Clinical Trial Protocol for Safety and Efficacy of Soft Contact Lens

Clinical Trial Protocol for Safety and Efficacy of Soft Contact Lens (Model: Spherical Lens)

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.

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