Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spherical Lens | Experimental | Randomized to Spherical Lens worn in a daily disposable mode |
|
| SiHy Daily | Active Comparator | Randomized to SiHy Daily worn in a daily disposable mode |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contact Lenses | Device | Contact lenses for vision correction |
|
| 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 |
| 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 |
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Li Lihua, MD | Tianjin Eye Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Eye Hospital | Tianjin | China |
Not provided
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003261 | Contact Lenses |
| ID | Term |
|---|---|
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided