This is a prospective, randomized, double-blind, parallel, active-controlled, multi-center clinical study. The purpose is to evaluate the safety and effectiveness wearing "MSiHy Silicone Hydrogel Soft Contact Lens". Subjects will be randomized in 1:1 ratio to wear either the investigational device "MSiHy Silicone Hydrogel Soft Contact Lens" or the control device Monthly Silicone Hydrogel Contact Lenses(oA)".
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
134
The daily wear, monthly disposable soft contact lens for the correction of myopia and hyperopia in person with non-diseased eyes.
The daily wear, monthly disposable soft contact lens for the correction of myopia and hyperopia in person with non-diseased eyes.
MayKay Memorial Hospital
Taipei, Taiwan
Tri-Service General Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan, Taiwan
Visual Correction
The effectiveness of vision correction is defined by the proportion of subjects whose contact lens corrected visual acuity in both eyes is 1.0 or greater.
Time frame: 3 months
Visual Correction
The effectiveness of vision correction is defined by the proportion of subjects whose contact lens corrected visual acuity in both eyes is 1.0 or greater.
Time frame: 1 week, 2 week, 1 month and 2 months
Change in refraction
the sphere and cylinder power of subjective refraction
Time frame: 1 week, 2 week, 1 month, 2 months and 3 months
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