Progressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial

Study Overview
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Brief Summary
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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.

Official Title
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Progressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial

Conditions
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Myopia

Intervention / Treatment
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* Device: Single vision contact lenses
* Device: Multifocal contact lenses


Participation Criteria
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Eligibility Criteria
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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: 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.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Contact lens with refractive correction, single vision optic | Device: Single vision contact lenses<br>* Wearing contact lenses during waking hours may alter the progression of myopia<br>|
| Experimental: Treatment<br>Contact lens with refractive correction, multifocal optic | Device: Multifocal contact lenses<br>* Wearing contact lenses during waking hours may alter the progression of myopia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Refractive Error relative to Baseline | Mean change in cycloplegic auto-refraction (D) | Baseline, 12, 24, 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Axial Length | Mean change in Axial Length (mm) | Baseline,12, 24, 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myopia, Refractive Error