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

Trial Summary

What is the purpose of this trial?

This is a multi-center, randomized, double-masked clinical trial. All study devices are market approved/cleared in the localities where the study is conducted. Subjects will be randomly assigned to wear NaturalVue Sphere single vision contact lenses (SVCL) or NaturalVue Multifocal (NVMF) soft contact lenses for a total of three years.

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 data supports the effectiveness of the treatment Multifocal contact lenses for near-sightedness?

The research on similar multifocal contact lenses, like the Sunsoft Multifocal and MyDay multifocal, shows positive wearer experiences and acceptance by eye care professionals, suggesting that multifocal lenses can be effective for vision correction. ^{1 2 3 4 5}

Is it safe to use multifocal contact lenses for near-sightedness?

The research does not provide specific safety data for multifocal contact lenses for near-sightedness, but it does mention evaluations of similar contact lenses for comfort and performance, which are generally important for safety. No adverse safety issues are highlighted in the studies. ^{1 4 5 6 7}

How do multifocal contact lenses differ from other treatments for near-sightedness?

Multifocal contact lenses, like the NaturalVue Multifocal, are unique because they are designed to provide clear vision at multiple distances, which can be beneficial for people who need help seeing both near and far. Unlike single vision contact lenses that correct only for one distance, these lenses can help reduce the need for additional reading glasses. ^{1 3 4 5 8}

Research Team

Ashley Tuan, OD, PhD

Principal Investigator

VTI

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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 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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Wearer Experience and Eye Care Professional Acceptance with a 1 Day Multifocal Contact Lens. [2022]

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

Prospective clinical evaluation of Sunsoft Multifocal contact lens. [2017]

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

Randomized Crossover Trial of Silicone Hydrogel Presbyopic Contact Lenses. [2018]

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

A quantitative and qualitative assessment of the NOVAWET-Perception bifocal contact lens. [2017]

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

Multi-centre evaluation of two daily disposable contact lenses. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Clinical performance of 'no rub' multi-purpose solutions. [2005]

7. New Zealand 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. [2022]

8. Spain pubmed.ncbi.nlm.nih.gov

Short-term comparison between extended depth-of-focus prototype contact lenses and a commercially-available center-near multifocal. [2022]