 1 day’s superior image quality.¶‡6,7 Image Quality Characterization of Myopia Control Contact Lens Designs (Richards J., et al.) computed point spread functions, image quality, and simulated retinal images for a model young eye for a range of pupil sizes. Researchers found that the combined effects of the blur circles from ACUVUE® Abiliti™ 1-Day’s central +10D coaxial zone and its non-coaxial rings introduced image degradation across the entire pupil range. ¶7 The MiSight® 1 day lens, which is designed with a dedicated, clear vision central zone, ensures high image quality. The investigation was conducted by Indiana University and presented at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting.
Currently available in more than 30 countries, MiSight® 1 day is the first and only soft contact lens approved# by the U.S. FDA and China NMPA to slow the progression of myopia in children aged 8-12 at the initiation of treatment.**7 CooperVision also offers a range of orthokeratology designs and spectacles with Diffusion Optics Technology™ for myopia management, which are currently available in select markets.††
# # #
* While eyes are still growing; children fit ages 8-12 and followed for 5-years. n=40
† 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.
‡ Subjective distance vision ratings collected at 1 hour using a 0-100 scale (0 unacceptable, 100 excellent), p<0.01.
§ Distance visual acuity (logMAR) photopic and mesopic measured at 1 hour, p<0.01.
‖ Subject preference and reason for preference at 1 hour, p<0.01.
¶ Based on both modelling and patient subjective ratings. Simulations performed assuming a centered -3.00D lens and a decentered -3.00D lens (inferiorly -0.24mm and temporally -0.39mm). Wavefront errors measured with an SHSOphthalmic aberrometer (Optocraft GmbH).
# U.S. Indications for Use: 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. China Indications for Use: MiSight® 1 day is indicated for the correction of myopia for patients with non-diseased phakic eyes, who at the initiation of treatment are 8-12 years of age and have a refraction of -0.75 D to -4.00 D with ≤ 0.75 diopters of astigmatism. It has the dual focal design with alternative multiple rings, which allows part of the light passing through the optical zone to focus in front of the retina, forming myopic defocus with the expectation to slow the change of axial length of the patients. Fitting and evaluation of the product should be in medical institutions by ophthalmologists with an intermediate title or above and with regular monitoring. It must be used in strict accordance with the IFU requirements. Canadian Indications for Use: MiSight (omafilcon A) Soft Contact Lenses for Myopia Control may reduce the rate of myopia progression in children (6-18) and correct ametropia. Reduction of myopia progression was observed in children with wearing time of 12 hours (8-16 hours) per day, 6.4 days (5-7) per week in a clinical study. Permanent myopia control after lens treatment is discontinued is not supported by clinical studies. MiSight (omafilcon A) Soft Contact Lenses for Myopia Control are indicated for single use daily disposable wear. When prescribed for daily disposable wear, the lens is to be discarded after each removal.
**Compared to a single vision 1-day lens over a 3-year period.
††Spectacles with Diffusion Optics Technology are not approved for sale in the United States.
1. CooperVision, data on file 2022. Internal global wearer modeling estimates for the 12-month period of October 2021 to September 2022.
2. Chamberlain P, et al. Long-term Effect of Dual-focus Contact Lenses on Myopia Progression in Children: A 6-year Multicenter Clinical Trial. Optom Vis Sci. 2022 Mar 1;99(3):204-212.
3. Chamberlain P, Arumugam B, et al. Myopia progression on cessation of Dual-Focus contact lens wear: MiSight 1 day 7 year findings. Optom Vis Sci 2021;98:E-abstract 210049.
4. Hammond D, Arumugam B, et al. Myopia Control Treatment Gains are Retained after Termination of Dual-focus Contact Lens Wear with no Evidence of a Rebound Effect. Optom Vis Sci. 2021;98:E-abstract 215130.
5. Canadian Association of Optometrist, Position Statement on Myopia Management. https://opto.ca/document/cao-position-statement-myopia-management. Accessed January 2023.
6. CVI data on file 2023. Double masked, single visit, short-term, contralateral, non-dispensing study with MiSight® 1 day and ACUVUE® Abiliti™ 1-Day; n=26 neophyte soft contact lens wearers, mean age 11.6 years (± 2.1).
7. CVI data on file 2023. Simulated retinal imagery for 3-6mm pupils when MiSight® 1 day and ACUVUE® Abiliti™ 1-Day lens optics were added to the optics of a model young eye.
8. Chamberlain P, et al. A 3-year Randomized Clinical Trial of MiSight Lenses for Myopia Control. Optom Vis Sci. 2019;96:556-567
About CooperVision
CooperVision, a division of CooperCompanies (NYSE:COO), is one of the world’s leading manufacturers of contact lenses. The company produces a full array of daily disposable, two-week and monthly soft contact lenses that feature advanced materials and optics, and premium rigid gas permeable lenses for orthokeratology and scleral designs. CooperVision has a strong heritage of addressing the toughest vision challenges such as astigmatism, presbyopia, childhood myopia, and highly irregular corneas; and offers the most complete portfolio 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 15,000 with products sold in over 130 countries. For more information, please visit www.coopercos.com
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McDougall Communications for CooperVision
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