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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

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.
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.
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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Refractive Error relative to Baseline
Secondary study objectives
Change in Axial Length

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
3 Previous Clinical Trials
134 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
~24 spots leftby Aug 2025
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