Myopia
Conditions
Interventions
Test and Control:CLariti and Aquamax contact lenses
Sponsors
Brien Holden Vision Institute
Eligibility
Sex/Gender
Male
Age
8 Years to 12 Years
Inclusion criteria
Inclusion criteria: Subjects enrolled in the trial must: 1. 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; 2. at baseline, be within the age range of 8 to 12 years old inclusive; 3. be of Chinese ethnicity; 4. at baseline, be myopic (short-sighted), -0.75D to -3.50D of cycloplegic spherical equivalent with astigmatism no more than 0.75D; 5. preferably progressive myopia (based on change in spectacles or other mode of correction in the past 2 years); 6. be willing to comply with the wearing and clinical trial visit schedule as directed by the investigator; 7. have ocular health findings considered to be normal and which would not prevent the subject from safely wearing contact lenses; have vision correctable to at least 6/9.5 or better in each eye with study contact lenses.
Exclusion criteria
Exclusion criteria: Subjects enrolled in the trial must NOT have: 1. pre-existing ocular irritation that would preclude contact lens fitting; 2. any systemic or ocular condition or ocular injury that may preclude safe wearing of contact lenses; 3. undergone corneal refractive surgery; 4. Keratoconus 5. a known allergy to, or a history of intolerance to tropicamide or topical anaesthetics; 6. at baseline, astigmatism more than 0.75 D in either eye; 7. had strabismus and/or current ongoing 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. eye injury or surgery within 12 weeks immediately prior to enrolment for this trial; 11. undergone atropine treatment for myopia control; 12. worn bifocal or progressive addition spectacles or anti-myopia contact lenses previously; 13. worn orthokeratology lenses previously; 14. require anticholinergic medication for gastrointestinal or other conditions; 15. at baseline, be anisometropic by more than 1.50D; 16. current enrolment in another clinical trial/research project. The Investigator may, at his/her discretion, exclude anyone else who they believe may not be able to fulfil the study requirements (this may include the use or need of any ocular medication prior to or during the course of the trial, or any systemic medications prior to and needed during the trial that will affect ocular physiology or the performance of the lenses), or if it is believed to be in the subjects best interests.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Myopia progression; | — |
Contacts
Public ContactDr Xiang Chen
Outcome results
None listed