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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | Contact lens with refractive correction, single vision optic |
|
| Treatment | Experimental | Contact lens with refractive correction, multifocal optic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single vision contact lenses | Device | Wearing contact lenses during waking hours may alter the progression of myopia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Refractive Error relative to Baseline | Mean change in cycloplegic auto-refraction (D) | Baseline, 12, 24, 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Axial Length | Mean change in Axial Length (mm) | Baseline,12, 24, 36 months |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Ashley Tuan, OD, PhD | VTI | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fig Garden Optometry | Fresno | California | 93704 | United States | ||
| North Suburban Vision Consultants |
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| Multifocal contact lenses | Device | Wearing contact lenses during waking hours may alter the progression of myopia |
|
| Deerfield |
| Illinois |
| 60015 |
| United States |
| Cooper Eye Care | New York | New York | 10065 | United States |
| Bellaire Family Eye Care | Bellaire | Texas | 77401 | United States |
| Toronto Eye Care | Toronto | Ontario | M4W 1A5 | Canada |
| University of Waterloo School of Optometry | Waterloo | Ontario | N2L 3G1 | Canada |
| Hong Kong Polytechnic University | Tsim Sha Tsui | Hong Kong |
| Myopia Specialist Centre | Singapore | Singapore |
| ID | Term |
|---|---|
| D009216 | Myopia |
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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