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This is a prospective, randomized, double-blind, parallel, active-controlled, multi-center clinical study. The purpose is to evaluate the safety and effectiveness wearing "MSiHy Silicone Hydrogel Soft Contact Lens".
Subjects will be randomized in 1:1 ratio to wear either the investigational device "MSiHy Silicone Hydrogel Soft Contact Lens" or the control device Monthly Silicone Hydrogel Contact Lenses(oA)".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MSiHy Silicone Hydrogel Soft Contact Lens | Experimental | New Monthly disposable contact lenses |
|
| Monthly Silicone Hydrogel Contact Lenses (oA) | Active Comparator | Monthly disposable contact lens products already on the market |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MSiHy Silicone Hydrogel Soft Contact Lens | Device | The daily wear, monthly disposable soft contact lens for the correction of myopia and hyperopia in person with non-diseased eyes. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Correction | The effectiveness of vision correction is defined by the proportion of subjects whose contact lens corrected visual acuity in both eyes is 1.0 or greater. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Correction | The effectiveness of vision correction is defined by the proportion of subjects whose contact lens corrected visual acuity in both eyes is 1.0 or greater. | 1 week, 2 week, 1 month and 2 months |
| Change in refraction |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MayKay Memorial Hospital | Taipei | 10449 | Taiwan | |||
| Tri-Service General Hospital |
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| Monthly Silicone Hydrogel Contact Lenses (oA) | Device | The daily wear, monthly disposable soft contact lens for the correction of myopia and hyperopia in person with non-diseased eyes. |
|
the sphere and cylinder power of subjective refraction
| 1 week, 2 week, 1 month, 2 months and 3 months |
| Taipei |
| 114202 |
| Taiwan |
| Chang Gung Memorial Hospital, Linkou | Taoyuan | Taiwan |
| ID | Term |
|---|---|
| D009216 | Myopia |
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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