MiSight 1 Day Contact Lenses for Near-sightedness

Recruiting at 55 trial locations

Overseen By Sara Chiu, OD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: CooperVision, Inc.

Must not be taking: Myopia control drugs

Disqualifiers: Eye infections, Dry eyes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 3 years

2400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests MiSight 1 Day contact lenses to ensure their safety for children who are near-sighted, meaning they have difficulty seeing distant objects. The main goal is to confirm the safety of these daily disposable lenses for children. Kids aged 8 to 12 who need glasses for clear distance vision and wish to try contact lenses might be suitable participants. The trial requires wearing these lenses for about 10 hours a day, six days a week. As an unphased trial, this study provides a unique opportunity for children to experience the benefits of contact lenses while contributing to important safety research.

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 prior data suggests that MiSight 1 Day contact lenses are safe for near-sightedness?

Research has shown that MiSight 1 Day contact lenses are safe and comfortable. These lenses have the most extensive data on safety and effectiveness among soft contact lenses for nearsightedness.

Studies confirm that MiSight 1 Day is the first and only contact lens approved by the FDA to slow the progression of nearsightedness in children aged 8-12. This approval is based on thorough research proving the lenses are safe for daily use.

In summary, MiSight 1 Day lenses are designed specifically for young users and have a strong safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for near-sightedness, like glasses and standard contact lenses, work by correcting vision but don't address the progression of the condition. MiSight 1 Day contact lenses are unique because they are designed to slow down the progression of near-sightedness, also known as myopia, in children. These lenses use a special dual-focus design that not only corrects vision but also creates a treatment zone to reduce the growth of the eye that leads to worsening myopia. Researchers are excited about this treatment because it offers a potential dual benefit—clear vision today and healthier eyes in the future.

What is the effectiveness track record for MiSight 1 Day contact lenses for near-sightedness?

Research has shown that MiSight 1 Day contact lenses, which participants in this trial will use, can slow the worsening of near-sightedness (myopia) in children. Studies have found that these lenses reduce the progression of myopia by 59%, meaning children's vision changes less over time. They also slow the eye's growth by 52%, helping to maintain healthier eyes. Over six years, children using MiSight 1 Day lenses demonstrated less eye growth compared to those not using them. This evidence supports MiSight 1 Day as an effective choice for managing near-sightedness in kids. ^{6 7 8 9 10}

Who Is on the Research Team?

William Gleason, OD

Principal Investigator

Foresight Regulatory Strategies

Are You a Good Fit for This Trial?

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

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• MiSight 1 Day

Trial Overview 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.

How Is the Trial Designed?

Group I: MiSight 1 Day Experimental Treatment 1 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

Who Is Running the Clinical Trial?

CooperVision, Inc.

Lead Sponsor

CooperVision International Limited (CVIL)

Lead Sponsor

Trials

171

Recruited

14,600+

Dr. Patrizia Cavazzoni

CooperVision International Limited (CVIL)

Chief Medical Officer

MD from Harvard Medical School

Steven Robins

CooperVision International Limited (CVIL)

President, Americas

Bachelor of Arts from Bates College, participated in Pfizer Global Leadership Program with Harvard University

Coopervision, Inc.

Lead Sponsor

Trials

164

Recruited

14,200+

Steven Robins

Coopervision, Inc.

Chief Executive Officer

Bachelor of Arts from Bates College, Pfizer Global Leadership Program with Harvard University

Dr. Patrizia Cavazzoni

Coopervision, Inc.

Chief Medical Officer

MD from Harvard Medical School

Published Research Related to This Trial

The MiSight multifocal contact lenses effectively maintain foveal vision similar to spectacles while potentially controlling myopia progression, although they may reduce low-contrast resolution in peripheral vision.

In contrast, the 1-Day Acuvue Moist lenses showed decreased accommodative response and reduced foveal acuity compared to spectacles, but their peripheral vision performance was comparable to that of spectacles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Foveal and peripheral visual quality and accommodation with multifocal contact lenses. Papadogiannis, P., Romashchenko, D., Vedhakrishnan, S., et al.[2022]

Children aged 8 to 12 wearing MiSight concentric contact lenses reported significantly better vision-related quality of life compared to those wearing single-vision spectacles, particularly in areas like appearance, satisfaction, and peer perceptions, based on a study of 74 participants over 24 months.

While MiSight lenses improved overall quality of life, they did not provide better near vision compared to single-vision spectacles, indicating a trade-off in visual performance for myopia control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MiSight Assessment Study Spain: A Comparison of Vision-Related Quality-of-Life Measures Between MiSight Contact Lenses and Single-Vision Spectacles. Pomeda, AR., Pérez-Sánchez, B., Cañadas Suárez, MDP., et al.[2018]

In a study involving 48 patients over 2 weeks, the 1-Day Acuvue contact lens was found to be less preferred compared to Medalist, Surevue, and Biomedics 55 lenses among non-allergic patients, highlighting the importance of lens comfort and handling in overall preference.

For patients with allergies, the 1-Day Acuvue lens showed no significant preference compared to other lenses, indicating that comfort is the primary factor influencing their choice, while corneal swelling was similar between the 1-Day Acuvue and Medalist lenses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and overnight corneal swell comparison of the 1-Day Acuvue lens versus the Medalist, Surevue, Biomedics, and Acuvue lenses. Bucci, FA., Myers, PJ., Evans, RE., et al.[2017]

In a study of 74 children aged 8 to 12, MiSight contact lenses were found to be a safe option for myopia correction, with no serious or significant adverse events reported over a 2-year period.

While there were some nonsignificant adverse events and a few discontinuations in the MiSight group, the overall safety profile was comparable to that of distance single-vision spectacles, indicating that both options are effective for managing myopia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MiSight Assessment Study Spain: Adverse Events, Tear Film Osmolarity, and Discontinuations. Ruiz-Pomeda, A., Pérez-Sánchez, B., Prieto-Garrido, FL., et al.[2018]

In a 6-year study involving 135 myopic children aged 8-12, those wearing MiSight® 1 day dual-focus contact lenses reported high satisfaction levels in handling, comfort, and vision, with over 97% expressing overall satisfaction.

The MiSight® 1 day lenses effectively controlled myopia without negatively impacting the children's subjective experiences, and participants adapted quickly to wearing them full-time, showing increased wear times over the study period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Six years of wearer experience in children participating in a myopia control study of MiSight® 1 day. Lumb, E., Sulley, A., Logan, NS., et al.[2023]

The study evaluated four myopia control interventions using multiple methods, revealing that Perifocal spectacles increased myopic peripheral refraction in all subjects, leading to greater variability in peripheral vision effects.

MiSight contact lenses showed a smaller impact on peripheral refraction but significantly improved peripheral vision, while Stellest and MiyoSmart spectacles had minor effects on refraction but reduced retinal contrast, which may help slow myopia progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of optical myopia control interventions: effect on peripheral image quality and vision. Papadogiannis, P., Börjeson, C., Lundström, L.[2023]

The study evaluated the visual acceptability of the MiSight dual-focus contact lenses in 24 young adults, finding that they provide good distance acuity comparable to standard multifocal lenses.

While the MiSight lenses are effective in maintaining visual acuity, users may experience some decrease in visual performance, particularly in low illumination and low contrast conditions, similar to other multifocal lenses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vision performance with a contact lens designed to slow myopia progression. Kollbaum, PS., Jansen, ME., Tan, J., et al.[2022]

Citations

1. coopervision.com coopervision.com/sites/coopervision.com/files/MiSight%207-Year%20Clinical%20Fact%20Sheet_Final_14740_5.28.2023-.pdf

MiSight 1 day Objective: Quantify the effectiveness of MiSightR 1 day in slowing the rate of myopia progression compared to a single vision 1-day lens over a 3-year period.

2. myopiaprofile.com myopiaprofile.com/articles/five-things-we-know-about-misight

Five things we know about MiSight 1 day 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 ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37897105/

Six-year cumulative treatment effect and treatment efficacy ... Results: When compared to the predicted accumulated growth of untreated eyes, 6 years of treatment reduced growth by 0.52 mm, while 3 years of ...

4. coopervision.com coopervision.com/our-company/news-center/press-release/peer-review-paper-verifies-misight-1-day-six-year-study

Peer Review Paper Verifies MiSight® 1 day Six-Year Study ... MiSight® 1 day slowed eye growth to less than half that observed in untreated children, paralleling modelled rates of emmetropic eye growth.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05285553

NCT05285553 | MiSight 1 Day Post-Approval Study for ... The purpose of this post-approval study is to confirm the effectiveness of the MiSight 1 Day lens in clinical practices within the US.

6. coopervision.com coopervision.com/contact-lenses/misight-1-day

MiSight® 1 day The FIRST and ONLY FDA-approved soft contact lens proven to slow the progression of myopia (nearsightedness) in children, aged 8-12 at the initiation of ...

7. misight.com misight.com/frequently-asked-questions

Frequently asked questions | MiSight® 1 day MiSight 1 day soft contact lenses are specifically designed for myopia control and are FDA approved to slow the progression of myopia in children aged 8-12.

8. myopiaprofile.com myopiaprofile.com/product/MiSight-1-day

MiSight 1-day MiSight 1 day is safe, well-tolerated, and has the longest and most robust data available on its safety and efficacy of any soft contact lens option for myopia ...

9. coopervision.com coopervision.com/myopia-management

Myopia Management MiSight 1 day contact lenses are the first and ONLY soft contact lenses that are FDA approved to slow the progression of myopia in children 8-12 years of age.

10. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf18/P180035B.pdf

summary of safety and effectiveness data (ssed) Do not use the MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily. Wear when any of the following conditions exist: o Acute ...