Myopia
Conditions
Brief summary
This project is a multi-center, randomized, parallel-controlled, non-inferior clinical trial of soft contact lenses.
Detailed description
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.
Interventions
DEVICEContact Lenses
Contact lenses for vision correction
Sponsors
Menicon Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed