Dual focus contact lenses to help prevent myopia in kids

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study enrolls children 8 to 10 years old with specific refractive criteria to see if dual focus contact lenses can reduce myopia progression. Participants wear the assigned lenses for at least 10 hours a day, six days a week, over the study duration. The trial is conducted at the Shanghai Eye Disease Prevention and Treatment Center with support from CooperVision International Limited. Informed consent from guardians and assent from children are required, and adherence to visit schedules is essential.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shanghai Eye Disease Prevention and Treatment Center
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Xiangui He, PhD — Shanghai Eye Disease Prevention and Treatment Center
• Study coordinator: Baskar Arumugam Sr. Research Lead, PhD
• Email: barumugam@coopervision.com
• Phone: 925-353-8468

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Preventing early childhood myopia with special spectacle lenses and low-dose atropine

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• Virtual Far-sight Reading Device for Pre-myopia in Children

  A device-guided reading program is tested to see if it can slow or prevent myopia in kids with pre-myopia and if it's safe with daily use for up to 6 months.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.