MiSight 1 Day Contact Lenses for Near-sightedness

Recruiting at 50 trial locations

Overseen By Kathryn Richdale, OD, PhD

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

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. ^{1 2 3 4 5}

How 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. ^{2 3 5 6 7}

Research Team

William Gleason, OD

Principal Investigator

Foresight Regulatory Strategies

Eligibility 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

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

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

Treatment Details

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.

Participant Groups

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

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]

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]

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 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]

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: A Comparison of Vision-Related Quality-of-Life Measures Between MiSight Contact Lenses and Single-Vision Spectacles. [2018]

3. England pubmed.ncbi.nlm.nih.gov

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

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

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

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

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

6. United States 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. [2017]

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

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