MiSight 1 Day Contact Lenses for Nearsightedness

Recruiting at 39 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

Trial Summary

What is the purpose of this trial?

This trial is testing special contact lenses called MiSight 1 Day to see if they can slow down worsening nearsightedness in children. The study will also check if the benefits last after stopping the treatment. The lenses work by changing how light enters the eye to slow down eye growth. MiSight 1 Day contact lenses have been shown to slow myopia progression in children over several years.

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.

What data supports the effectiveness of the MiSight 1 Day treatment for nearsightedness?

Research shows that MiSight contact lenses can effectively control the progression of myopia (nearsightedness) by reducing contrast in the peripheral vision, which may help slow down the worsening of vision over time. ^{1 2 3 4 5}

How is the MiSight 1 Day treatment different from other treatments for nearsightedness?

MiSight 1 Day contact lenses are unique because they use a dual-focus design to slow the progression of nearsightedness in children, unlike traditional single-vision lenses that only correct vision. These lenses are worn daily and disposed of after each use, offering a convenient and effective way to manage myopia. ^{2 3 4 6 7}

Research Team

William Gleason, OD

Principal Investigator

Foresight Regulatory Strategies, Inc. (FRS)

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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 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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Comparison of optical myopia control interventions: effect on peripheral image quality and vision. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

MiSight Assessment Study Spain: Adverse Events, Tear Film Osmolarity, and Discontinuations. [2018]

3. United States 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. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Six years of wearer experience in children participating in a myopia control study of MiSight® 1 day. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Foveal and peripheral visual quality and accommodation with multifocal contact lenses. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Long-term Effect of Dual-focus Contact Lenses on Myopia Progression in Children: A 6-year Multicenter Clinical Trial. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Vision performance with a contact lens designed to slow myopia progression. [2022]