Active — Not RecruitingNot Applicable

Progressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial

United States, Canada144 participantsStarted 2022-01-22

Plain-language 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 total of three years.

Who can participate

Age range7 Years – 13 Years

SexALL

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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:

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.

What they're measuring

Change in Refractive Error relative to Baseline

Timeframe: Baseline, 12, 24, 36 months

Trial details

NCT IDNCT05159765

SponsorVisioneering Technologies, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-02

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