MiSight 1 Day Contact Lenses for Near-sightedness
Recruiting in Palo Alto (17 mi)
+50 other locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: CooperVision International Limited (CVIL)
Must not be taking: Myopia control drugs
Disqualifiers: Eye infections, Dry eyes, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?The purpose of this post-approval study is to confirm the safety of daily disposable soft contact lens wear among the intended patient population for the MiSight 1 Day lens in the US.
Will I have to stop taking my current medications?
If you are taking medications that interfere with contact lens wear or using any drugs to control nearsightedness, you cannot participate in the study.
What data supports the effectiveness of the MiSight 1 Day treatment for near-sightedness?
Research shows that MiSight contact lenses can help control the progression of myopia (near-sightedness) by affecting peripheral vision and reducing contrast in the peripheral visual field. This change in peripheral vision is believed to play a role in slowing down the worsening of myopia.
12345How is the MiSight 1 Day treatment different from other treatments for near-sightedness?
MiSight 1 Day contact lenses are unique because they use a dual-focus design specifically to slow the progression of myopia (near-sightedness) in children, unlike regular single-vision lenses that only correct vision. These lenses are daily disposables, which can be more convenient and hygienic compared to other contact lenses that require cleaning and storage.
23567Eligibility Criteria
This trial is for children aged 8-12 with near-sightedness, who can wear contact lenses for about 10 hours a day and have good overall eye health. They must not have severe dry eyes, infections, or diseases affecting the eyes and must be able to handle lenses properly.Inclusion Criteria
Best-corrected visual acuity by manifest refraction of at least 20/25 bilaterally
I am between 8 and 12 years old.
Anisometropia: ≤ 1.50D SERE
+7 more
Exclusion Criteria
I have recent or ongoing eye inflammation or infection.
My cornea is less sensitive to touch, and I am not aphakic.
I have an eye condition affecting my cornea, conjunctiva, or eyelids.
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive the MiSight 1 Day lenses and are monitored for safety
3 years
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests the safety of MiSight 1 Day disposable soft contact lenses in young patients within the US. It aims to confirm that these lenses are safe for daily use among kids who meet specific vision criteria.
1Treatment groups
Experimental Treatment
Group I: MiSight 1 DayExperimental Treatment1 Intervention
MiSight 1 Day
MiSight 1 Day is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as MiSight 1 Day for:
- Myopia control in children aged 8-12 years old
🇪🇺 Approved in European Union as MiSight 1 Day for:
- Myopia control in children aged 8-12 years old
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Centerton Family EyecareCenterton, AR
Gulf Coast Eye CenterSarasota, FL
Weston Contact Lens Institute LLCWeston, FL
Darien Eye SpecialistsDarien, IL
More Trial Locations
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Who Is Running the Clinical Trial?
CooperVision International Limited (CVIL)Lead Sponsor
Coopervision, Inc.Lead Sponsor
References
Comparison of optical myopia control interventions: effect on peripheral image quality and vision. [2023]This study compares the effects on peripheral vision and image quality of four myopia control interventions: a) Perifocal spectacles/ArtOptica, b) Stellest spectacles/Essilor), c) MiyoSmart spectacles/Hoya and d) MiSight contact lenses/CooperVision. Five subjects participated with habitual or no correction as reference. Three techniques were used: 1) Hartmann-Shack sensors for wavefront errors, 2) double-pass imaging system for point-spread-functions (PSF), and 3) peripheral acuity evaluation. The results show that multiple evaluation methods are needed to fully quantify the optical effects of these myopia control interventions. Perifocal was found to make the relative peripheral refraction (RPR) more myopic in all subjects and to interact with the natural optical errors of the eye, hence showing larger variations in the effect on peripheral vision. MiSight had a smaller effect on RPR, but large effect on peripheral vision. Stellest and MiyoSmart also showed small effects on RPR but had broader double-pass PSFs for all participants, indicating reduced retinal contrast. Reduction in peripheral retinal contrast might thereby play a role in slowing myopia progression even when the peripheral refraction does not turn more myopic.
MiSight Assessment Study Spain: A Comparison of Vision-Related Quality-of-Life Measures Between MiSight Contact Lenses and Single-Vision Spectacles. [2018]Recent research has shown that concentric contact lenses (CLs) can be a way to control the progression of myopia. The purpose of the current study was to compare vision-related quality-of-life measures in children wearing distance single-vision (SV) spectacles versus MiSight CLs, a specific concentric design for myopia control.
Six years of wearer experience in children participating in a myopia control study of MiSight® 1 day. [2023]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.
Foveal and peripheral visual quality and accommodation with multifocal contact lenses. [2022]Multifocal contact lenses are increasingly popular interventions for controlling myopia. This study presents the short-term effects of multifocal contact lenses on foveal and peripheral vision. The MiSight contact lenses designed to inhibit myopia progression and the 1-Day Acuvue Moist contact lenses designed for presbyopia were investigated. The MiSight produced similar foveal results to spectacles despite the increased astigmatism and coma. The MiSight also reduced the low-contrast resolution acuity in the periphery, despite no clear change in relative peripheral refraction. When compared with spectacles, Acuvue Moist decreased accommodative response and reduced foveal high- and low-contrast resolution acuity, whereas peripheral thresholds were more similar to those of spectacles. The most likely treatment property for myopia control by the MiSight is the contrast reduction in the peripheral visual field and the changed accommodation.
MiSight Assessment Study Spain: Adverse Events, Tear Film Osmolarity, and Discontinuations. [2018]To assess the relative clinical success of MiSight contact lenses (CLs) (study group) and distance single-vision (SV) spectacles (control group) in children in terms of adverse events (AEs), discontinuations, and tear film osmolarity over a 2-year period.
Clinical and overnight corneal swell comparison of the 1-Day Acuvue lens versus the Medalist, Surevue, Biomedics, and Acuvue lenses. [2017]We characterized the clinical performance of the 1-Day Acuvue contact lens by direct comparison with four frequently prescribed daily wear lenses.
Vision performance with a contact lens designed to slow myopia progression. [2022]Recent research suggests multizone/dual-focus (DF) lens corrections may aid in controlling the progression of myopia. Recently, such a soft contact lens has become commercially available in Hong Kong (MiSight, CooperVision). The purpose of the current study was to evaluate the visual acceptability of this new lens design.