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The objective of this study is to evaluate a new daily disposable silicone hydrogel soft contact lens by comparing to an existing daily disposable soft contact lens.
This study is designed to evaluate the performance of the olifilcon B contact lens to demonstrate substantial equivalence to the narafilcon A for regulatory requirement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Si-Hy soft contact lens | Experimental | olifilon B daily disposable soft contact lens |
|
| Vistakon soft contact lens | Active Comparator | narafilcon A daily disposable soft contact lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Si-Hy (olifilcon B) | Device | Wear Si-Hy silicone hydrgel soft contact lens for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | logMAR visual acuity (VA) over all visits. | over all follow-up visits for 3 month study period |
| Measure | Description | Time Frame |
|---|---|---|
| Any Slit Lamp Finding > Grade 2 | All dispensed eyes over all follow-up visits. Measured on a scale of 0-4 with 0=no findings and 4=sever findings. | over all follow-up visits for the 3 month study period |
| Subjective Response to Comfort, symptoms and complaints |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huey Chuan Cheng, MD MS | Mackay Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MayKay Memorial Hospital | Taipei | Taiwan |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Vistakon (narafilcon A) | Device | Wear Vistakon soft contact lens for 3 months |
|
subjective ratings of comfort, symptom and complaints using a scale of 0=severe stinging/Burning to 10=No stinging/Burning for each eye; 0 represented the least favorable rating and a 100 represented the most favorable rating. |
| over all follow-up visits for the 3 month study period |