Myopia and Myopic astigmatism
Conditions
Interventions
Enrolled subjects will be randomly assigned to either the test lens group or the control lens group, and either of daily disposal lenses will be prescribed according to the assignment results. Subject
Sponsors
Misumi Nobuko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject who have read the informed assent form (IAF) for participation in the study, received an explanation of the IAF, understood the IAF, and can voluntarily consent to participate in the study. 2. The subject's legally acceptable representative has read the informed consent form (ICF), received and explanation of the ICF, understood the ICF, and can sign the ICF. 3. Subjects who understand the nature of the study and are willing to comply with the requirements, along with their legally acceptable representative. 4. Subjects who are willing to cooperate voluntarily with the study plan, such as following the follow-up schedule, along with their legally acceptable representative. 5. Subjects who can agree to be randomized. 6. Subjects who are willing to wear the study lens for 10 hours a day for at least 6 days a week during the study period. In addition, those who can agree to inform the investigator if this wearing schedule is suspended. 7. Subjects who have glasses with good vision available for use or will have glasses when they start to wear the study lenses. 8. Subjects who are generally in good health based on his/her and legally acceptable representative's knowledge. 9. Subjects who have a best-corrected visual acuity (BCVA) of +0.10 logMAR or more in each eye. 10. Subjects whose spherical equivalent power is -0.75 to -4.00D and cylindrical diopter is -0.75D or less and the difference in refractive power between right and left eyes is less than 1.00D in the cycloplegic refraction test using an autorefractometer at the initial visit.
Exclusion criteria
Exclusion criteria: 1. Subjects who appears to have poor hygiene habits. 2. Subjects who are participating or have participated in another clinical study (clinical trial) within 30 days prior to this study. 3. The subject's legally acceptable representative is an employee including investigator at the medical institution of this study. 4. Subjects who have previously worn HCL (RGP lenses), including orthokeratology lenses. 5. Subjects who are currently receiving or have previously received any myopia control treatment such as bifocal/progressive contact lenses or atropine. 6. Subjects who regularly use ocular medications, including artificial tears (prescription or over-the-counter drugs). 7. Subjects with a history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates, infectious ocular inflammation, or other recurrent ocular inflammation. 8. Subjects diagnosed with strabismus. 9. Subjects with known ocular or systemic disease, such as, but not limited to, anterior uveitis, iritis, episcleritis, scleritis, glaucoma, Sjogren's syndrome, systemic lupus erythematosus, scleroderma or diabetes mellitus. 10. Subjects with keratoconus or an irregular cornea. 11. An investigator considers that it is not in the best interest of the subject to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective refractive power (spherical equivalent) under cycloplegic conditions | — |
Secondary
| Measure | Time frame |
|---|---|
| Axial length | — |
Contacts
Public ContactNobuko Misumi
CooperVision Japan, Inc.
Outcome results
None listed