Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a prospective, randomized, double-blind, parallel, active-controlled, multi-center clinical study. The purpose is to evaluate the safety and effectiveness wearing "DSiHy Silicone Hydrogel Soft Contact Lens". Subjects will be randomized in 1:1 ratio to wear either the investigational device "DSiHy Silicone Hydrogel Soft Contact Lens" or the control device Daily Silicone Hydrogel Contact Lenses(oB)".
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DSiHy Silicone Hydrogel Soft Contact Lens | Experimental | New Daily disposable contact lenses |
|
| Daily Silicone Hydrogel Contact Lenses (oB) | Active Comparator | Daily disposable contact lens products already on the market |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DSiHy Silicone Hydrogel Soft Contact Lens | Device | The daily wear, daily 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tri-Service General Hospital | Taipei | 114202 | Taiwan | |||
| Chang Gung Memorial Hospital, Taipei |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Daily Silicone Hydrogel Contact Lenses (oB) | Device | The daily wear, daily 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 |
| Taiwan |
| Chang Gung Memorial Hospital, Linkou | Taoyuan | Taiwan |
| ID | Term |
|---|---|
| D009216 | Myopia |
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
Not provided
Not provided