Multifocal Contact Lenses for Near-Sightedness

(PROTECT Trial)

Recruiting at 8 trial locations

Overseen By Ashley Tuan, OD, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Visioneering Technologies, Inc

Must not be taking: Atropine, Pirenzepine

Disqualifiers: Rigid lenses, Poor hygiene, others

Compensation: Varies

Number of Visits: 12

Duration: 36 months

144 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two types of contact lenses to determine which better manages near-sightedness in children. Participants will wear either single vision or multifocal contact lenses for three years to assess the impact on their vision. Children aged 7 to under 13 with mild to moderate near-sightedness and little to no astigmatism (blurred vision due to an imperfection in the eye) may be suitable for this study. As an unphased trial, this study provides a unique opportunity for participants to contribute to a better understanding of vision management options for children.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are using any myopia control treatments like bifocals, progressive lenses, or specialized contact lenses, you would need to stop those before participating.

What prior data suggests that these contact lenses are safe for near-sightedness?

Research has shown that multifocal contact lenses, such as the NaturalVue Multifocal, are safe to use. Studies have found that these lenses can slow the progression of nearsightedness in most individuals. In one study, 95% of participants experienced less worsening of their nearsightedness compared to their initial condition.

Health authorities have approved these lenses for daily use, confirming their safety. Users have not reported any unusual or severe side effects, and most people can use them without issues. Therefore, these multifocal lenses are a good option for managing nearsightedness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional single vision contact lenses that correct only one focal point, multifocal contact lenses offer a unique advantage for near-sightedness by incorporating multiple zones of vision correction in one lens. This innovative design allows users to see clearly at various distances without needing multiple pairs of glasses. Researchers are excited about multifocal lenses because they have the potential to improve visual comfort and reduce eye strain, offering a more versatile and convenient option for those with near-sightedness.

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

Research shows that multifocal contact lenses, such as the NaturalVue Multifocal, can effectively slow the progression of myopia (near-sightedness). In this trial, participants will receive either multifocal or single vision contact lenses. Studies have found that multifocal lenses significantly reduce changes in vision and eye growth, which are crucial for controlling myopia. Specifically, three studies consistently found that these lenses help manage myopia progression. Additionally, the lenses improve focus and performance for tasks requiring close vision, aiding everyday activities. Overall, existing evidence supports the effectiveness of multifocal lenses in managing myopia. ^{2 6 7 8 9}

Who Is on the Research Team?

Ashley Tuan, OD, PhD

Principal Investigator

VTI

Are You a Good Fit for This Trial?

This trial is for boys and girls aged 7 to less than 13 who have near-sightedness with specific vision criteria. They must not have worn rigid contact lenses or been in another study recently, nor used any myopia control treatments like bifocals or certain drugs.

Inclusion Criteria

Astigmatism ≤ -0.75 D

Anisometropia < 1.000

I am between 7 and 12 years old.

Exclusion Criteria

I have used treatments or wearables for nearsightedness.

Has previously worn or currently wears rigid or gas permeable contact lenses, including orthokeratology lenses

Is currently, or within 30 days prior to this study has been, an active participant in another clinical study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to wear either NaturalVue Sphere single vision contact lenses or NaturalVue Multifocal soft contact lenses

36 months

Regular visits every 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Multifocal contact lenses
• Single vision contact lenses

Trial Overview The trial tests if NaturalVue Multifocal (NVMF) soft contact lenses are more effective than single vision lenses (SVCL) at treating progressive myopia in children over three years. Participants will be randomly assigned one of the two types of lenses.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Contact lens with refractive correction, multifocal optic

Group II: Control Placebo Group 1 Intervention

Contact lens with refractive correction, single vision optic

Multifocal contact lenses is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as NaturalVue Multifocal for:

• Myopia progression control
• Refractive ametropia (myopia and hyperopia)
• Presbyopia

Approved in United States as NaturalVue Multifocal for:

• Refractive ametropia (myopia and hyperopia)
• Presbyopia

Approved in Canada as NaturalVue Multifocal for:

• Myopia progression control
• Refractive ametropia (myopia and hyperopia)
• Presbyopia

Who Is Running the Clinical Trial?

Visioneering Technologies, Inc

Lead Sponsor

Trials

4

Recruited

280+

Published Research Related to This Trial

The novel daily disposable contact lens made from verofilcon A showed superior pre-lens tear film stabilization and visual performance compared to other materials after 28 days of use in healthcare professionals, particularly under mask-wearing conditions.

Subjects using verofilcon A experienced better contrast sensitivity and longer non-invasive tear break up times, likely due to its unique surface technology and high water content, which helps maintain eye comfort and clarity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the Pre-Lens Tear Film Stability and Visual Performance of a Novel and Two Other Daily Disposable Contact Lenses in Healthcare Professionals Wearing Facial Masks for Prolonged Time. Penbe, A., Kanar, HS., Donmez Gun, R.[2022]

In a study involving 282 existing soft contact lens wearers, the 1-DAY ACUVUE lenses provided significantly higher comfort scores and longer wearing times compared to FOCUS DAILIES, indicating better overall user satisfaction.

The 1-DAY ACUVUE lenses also demonstrated superior fitting and less corneal staining, suggesting they may be a safer option for users, as less corneal staining is associated with better ocular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-centre evaluation of two daily disposable contact lenses. Walker, J., Young, G., Hunt, C., et al.[2019]

In a study involving 231 participants, the OPTI-FREE EXPRESS solution (Regimen 1) was found to provide significantly better subjective comfort and satisfaction compared to the ReNu MultiPlus solution (Regimen 2) when used with soft contact lenses.

Corneal staining was notably higher when using Regimen 2 with Group II lenses, and Group IV lenses showed significantly less residual lysozyme when cared for with Regimen 1, indicating that the choice of multi-purpose solution can impact lens care outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical performance of 'no rub' multi-purpose solutions. Stiegemeier, MJ., Cedrone, R., Evans, D., et al.[2005]

In a study involving 28 presbyopic patients, 50% successfully wore the NOVAWET-Perception multifocal contact lens, indicating a promising option for vision correction.

Among those who completed the study, 86% achieved excellent near vision (J2 or better) and 93% achieved good distance vision (20/25 or better), demonstrating the lens's efficacy in improving visual performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A quantitative and qualitative assessment of the NOVAWET-Perception bifocal contact lens. Anderson, CW., Bierly, JR., Litteral, G., et al.[2017]

In a study involving 35 presbyopic participants, the Biofinity multifocal contact lens design showed superior performance in visual tasks compared to other multifocal lenses and monovision, particularly in defocus curves, stereopsis, and subjective quality of vision.

While overall high-contrast visual acuity and reading speed were similar across lens types, the study highlighted that specific design strategies, like fitting a center-distance lens to the dominant eye, can enhance visual performance for presbyopes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Crossover Trial of Silicone Hydrogel Presbyopic Contact Lenses. Sivardeen, A., Laughton, D., Wolffsohn, JS.[2018]

In a study involving 52 participants aged 45-70, the extended depth-of-focus (EDOF) contact lenses significantly outperformed the AIR OPTIX Aqua Multifocal (AOMF) lenses in terms of near vision clarity and stereopsis, indicating better performance for presbyopes at closer distances.

Participants reported higher overall vision satisfaction and comfort with EDOF lenses compared to AOMF, with 33% preferring to purchase EDOF lenses, suggesting a favorable user experience despite no significant differences in distance vision performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term comparison between extended depth-of-focus prototype contact lenses and a commercially-available center-near multifocal. Tilia, D., Munro, A., Chung, J., et al.[2022]

In a large observational study involving 196 eye care professionals fitting 1505 presbyopic patients with stenfilcon A multifocal contact lenses, 77% of fittings were successful, indicating a high fit success rate in real-world settings.

Patient satisfaction ratings for comfort, vision, and overall satisfaction remained high (over 8 out of 10) both at the initial fitting and after 1-2 weeks of wear, with 66% of patients preferring these lenses over their previous correction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearer Experience and Eye Care Professional Acceptance with a 1 Day Multifocal Contact Lens. McParland, M., Walsh, K., Comoroda, D., et al.[2022]

In a 3-month study involving 215 patients, the Sunsoft Multifocal contact lens demonstrated good clinical performance, with 80% of patients achieving 20/25 or better binocular acuity, which significantly influenced their decision to purchase the lenses.

The study found that patients with less imbalance in monocular acuity between their eyes were more satisfied with the lenses, and there were no adverse reactions reported, indicating a safe profile for the Sunsoft Multifocal contact lens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective clinical evaluation of Sunsoft Multifocal contact lens. Key, JE., Morris, K., Mobley, CL.[2017]

Citations

1. vtivision.com vtivision.com/wp-content/uploads/2024/01/VTI-Protect-Fact-Sheet_Rv21.2_digital.pdf

PROTECT RCT Offers Data in Myopia Correction and ... The study is designed to investigate and quantify the safety and effectiveness of NaturalVue® Multifocal Contact Lenses for myopia progression control in ...

2. womeninoptometry.com womeninoptometry.com/news/article/visioneering-announces-positive-interim-2-year-data-for-their-naturalvue-multifocal-1-day-contact-lens-from-the-protect-multi-center-randomized-double-masked-clinical-trial-for-myopia-progress/

Visioneering Announces Positive Interim 2-Year Data ... The results demonstrate a significant reduction in refractive error and axial length growth compared to the control group.

3. myopiaprofile.com myopiaprofile.com/articles/naturalvue-consistent-outcomes

NaturalVue: consistent outcomes across three ... Three recent retrospective analyses show that the NaturalVue contact lens effectively slows myopia progression.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10787710/

Efficacy of Multifocal Soft Contact Lenses in Reducing Myopia ... Treatment with multifocal soft contact lenses with high peripheral add power was effective in controlling the progression of myopia and axial length elongation ...

5. reviewofmm.com reviewofmm.com/learnings-from-the-naturalvue-multifocal-protect-rct-1-year-data-set/

Learnings from the NaturalVue Multifocal PROTECT RCT 1 ... These findings suggest that NaturalVue Multifocal may enhance accommodative accuracy and near vision performance — a critical benefit in the ...

6. myopiaprofile.com myopiaprofile.com/product/naturalvue

NaturalVue® Multifocal 1 day The NaturalVue® Multifocal 1 Day lens offers an option for myopia correction and a potential for myopia control for a range of myopia prescriptions.

7. vtivision.com vtivision.com/practitioner/news/6-year-data/

6-Year Data The data showed that 95% of subjects wearing NaturalVue MF experienced a decrease in myopia progression as compared to baseline.

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf17/K173086.pdf

NaturalVue 510(k) Summary - accessdata.fda.gov NaturalVue (etafilcon A) Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ...

9. iovs.arvojournals.org iovs.arvojournals.org/article.aspx?articleid=2795147

A Randomized Controlled Trial for Myopia Progression ... - IOVS Conclusions : The highly aspheric catenary power profile contact lenses are safe and effective in reducing myopia progression and excessive axial elongation for ...