MyopiaPROTECTNCT05159765
Progressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial
A study testing Single vision contact lenses and Multifocal contact lenses in people with Myopia, run by Visioneering Technologies, Inc at 8 sites in 4 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 7 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Single vision contact lenses and Multifocal contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 8 sitesin 4 countries
- Study dates
- 22 Jan 2022to Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male or female, aged 7 to <13 (inclusive) at the Screening/Baseline examination.
- Meet the following refractive criteria determined by cycloplegic autorefraction at Screening/Baseline:
- Spherical Equivalent Refractive Error (SERE): between -0.75 and -5.00 D inclusive.
- Astigmatism: ≤ -0.75 D
- Anisometropia: < 1.000
Who cannot join
- Has previously worn or currently wears rigid or gas permeable contact lenses, including orthokeratology lenses,
- Appears to exhibit poor personal hygiene, that, in the Investigator's opinion, might prevent safe contact lens wear.
- Is currently, or within 30 days prior to this study has been, an active participant in another clinical study.
- Current or prior use of bifocals, progressive addition lenses, atropine, pirenzepine, multifocal or specialized contact lenses, or ANY other myopia control treatment.
- The Investigator for any reason considers that it is not in the best interest of the subject to participate in the study, including if the child is not mature enough to independently handle and care for soft contact lenses.
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
United States4 sites
Bellaire Family Eye Care
Bellaire, Texas, 77401
North Suburban Vision Consultants
Deerfield, Illinois, 60015
Fig Garden Optometry
Fresno, California, 93704
Cooper Eye Care
New York, New York, 10065
Canada2 sites
Toronto Eye Care
Toronto, Ontario, M4W 1A5
University of Waterloo School of Optometry
Waterloo, Ontario, N2L 3G1
About this study
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.
- Conditions
- Myopia
- Being tested
- Single vision contact lenses, Multifocal contact lenses
- Keywords
- Myopia, Refractive Error
- Medical subject headings
- Myopia, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single vision contact lensesDevice
Wearing contact lenses during waking hours may alter the progression of myopia
Multifocal contact lensesDevice
Wearing contact lenses during waking hours may alter the progression of myopia
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Contact lens with refractive correction, single vision optic Receives: Device: Single vision contact lenses |
| Treatment | Experimental | Contact lens with refractive correction, multifocal optic Receives: Device: Multifocal contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Refractive Error relative to Baseline
Mean change in cycloplegic auto-refraction (D)
Measured: Baseline, 12, 24, 36 months
Secondary outcomes (1)
Change in Axial Length
Mean change in Axial Length (mm)
Measured: Baseline,12, 24, 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start22 Jan 2022
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Visioneering Technologies, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ashley Tuan, OD, PhD, Study chair, VTI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05159765
- Sponsor's protocol ID
- VTI-NVMF-MPC-RCT-001
- Acronym
- PROTECT
- Status last verified
- Sep 2025
- First submitted
- 2 Dec 2021
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial
- ClinicalTrials.gov ID
- NCT05159765
- Acronym / sponsor ID
- PROTECT / VTI-NVMF-MPC-RCT-001
- Conditions
- Myopia
- Keywords
- Myopia, Refractive Error
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Visioneering Technologies, IncIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2022 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 16 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Device: Single vision contact lensesContact lens with refractive correction, single vision optic |
| Treatment | Experimental | Device: Multifocal contact lensesContact lens with refractive correction, multifocal optic |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Male or female, aged 7 to <13 (inclusive) at the Screening/Baseline examination.
- Meet the following refractive criteria determined by cycloplegic autorefraction at Screening/Baseline:
Key exclusion criteria (5 listed)
- Has previously worn or currently wears rigid or gas permeable contact lenses, including orthokeratology lenses,
- Appears to exhibit poor personal hygiene, that, in the Investigator's opinion, might prevent safe contact lens wear.
- Is currently, or within 30 days prior to this study has been, an active participant in another clinical study.
- Current or prior use of bifocals, progressive addition lenses, atropine, pirenzepine, multifocal or specialized contact lenses, or ANY other myopia control treatment.
- The Investigator for any reason considers that it is not in the best interest of the subject to participate in the study, including if the child is not mature enough to independently handle and care for soft contact lenses.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single vision contact lensesWearing contact lenses during waking hours may alter the progression of myopia | Device | Control |
| Multifocal contact lensesWearing contact lenses during waking hours may alter the progression of myopia | Device | Treatment |
Primary outcome
Change in Refractive Error relative to Baseline
Time frame: Baseline, 12, 24, 36 months
Mean change in cycloplegic auto-refraction (D)
1 secondary outcome
Change in Axial Length
Time frame: Baseline,12, 24, 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashley Tuan, OD, PhD study chair
VTI
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single vision contact lenses and Multifocal contact lenses in people with Myopia, run by Visioneering Technologies, Inc at 8 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Canada, Hong Kong, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Refractive Error relative to Baseline (time frame: Baseline, 12, 24, 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.