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This was a single group, open-label clinical study to assess the safety and efficacy of Yung Sheng 38% color contact lens for vision correction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yung Sheng 38% color contact lens | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Soft Contact Lens | Device | Vision Correction |
|
| Measure | Description | Time Frame |
|---|---|---|
| The effectiveness of corrected visual acuity | The visual acuity after contact lens correction should be more than or equal to 1.0 at the final visit for each subject. The percentage of successful contact lens correction of visual acuity should be more than 90 % among all subjects. | 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Lens fitting (Lens position) | Lens position should be "in the middle of eyes". The successful percentage among all subjects should be more than 80 %. Slit-lamp biomicroscopy will be assessed according to the approved study biomicroscopy CRF. | Day 1, 1 week, 2 weeks, 1 month, 2 months and 3 months |
| Lens fitting (Lens movement) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety evaluation |
The safety endpoint in this evaluation is the rate of serious adverse reactions related to visual acuity loss as well as accompanying slit-lamp findings and other associated observations. [Time Frame: 12 weeks] | 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yi-Yu Tsai, PhD | China Medical University Hospital | Principal Investigator |
| Mei-Ling Peng, PhD | Chung Shan Medical University | Principal Investigator |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D003263 | Contact Lenses, Hydrophilic |
| ID | Term |
|---|---|
| D003261 | Contact Lenses |
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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Lens movement should be less than "1.5 mm". The successful percentage among all subjects should be more than 80 %. Slit-lamp biomicroscopy will be assessed according to the approved study biomicroscopy CRF. |
| Day 1, 1 week, 2 weeks, 1 month, 2 months and 3 months |
| Lens fitting (Lens edge) | Lens edge should be normal after wearing. The successful percentage among all subjects should be more than 80 %. Slit-lamp biomicroscopy will be assessed according to the approved study biomicroscopy CRF. | Day 1, 1 week, 2 weeks, 1 month, 2 months and 3 months |