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Multifocal Contact Lenses for Near-Sightedness (PROTECT Trial)

N/A
Recruiting
Research Sponsored by Visioneering Technologies, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female, aged 7 to <13 (inclusive) at the Screening/Baseline examination
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline,12, 24, 36 months
Awards & highlights

PROTECT Trial Summary

This trial is testing two types of contact lenses to see which is better. One group will wear single vision lenses and the other will wear multifocal lenses. The trial will last for three years.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While the exact side effects aren't listed, wearing contact lenses can cause eye discomfort, dryness, redness, blurred vision, and a risk of infection. The multifocal lens may also affect how children perceive depth.

PROTECT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 7 and 12 years old.

PROTECT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline,12, 24, 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline,12, 24, 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Refractive Error relative to Baseline
Secondary outcome measures
Change in Axial Length

PROTECT Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TreatmentExperimental Treatment1 Intervention
Contact lens with refractive correction, multifocal optic
Group II: ControlPlacebo Group1 Intervention
Contact lens with refractive correction, single vision optic
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Multifocal contact lenses
2016
N/A
~40

Find a Location

Who is running the clinical trial?

Visioneering Technologies, IncLead Sponsor
2 Previous Clinical Trials
130 Total Patients Enrolled
Ashley Tuan, OD, PhDStudy ChairVTI
1 Previous Clinical Trials
40 Total Patients Enrolled

Media Library

Multifocal contact lenses Clinical Trial Eligibility Overview. Trial Name: NCT05159765 — N/A
Near-sightedness Research Study Groups: Control, Treatment
Near-sightedness Clinical Trial 2023: Multifocal contact lenses Highlights & Side Effects. Trial Name: NCT05159765 — N/A
Multifocal contact lenses 2023 Treatment Timeline for Medical Study. Trial Name: NCT05159765 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age range of applicants for this trial exceeding 40 years?

"This trial has specific age restrictions, with the minimum being 7 years old and the maximum set at 13."

Answered by AI

Who meets the eligibility criteria for enrolling in this clinical investigation?

"The current clinical trial is looking for 144 children aged 7-13 with progressive myopia to participate. The application requirements are gender neutral, must have astigmatism not exceeding -0.75 diopters, a spherical equivalent refractive error between -0.75 and -5.00 diopters inclusive, and anisometropia of less than 1.000 diopters"

Answered by AI

Is enrollment available for this experiment?

"Affirmative. According to clinicaltrials.gov, this research is recruiting participants since its initial post on January 22nd 2022 and the most recent update was October 3rd of that same year. The team needs 144 enrollees based in seven different locations."

Answered by AI

In how many locations is this research investigation being conducted?

"Cooper Eye Care in New york, Fig Garden Optometry in Fresno, and Toronto Eye Care in Toronto are three of the seven sites currently enrolling patients for this trial. The other four locations remain unnamed."

Answered by AI

How many participants has this research trial accumulated thus far?

"To progress this medical study, 144 patients that meet the specified inclusion criteria need to take part. Cooper Eye Care in New york and Fig Garden Optometry in Fresno, California are two of many sites offering their services for this clinical trial."

Answered by AI

Who else is applying?

What state do they live in?
New York
What portion of applicants met pre-screening criteria?
Met criteria
~55 spots leftby Aug 2025