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Active, Not Recruiting

NCT Number: NCT05159765

Progressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

7 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto Eye Care, Toronto, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Single vision contact lenses

Device

Wearing contact lenses during waking hours may alter the progression of myopia

Multifocal contact lenses

Device

Wearing contact lenses during waking hours may alter the progression of myopia

Primary outcomes

  1. Change in Refractive Error relative to Baseline

    Time frame: Baseline, 12, 24, 36 months

    Mean change in cycloplegic auto-refraction (D)

Secondary outcomes

  1. Change in Axial Length

    Time frame: Baseline,12, 24, 36 months

    Mean change in Axial Length (mm)

Sponsors and collaborators

Lead sponsor

Visioneering Technologies, Inc

Industry

Registry information

Acronym: PROTECT

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Dec 16, 2021
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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