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This project is an open, parallel, randomly controlled, and non-inferiority clinical trial of MSENCI soft hydrophilic contact lenses with Oxypure color soft hydrophilic contact lenses used as the control product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BenQ Materials MSENCI lenses | Experimental | BenQ Materials Daily disposable contact lens wears for 1 month |
|
| Visco Oxypure lens | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BenQ Materials MSENCI soft hydrophilic contact lenses | Device | Test lenses were to be worn for approximately 90 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| efficacy evaluation indexes | Binocular CVA with lenses after wearing lenses, 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 | Instant iris color change after wearing lenses Binocular CVA with lenses ≥ 1.0 | on the day of wearing the lens and after wearing lenses for 30 days and 90 days |
Inclusion Criteria:
Age ≥ 18 years old, no gender limitation;
Soft hydrophilic contact lenses worn should be from 0.00D to -12.00D;
Subjects should have normal binocular conditions without any abnormality or diseases except for ametropia;
The optimal binocular CVA with glasses ≥ 1.0;
The astigmatism should be ≤1.5D;
Binoculus BUT >5s;
should accept follow-ups for at least 90 days and wear the contact lens as required in the protocol;
should understand the purpose of the trial, volunteer to attend and sign the Informed Consent Form by the subjects themselves or their legal guardians.
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Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BenQ Materials Corporation | Taoyuan | 33341 | China |
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| Visco Oxypure 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 lens | 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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