Clinical Trial Protocol for Safety and Efficacy of Soft Contact Lens

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.

• Contact Lenses (Device): Contact lenses for vision correction

Primary outcomes

• The ratio of corrected visual acuity of left and right eyes is ≥5.0 [1 week]: 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.
• The occurrence of adverse events [3 month]: 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.

Secondary outcomes

• BCVA (spectacles) and BCVA (CL) [1 week, 1 month, 3 months]: BCVA (spectacles and CL) of both eyes are compared at baseline and at each follow-up.

Sex: All, ages: 18 Years to 45 Years, accepts healthy volunteers

Inclusion Criteria:

* Male or female with age of 18 to 45
* Spherical power: -0.25 to -10.00D
* Cylinder power ≤0.75D and Sph.P:Cyl.P≥3:1, or 1.00D≤ cylinder power ≤1.50D and Sph.P:Cyl.P ≥4:1;
* Both eyes are ametropia, and there is no case where the investigator believes that the soft contact lens cannot be worn;

  : The case of wearing a soft contact lens as referred to in this trial is: i) No eyelid abnormalities or infections; ii) No clinically significant slit lamp findings iii) No other active eye diseases.
* BCVA of the left and right eye subjective refraction is greater than or equal to 5.0.

Exclusion Criteria:

* Need to use therapeutic ophthalmic drugs, including antibiotics, hormones and compound ophthalmic drugs containing hormones
* Dry eye syndrome
* Any systemic disease contraindications to contact lenses or disease medications can affect the wearing of contact lenses
* Wearing a hard contact lens in the past 6 weeks
* Tear film break-up time is less than or equal to 5s
* Allergic to contact lenses and/or contact lenses
* Keratoconus or other irregular corneal patients
* Soft hydrophilic contact lens wearers are affected by long-term special conditions such as dryness, severe dust or volatile chemicals
* Pregnant, lactating or plan to be pregnant
* Only one eye meets the requirements for enrollment
* Participating in other clinical trials or less than ten days after the end of a soft contact lens clinical trial
* Less than three months after the end of a drug clinical trial
* Determined by the investigator that could not be enrolled

• Li Lihua, MD, Principal investigator, Tianjin Eye Hospital