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

30 Participants Needed

Trial Summary

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.

How is the MiSight 1 Day contact lens treatment for near-sightedness different from other treatments?

The MiSight 1 Day and NaturalVue Enhanced Multifocal 1 Day contact lenses are unique because they are designed specifically for managing near-sightedness (myopia) by using multifocal lenses, which help in focusing light correctly on the retina, potentially slowing the progression of myopia in children. Unlike traditional single-vision lenses, these multifocal lenses provide different zones for near and distance vision, offering a novel approach to myopia management. ^{1 2 3 4 5}

What is the purpose of this trial?

The purpose of this study is to compare visual performance (high and low contrast acuity, reading acuity, contrast sensitivity, stereoacuity, accommodative response, eye hand coordination, far near vision, and dynamic vision) between Visioneering Technologies, Inc. NaturalVue Multifocal and CooperVivion MiSight.

Research Team

Marjean T Kulp, O.D.

Principal Investigator

The Ohio State University College of Optometry

Eligibility Criteria

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 have had an eye exam in the last 9 months with normal stereoacuity on prior chart (or test if not available)

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

References

1. Switzerland 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. [2022]

2. England 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. [2022]

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

Treatment Outcome of Wet Age-Related Macular Degeneration Management in Thailand: A Retrospective Real-World Study (TOWER Study). [2023]

4. Czech Republic pubmed.ncbi.nlm.nih.gov

Effects of treatment change in patients with neovascular age-related macular degeneration; results from the Czech National Registry. [2016]

5. England pubmed.ncbi.nlm.nih.gov

Risk Factors for Discontinuation of Treatment for Neovascular Age-Related Macular Degeneration. [2019]