Clinical Trial Protocol for Safety and Efficacy of Soft Contact Lens

Study Overview
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Brief Summary
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This project is a multi-center, randomized, parallel-controlled, non-inferior clinical trial of soft contact lenses.

Detailed Description
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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.

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

Conditions
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Myopia

Intervention / Treatment
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* Device: Contact Lenses


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spherical Lens<br>Randomized to Spherical Lens worn in a daily disposable mode | Device: Contact Lenses<br>* Contact lenses for vision correction<br>|
| Active Comparator: SiHy Daily<br>Randomized to SiHy Daily worn in a daily disposable mode | Device: Contact Lenses<br>* Contact lenses for vision correction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BCVA (spectacles) and BCVA (CL) | BCVA (spectacles and CL) of both eyes are compared at baseline and at each follow-up. | 1 week, 1 month, 3 months |