New contact lenses aim to stop kids from becoming nearsighted
NCT ID NCT07566234
First seen Jun 25, 2026 · Last updated Jul 17, 2026 · Updated 3 times
Summary
This study tests whether dual focus contact lenses can prevent myopia (nearsightedness) in children aged 8 to 10 who are at risk. Over 2 years, researchers will check if these lenses stop the onset of myopia compared to standard lenses. If it works, it could offer a simple way to protect children's vision.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Dual-Focus Contact Lens
- What this could lead to
- If successful, these lenses could offer a simple way to prevent children from becoming nearsighted, reducing the need for glasses or stronger prescriptions later.
- What could go wrong
- This is a small, early-stage study with only 110 children, so results may not apply to everyone. The lenses might not prevent myopia as hoped, and there could be discomfort or eye health risks from wearing contact lenses at a young age.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 110 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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8 to 10 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Shanghai Eye Disease Prevention and Treatment Center
RECRUITINGShanghai, 200030, China
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