Pre-myopia
Conditions
Brief summary
This study will evaluate the effect of dual focus contact lenses on Myopia prevention.
Interventions
DEVICETest Lens - Dual Focus
Dual-Focus Contact Lens
Sponsors
CooperVision International Limited (CVIL)
Shanghai Eye Disease Prevention and Treatment Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
1. Male and female children aged between 8-10 years inclusive. 2. Cycloplegic SER from -0.25 (non-inclusive) to +0.75 D (inclusive) in both eyes. 3. Astigmatism ≤ -1.00D in both eyes. 4. Un-corrected visual acuity (UCVA) ≤ 0.1 LogMAR. 5. As applicable (dependent on local requirements), the subject and parent/legal guardian will have read the Informed Assent/Consent, been given an explanation of the study, indicated an understanding and signed the forms. 6. Along with their parent or guardian, be capable of comprehending the nature of the study, and be willing and able to adhere to the instructions set forth in this protocol. 7. Along with their parent or guardian, agree to maintain the visit schedule and be able to keep all appointments as specified in the study protocol for the duration of the study. 8. Agree and able to wear the assigned contact lenses successfully for a minimum of 10 hours per day, at least 6 days per week, for the duration of the study and to inform the study investigator if this schedule is interrupted. (Wearing time may be modified by the study staff for health reasons.) 9. Be in good general health, based on his/her and parent's/guardian's knowledge. 10. Any history of myopia control interventions with in 1 month must complete a 4-weeks of washout period.
Exclusion criteria
1. History of myopia control intervention (e.g., atropine, orthokeratology, soft myopia control contact lenses, red light therapy, etc. over more than 1 month) 2. Currently wears rigid gas permeable contact lenses, including orthokeratology lenses. 3. Current use of systemic or ocular or medications which may affect contact lens wear, tear film production, pupil size, accommodation or refractive state. 4. Ocular or systemic disease that contraindicates contact lens wear. 5. Active allergic conjunctivitis. 6. Any ocular, systemic or neuro-developmental conditions that could influence refractive development. 7. Keratoconus or an irregular cornea. 8. History of clinically significant binocular vision abnormality or strabismus. 9. Any active anterior segment finding that would contraindicate contact lens wear. 10. The investigator for any reason considers that it is not in the best interest of the subject to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Myopia onset (cycloplegic SER ≤ -0.50D) in either or both eyes at 2 years. | Through study completion, 2 years. |
Countries
China
Contacts
CONTACTBaskar Arumugam Sr. Research Lead, PhD
PRINCIPAL_INVESTIGATORXiangui He, PhD
Shanghai Eye Disease Prevention and Treatment Center
PRINCIPAL_INVESTIGATORMengjun Zhu
Shanghai Eye Disease Prevention and Treatment Center
Outcome results
None listed