MiSight 1 Day Contact Lenses for Nearsightedness

Recruiting at 40 trial locations

Overseen By Laura Rosanova-Philipp, O.D.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: CooperVision, Inc.

Must not be taking: Myopia control, Systemic, Topical

Disqualifiers: Ocular disease, Dry eyes, Keratoconus, 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

900 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to confirm the effectiveness of a special daily contact lens, MiSight 1 Day, in reducing nearsightedness (myopia) and to assess the stability of results over a year. The study will compare these lenses with another type of daily contact lens. It seeks children aged 8-12 with mild to moderate nearsightedness who are interested in wearing contact lenses most days of the week. Participants should not have used other myopia treatments or have eye conditions like severe dry eyes or infections. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research in managing myopia in children.

Do I need to stop my current medications to join the trial?

The trial requires that you do not use any medications that might interfere with contact lens wear, pupil size, or refractive state. If you are using such medications, you may need to stop them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that MiSight 1 Day contact lenses are safe and comfortable for children. Studies have found that children as young as 8 years old can wear these lenses without major problems. The FDA has approved the lenses, indicating they have been tested for safety and effectiveness. Over several years, no serious issues have been reported. While all treatments carry some risks, MiSight 1 Day lenses have a strong safety record based on the available evidence. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

MiSight 1 Day contact lenses are unique because they are specifically designed to slow the progression of nearsightedness, also known as myopia, in children. Unlike standard corrective lenses that simply improve vision, MiSight lenses use a special optical design to alter how light enters the eye, potentially reducing the eye's elongation, which is a key factor in worsening myopia. Researchers are excited about these lenses because they offer a proactive approach, not just correcting vision but also addressing the underlying progression of the condition, which could lead to long-term benefits for eye health.

What evidence suggests that MiSight 1 Day contact lenses are effective for nearsightedness?

Research shows that MiSight 1 Day contact lenses, one of the treatments in this trial, can slow the worsening of nearsightedness in children. Studies have found that these lenses reduce the progression of nearsightedness by 59%, with 0.73 diopters less change in vision compared to regular lenses over three years. Additionally, MiSight lenses result in 52% less eye growth, which is crucial because more eye growth can worsen nearsightedness. Over six years, these lenses have cut eye growth by more than half compared to untreated eyes. This evidence supports using MiSight 1 Day lenses as a promising way to manage nearsightedness in children. Participants in this trial may receive MiSight 1 Day lenses or Proclear 1 Day lenses, which serve as an active comparator. ^{2 4 6 7 8}

Who Is on the Research Team?

William Gleason, OD

Principal Investigator

Foresight Regulatory Strategies, Inc. (FRS)

Are You a Good Fit for This Trial?

This trial is for children aged 8-12 with near-sightedness, having a specific range of vision error and good overall health. They must be willing to wear contact lenses daily for about 10 hours, follow the study's schedule for 4 years, and not have any eye diseases or conditions that could interfere with contact lens use.

Inclusion Criteria

Astigmatism: ≤ 0.75 D

Manifest Refraction - Spherical Equivalent Refractive Error (SERE) at baseline between -0.75 D and -4.00 D inclusive (at the corneal plane) in each eye

My eyes are healthy and free from any diseases or scars.

Exclusion Criteria

I have used treatments to control my nearsightedness.

I have a history of eye conditions or allergies that could be worsened by contact lenses.

I don't use eye medications or artificial tears that affect wearing contact lenses.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Participants wear MiSight 1 Day lenses or Proclear 1 day lenses to study the effectiveness in slowing myopia progression

3 years

Post-Treatment Part 2

Participants wear Proclear 1 day lenses to study the stability of the effectiveness result over a one-year post-treatment period

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• MiSight 1 Day
• Proclear 1 day

Trial Overview

The MiSight 1 Day contact lens is being tested against Proclear 1 day lenses to confirm its effectiveness in reducing myopia in kids when used in everyday life. The study will monitor changes over one year post-treatment.

How Is the Trial Designed?

Group I: MiSight 1 day Experimental Treatment 1 Intervention

MiSight 1 day

Group II: Proclear 1 day Active Control 1 Intervention

Proclear 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 use of dual-focus soft contact lenses (MiSight 1 day) effectively slowed the progression of myopia in children over a 6-year period, demonstrating sustained efficacy after initial treatment.

Children who switched from single vision lenses to dual-focus lenses experienced a significant 71% reduction in eye growth over the next 3 years, indicating that early treatment can have lasting benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term Effect of Dual-focus Contact Lenses on Myopia Progression in Children: A 6-year Multicenter Clinical Trial. Chamberlain, P., Bradley, A., Arumugam, B., et al.[2023]

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 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]

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 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]

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 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.

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.

2.

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.

3.

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 ...

4.

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 ...

5.

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.

6.

misight.com

misight.com/

MiSight® 1 day for myopia control | CooperVision

On average, age-appropriate children wearing MiSight® 1 day contact lenses progressed less than -1.00D over 6 years.|3. Children as young as 8 years old can ...

7.

accessdata.fda.gov

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

summary of safety and effectiveness data (ssed)

MiSight 1 Day lenses correct myopia and slow its progression in children 8-12 years old with -0.75 to -4.00 D refraction and ≤ 0.75 diopters of ...

8.

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.