Mild and moderate myopia and myopic astigmatism
Conditions
Interventions
Randomly assigned to test group or control group, subjects will wear either contact lenses lens according to the randomization for two years. After two years all subjects will wear control lenses for
Sponsors
Nakamura Kikue
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Children aged 6 to 12 at the time of consent acquisition. 2) Children with cycloplegic objective refractive error (spherical equivalent) in both eyes from -0.75 to -6.00D. 3) Children with cycloplegic astigmatism no more than 1.00D. 4) Children with cycloplegic spherical equivalent difference of 1.50D or less between the left and right eyes. 5) Children with best corrected visual acuity of 1.0 or higher in each eye. 6) Children who can undergo cycloplegia. 7) Children who can attend all scheduled visits according to the clinical trial plan. 8) Children who along with their legal guardians (parents) have been signed the informed consent form to participate in this clinical trial.
Exclusion criteria
Exclusion criteria: 1) Children with visual function disorder 2) Children with amblyopia and or manifest strabismus 3) Children with corneal and conjunctiva findings 4) Children with ocular or systemic disease that can affect vision and refractive power 5) Children who are treated or have been treated for myopia with bifocal or multifocal contact lenses, orthokeratology, drugs, crocetin-containing supplements, etc. 6) Children who are judged to be inappropriate for wearing soft contact lenses 7) Children wearing or have experience wearing contact lenses 8) Children wearing contact lens monocularly 9) Children who participate in or have participated in other clinical trials, in any area within the last 3 months, or who plan to participate in a clinical trial within this trial period. 10) Childrenwho are judged to be unsuitable as subjects for this clinical trial by the principal investigator or other investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of the cycloplegic refractive (spherical equivalent) and axial length at week 104th compared to pre-examination (baseline). | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of the cycloplegic refractive (spherical equivalent) and axial length at week 26th, 52th and 78th compared to pre-examination (baseline). | — |
Contacts
Public ContactKikue Nakamura
SEED Co., Ltd.
Outcome results
None listed