Myopia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Participants enrolled in the trial must:? Be accompanied by a parent or guardian who is able to read and comprehend Mandarin and give informed consent as demonstrated by signing a record of informed consent; 1. Be experienced in wearing soft contact lenses; 2. At baseline, be within the age range of 10 to 17 years old inclusive; 3. Be of Chinese ethnicity; 4. At baseline, be myopic (short-sighted) up to -8.00 D of spherical equivalent; 5. Be willing to comply with the wearing and clinical trial visit schedule as directed by the investigator; 6. Have ocular health findings considered to be "normal" and which would not prevent the subject from safely wearing contact lenses; 7. Have distance vision correctable to at least 6/9.5 or better in each eye with study contact lenses.
Exclusion criteria
Exclusion criteria: Participants enrolled in the trial must NOT have: 1. Any pre-existing ocular irritation, injury or condition (including infection or disease) of the cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses; 2. Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto immune diseases such as ankylosing spondylitis, multiple sclerosis, Sj?grens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants; 3. Eye surgery within 12 weeks immediately prior to enrolment for this trial; 4. Previous corneal refractive surgery; 5. Keratoconus; 6. A known allergy to, or a history of intolerance to tropicamide or topical anaesthetics; 7. Had strabismus and/or amblyopia; 8. Any ocular, systemic or other condition or disease with possible associations with myopia or affecting refractive development e.g. Marfan syndrome, retinopathy of prematurity; 9. Current orthoptic treatment or vision training; 10. Undergone atropine treatment for myopia control; 11. Worn bifocal or progressive addition spectacles in the previous 12 months; 12. Worn orthokeratology lenses in the previous 12 months; 13. Require anticholinergic medication for gastrointestinal or other conditions; 14. Pregnant or lactating females (as reported by subject or their parent/guardian); 15. Currently enrolled in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cycloplegic autorefraction;Axial length; | — |
Countries
China