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This project is an open, parallel, randomly controlled, and non-inferiority clinical trial of DSFNC1 soft hydrophilic contact lenses with SiHy color soft hydrophilic contact lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BenQ Materials DSFNC1 lenses | Experimental | BenQ Materials contact lens wears for daily disposable |
|
| Visco SiHy Color lens | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BenQ Materials DSFNC1 soft hydrophilic contact lenses | Device | Test lenses were to be worn for approximately 90 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy evaluation indexes | The proportion of contact lens-corrected eyesight, The percentage of changes in iris color | after wearing lenses for 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time of Break up time (BUT) | Comparison of BUT time results between the experimental group and control group | on the day of wearing the lens and wearing lenses for 7 days,30 days and 90 days |
| Distance Uncorrected visual acuity (UCVA) |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy evaluation indexes | The percentage of iris color change after wearing lenses ,The proportion of contact lens corrected eyesight | on the day of wearing the lens and after wearing lenses for 30 days and 90 days |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BenQ Materials Corporation | Taoyuan | 33341 | China |
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| Visco SiHy Color soft hydrophilic contact lenses | Device | Control lenses were to be worn for approximately 90 days |
|
Comparison of distance uncorrected visual acuity results between the experimental group and control group
| on the day of wearing the lens and wearing lenses for 7 days,30 days and 90 days |
| Fitness of the contact | the position of lens on the ocular surface, the coverage, tightness and movability of len | on the day of wearing the lens and wearing lenses for 7 days,30 days and 90 days |
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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