Progressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial (PROTECT)

Visioneering Technologies

Status: Enrolling

Conditions: Myopia

Treatments: Device: Multifocal contact lenses; Device: Single vision contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT05159765

VTI-NVMF-MPC-RCT-001

Details and patient eligibility

About

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.

Enrollment: 144 estimated patients

Sex: All

Ages: 7 to 13 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Male or female, aged 7 to <13 (inclusive) at the Screening/Baseline examination.

2. 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

1. Has previously worn or currently wears rigid or gas permeable contact lenses, including orthokeratology lenses,
2. Appears to exhibit poor personal hygiene, that, in the Investigator's opinion, might prevent safe contact lens wear.
3. Is currently, or within 30 days prior to this study has been, an active participant in another clinical study.
4. Current or prior use of bifocals, progressive addition lenses, atropine, pirenzepine, multifocal or specialized contact lenses, or ANY other myopia control treatment.
5. 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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144 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Contact lens with refractive correction, single vision optic

Treatment:

Device: Single vision contact lenses

Treatment

Experimental group

Description:

Contact lens with refractive correction, multifocal optic

Treatment:

Device: Multifocal contact lenses