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This was a prospective, randomized, open label, parallel, active-controlled clinical study to assess the safety and efficacy of Silicone Color Contact Lens for vision correction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Si-Hy (Otufilcon A) | Experimental |
| |
| Si-Hy soft contact lens | Active Comparator |
|
| 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 primary effectiveness endpoint of the study was the comparison of the mean change in logMAR visual acuity (VA) of the subject's worse eye, from baseline (Day 1) to the final visit (3-month), between the groups wearing test lenses and control lenses. | 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of corrected visual acuity | The secondary effectiveness endpoint involves comparing the mean difference in LogMAR visual acuity (VA) for each eye-both eyes of each subject-between the test lens and the control lens at one week. | 1 Week |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | Taiwan | ||||
| Tri-Service General Hospital |
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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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| Taipei |
| Taiwan |
| Linkou-Chang Gung Memorial Hospital | Taoyuan | Taiwan |