144 Participants Needed

Multifocal Contact Lenses for Near-Sightedness

(PROTECT Trial)

Recruiting at 8 trial locations
AT
Overseen ByAshley Tuan, OD, PhD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Visioneering Technologies, Inc

What You Need to Know Before You Apply

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.

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.12345

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.12367

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.12368

Who Is on the Research Team?

AT

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.
See 1 more

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
See 2 more

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?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TreatmentExperimental Treatment1 Intervention
Group II: ControlPlacebo Group1 Intervention

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

🇪🇺
Approved in European Union as NaturalVue Multifocal for:
🇺🇸
Approved in United States as NaturalVue Multifocal for:
🇨🇦
Approved in Canada as NaturalVue Multifocal for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Visioneering Technologies, Inc

Lead Sponsor

Trials
4
Recruited
280+

Published Research Related to This Trial

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

Citations

Wearer Experience and Eye Care Professional Acceptance with a 1 Day Multifocal Contact Lens. [2022]
Prospective clinical evaluation of Sunsoft Multifocal contact lens. [2017]
Randomized Crossover Trial of Silicone Hydrogel Presbyopic Contact Lenses. [2018]
A quantitative and qualitative assessment of the NOVAWET-Perception bifocal contact lens. [2017]
Multi-centre evaluation of two daily disposable contact lenses. [2019]
Clinical performance of 'no rub' multi-purpose solutions. [2005]
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]
Short-term comparison between extended depth-of-focus prototype contact lenses and a commercially-available center-near multifocal. [2022]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security