Myopia
Conditions
Keywords
Myopia, Refractive Error
Brief 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.
Interventions
Wearing contact lenses during waking hours may alter the progression of myopia
Wearing contact lenses during waking hours may alter the progression of myopia
Sponsors
Visioneering Technologies, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
7 Years to 13 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Refractive Error relative to Baseline | Baseline, 12, 24, 36 months | Mean change in cycloplegic auto-refraction (D) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Axial Length | Baseline,12, 24, 36 months | Mean change in Axial Length (mm) |
Countries
Canada, Hong Kong, Singapore, United States
Outcome results
None listed