Multifocal Contact Lenses for Near-sightedness

(ViPCD3 Trial)

Overseen By Douglas P. Benoit, OD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Visioneering Technologies, Inc

Must not be taking: Corticosteroids, Antimetabolites

Disqualifiers: Autoimmune, Diabetes, Lazy eye, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two types of multifocal contact lenses to determine which better aids those with near-sightedness in various conditions, such as reading or moving around. The trial tests MiSight 1 Day and NaturalVue Enhanced Multifocal 1 Day lenses, aiming to identify which lenses best improve vision clarity, contrast, and eye coordination. Suitable participants have previously worn contact lenses, have had an eye exam in the last nine months, and possess normal vision without any eye diseases. As an unphased trial, this study provides a unique opportunity to contribute to understanding which lenses might enhance daily vision experiences.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you use eye medications that interfere with contact lens wear, you may not be eligible to participate.

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

Research shows that both MiSight 1 Day and NaturalVue Enhanced Multifocal 1 Day contact lenses are safe and comfortable for children with myopia (nearsightedness).

For MiSight 1 Day lenses, studies indicate that more than 80% of children continue using them, suggesting ease of wear. Children have used these lenses for up to six years without major safety concerns.

The NaturalVue Enhanced Multifocal 1 Day lenses also demonstrate good safety results. One study showed they improved vision by reducing refractive error by 69% and the eye's length by 59%, with no serious side effects reported. This indicates that children generally did not experience harmful effects while wearing these lenses.

Both types of lenses appear to be safe options for children needing help with myopia. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because both MiSight 1 Day and NaturalVue Enhanced Multifocal 1 Day contact lenses offer innovative approaches to managing near-sightedness. MiSight lenses are unique because they incorporate a specific optical design that can slow the progression of myopia in children, potentially reducing the risk of future eye complications. On the other hand, NaturalVue lenses use a patented design that enhances depth of focus, which may improve clarity and comfort for near-sighted individuals. These advancements present promising alternatives to traditional single-vision corrective lenses, providing more comprehensive solutions for managing near-sightedness.

What evidence suggests that this trial's treatments could be effective for near-sightedness?

This trial will compare MiSight 1 Day contact lenses with NaturalVue Enhanced Multifocal 1 Day contact lenses for managing nearsightedness. Studies have shown that MiSight 1 Day contact lenses effectively slow the worsening of nearsightedness (myopia) in children, reducing its progression by an average of 59% over three years. Similarly, NaturalVue Multifocal 1 Day contact lenses have demonstrated positive results, with 95% of users experiencing slower myopia progression over six years compared to before using the lenses. Both types of lenses aim to manage myopia by slowing its worsening over time. ^{2 5 6 7 8}

Who Is on the Research Team?

Marjean T Kulp, O.D.

Principal Investigator

The Ohio State University College of Optometry

Are You a Good Fit for This Trial?

This trial is for individuals with near-sightedness who want to try new daily disposable multifocal lenses. Specific eligibility criteria are not provided, but typically participants should have a stable prescription and no eye diseases.

Inclusion Criteria

Participants must sign written Informed Consent/Assent

Participants must have a Spherical Equivalent glasses prescription between -0.50 to -7.00 diopters (D), Astigmatism ≤ -0.75D, Anisometropia ≤ 1.00D

Participants must, on examination, have ocular findings considered to be within normal limits

Exclusion Criteria

Current hard lens wearers

Currently enrolled in an ophthalmic clinical trial that could negatively impact corneal or conjunctival health in this trial

I have not had eye surgery or an eye injury in the last 12 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Visioneering Technologies, Inc. NaturalVue Multifocal or CooperVision MiSight contact lenses to compare visual performance

8 weeks

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 contact lens
• NaturalVue Enhanced Multifocal 1 Day contact lens

Trial Overview The study compares visual performance using two types of contact lenses: NaturalVue Enhanced Multifocal and MiSight. It measures clarity at different contrasts, reading ability, depth perception, focus changes, hand-eye coordination, and vision stability.

How Is the Trial Designed?

Group I: MiSight Active Control 1 Intervention

MiSight 1 Day contact lens

Group II: NaturalVue Active Control 1 Intervention

NaturalVue Enhanced Multifocal 1 Day contact lens

MiSight 1 Day contact lens is already approved in United States, European Union for the following indications:

Approved in United States as MiSight 1 Day for:

• Correction of myopic ametropia and slowing the progression of myopia in children with non-diseased eyes, who at the initiation of treatment are 8-12 years of age and have a refraction of -0.75 to -4.00 diopters (spherical equivalent) with ≤0.75 diopters of astigmatism.

Approved in European Union as MiSight 1 Day for:

• Myopia control in children

Who Is Running the Clinical Trial?

Visioneering Technologies, Inc

Lead Sponsor

Trials

4

Recruited

280+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

Published Research Related to This Trial

In a study of 203 eyes treated with VEGF inhibitors (bevacizumab and ranibizumab) for myopic choroidal neovascularization over 24 months, patients experienced an average visual improvement of +8 letters, indicating effective treatment outcomes.

Both bevacizumab and ranibizumab showed similar efficacy and safety profiles, with a median of three injections primarily in the first year, suggesting that either drug can be a viable option for treating this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vascular endothelial growth factor inhibitors for predominantly Caucasian myopic choroidal neovascularization: 2-year treatment outcomes in clinical practice: data from the Fight Retinal Blindness! Registry. Gabrielle, PH., Nguyen, V., Creuzot-Garcher, C., et al.[2022]

In a 12-month extension study involving 139 patients with neovascular age-related macular degeneration, both the treat-and-extend (T&E) regimen and those switched from once-monthly (OM) dosing to T&E maintained visual acuity improvements achieved at 24 months, with mean changes of +6.6 letters and +4.8 letters respectively.

The number of injections required during the extension period was similar for both groups, averaging around 7.3 for T&E and 7.1 for OM-T&E, indicating that the T&E regimen is effective in maintaining visual gains without increasing treatment burden.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Efficacy of a Treat-and-Extend Regimen with Ranibizumab in Patients with Neovascular Age-Related Macular Disease: An Open-Label 12-Month Extension to the CANTREAT Study. Kertes, PJ., Sheidow, T., Williams, G., et al.[2022]

In a study of 932 patients with neovascular age-related macular degeneration (nAMD), 50.9% discontinued treatment within the first year, highlighting a significant challenge in managing this condition.

Patients with lower visual acuity, serious comorbidities, or those treated with ranibizumab were at a higher risk of discontinuation, suggesting that aflibercept may be a better option for those at risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk Factors for Discontinuation of Treatment for Neovascular Age-Related Macular Degeneration. Westborg, I., Rosso, A.[2019]

In a study of 572 eyes with neovascular age-related macular degeneration (nAMD) treated with anti-VEGF injections, patients showed a significant mean improvement in visual acuity of six letters after 12 months, along with a notable reduction in central retinal thickness.

Despite initial improvements, long-term follow-up revealed persistent disease activity in about half of the patients, with only minimal visual improvement by 36 months, highlighting challenges in treatment adherence and the need for better management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment Outcome of Wet Age-Related Macular Degeneration Management in Thailand: A Retrospective Real-World Study (TOWER Study). Thoongsuwan, S., Hanutsaha, P., Chantarasorn, Y., et al.[2023]

In a study of 750 patients with neovascular AMD, 7.7% of those treated with ranibizumab required a change in treatment, compared to 20.5% with pegaptanib and 22% with PDT and verteporfin, indicating ranibizumab may be more effective as a secondary treatment.

Patients experienced an average loss of 7.7 letters in visual acuity (BCVA) during the first 6 months, but this decline slowed significantly in the following 6 months, especially in those who switched to ranibizumab after pegaptanib treatment failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of treatment change in patients with neovascular age-related macular degeneration; results from the Czech National Registry. Studnicka, J., Rencova, E., Rozsival, P., et al.[2016]

Citations

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

Five things we know about MiSight 1 day The MiSight 1 day retention rate was 81% (109 of 135) in Part 1 and 85% (92 of 108) in Part 2, indicating that the majority of children ...

2. coopervision.com coopervision.com/our-company/news-center/press-release/published-study-peer-reviewed-journal-confirms-lasting-myopia

Published Study in Peer-Reviewed Journal Confirms ... The results showed that children retained the benefits of myopia control without experiencing accelerated myopia progression post-treatment. “ ...

3. 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.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31343513/

A 3-year Randomized Clinical Trial of MiSight Lenses for ... Results of this clinical trial demonstrate the effectiveness of the MiSight daily disposable soft contact lens in slowing change in spherical equivalent ...

5. misight.com misight.com/blog/how-do-misight-1-day-contact-lenses-work

How Do MiSight® 1 Day Contact Lenses Work? Over the initial three years of the study, MiSight® 1 day slowed myopia progression in children by 59% on average,†1 and 41% of eyes had no progression.|2 ...

6. 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 ...

7. misight.com misight.com/

MiSight® 1 day for myopia control | CooperVision Children wearing MiSight® 1 day achieved better than 20/20 vision across all visits over a 6-year period.**1,3. Help protect their precious vision from getting ...

8. coopervision.com coopervision.com/our-company/news-center/press-release/coopervision-presents-six-year-data-misight-1-day-study

CooperVision Presents Six-Year Data from MiSight® 1 Day ... Nearly one in four children's eyes originally fit with MiSight 1 day remain stable for myopia after six years.