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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
192
Test lenses were to be worn for approximately 90 days.
Control lenses were to be worn for approximately 90 days
BenQ Materials Corporation
Taoyuan, China
efficacy evaluation indexes
Binocular CVA with lenses after wearing lenses, The percentage of changes in iris color
Time frame: after wearing lenses for 7 days
Time of Break up time (BUT)
Comparison of BUT time results between the experimental group and control group
Time frame: on the day of wearing the lens and wearing lenses for 7 days,30 days and 90 days
Distance Uncorrected visual acuity (UCVA)
Comparison of distance uncorrected visual acuity results between the experimental group and control group
Time frame: 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
Time frame: on the day of wearing the lens and wearing lenses for 7 days,30 days and 90 days
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