This project is a multi-center, randomized, parallel-controlled, non-inferior clinical trial of soft contact lenses.
The test product is the Soft Contact Lens (model: Spherical Lens), and the control product is a commercially available soft contact lens (model: SiHy Daily). The number of enrolled subjects is 148, and clinical observation is performed for 3 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
148
Contact lenses for vision correction
Tianjin Eye Hospital
Tianjin, China
The ratio of corrected visual acuity of left and right eyes is ≥5.0
The standard logarithmic visual acuity chart consistent with the guiding principle is adopted in this scheme. \- Success criteria: If the lower limit of 95% CI of the evaluated rate of corrected for visual acuity for both eyes ≥ 5.0 at 1 week visit is ≥-10%, the primary endpoint of the two groups is non-inferior.
Time frame: 1 week
The occurrence of adverse events
Compare the number of adverse events and serious adverse events, the number of cases and the incidence rate; list the number and cases of adverse events; describe the adverse events that are related to the investigational products.
Time frame: 3 month
BCVA (spectacles) and BCVA (CL)
BCVA (spectacles and CL) of both eyes are compared at baseline and at each follow-up.
Time frame: 1 week, 1 month, 3 months
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