This was a single group, open-label clinical study to assess the safety and efficacy of Yung Sheng 38% color contact lens for vision correction.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
71
Vision Correction
The effectiveness of corrected visual acuity
The visual acuity after contact lens correction should be more than or equal to 1.0 at the final visit for each subject. The percentage of successful contact lens correction of visual acuity should be more than 90 % among all subjects.
Time frame: 3 Months
Lens fitting (Lens position)
Lens position should be "in the middle of eyes". The successful percentage among all subjects should be more than 80 %. Slit-lamp biomicroscopy will be assessed according to the approved study biomicroscopy CRF.
Time frame: Day 1, 1 week, 2 weeks, 1 month, 2 months and 3 months
Lens fitting (Lens movement)
Lens movement should be less than "1.5 mm". The successful percentage among all subjects should be more than 80 %. Slit-lamp biomicroscopy will be assessed according to the approved study biomicroscopy CRF.
Time frame: Day 1, 1 week, 2 weeks, 1 month, 2 months and 3 months
Lens fitting (Lens edge)
Lens edge should be normal after wearing. The successful percentage among all subjects should be more than 80 %. Slit-lamp biomicroscopy will be assessed according to the approved study biomicroscopy CRF.
Time frame: Day 1, 1 week, 2 weeks, 1 month, 2 months and 3 months
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