New contact lenses aim to slow nearsightedness in kids
NCT ID NCT05243836
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two types of contact lenses for slowing myopia (nearsightedness) in children aged 8 to 14. Over three years, researchers will measure changes in eye length and vision to see if the new lens works as well as the existing one. The goal is to help kids maintain better eyesight as they grow.
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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 441 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2023
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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A research network
The lead sponsor is a research network or cooperative group.
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 14 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: * Be between 8-14. * Have: * Read the Informed Assent. * Been explained the Informed Assent. * Indicated an understanding of the Informed Assent. * Signed the Informed Assent. * Have their parent / legal guardian: * Read the Informed Consent. * Been explained the Informed Consent. * Indicated an understanding of the Informed Consent. * Signed the Informed Consent. * Along with their parent / legal guardian, be capable of comprehending the nature of the study, and be willing and able to adhere to study requirements. * Along with their parent / legal guardian, agree to maintain the visit schedule . * Agree to wear allocated contact lenses for a minimum of 5 days per week, at least 6 hours per day on days lenses are worn but not \> 16 hours per day, and to remove lenses at night (i.e., daily wear only with no contact lens wear during sleep), for their duration of the study and to inform the investigator if their schedule is interrupted. Wearing time can be modified by the investigator for health reasons. * Possess wearable and visually functioning spectacles. * Be in good general health, based on the parent's / legal guardian's knowledge. * Have best-corrected high contrast visual acuity based on manifest refraction of 0.10 logMAR (20/25, 6/7.6) or better in each eye. * Meet the following criteria determined by cycloplegic autorefraction: * Spherical equivalent between -0.75 to -4.00 D inclusive. * Astigmatism ≥ -1.00 D. \*participants who fail astigmatism criterion with autorefraction pass astigmatism criterion if ≥ -0.75 D is measured with subjective refraction. * anisometropia ≤ 1.00 D. Exclusion Criteria: * Participant is currently, or within 30 days prior to this study, has been an active participant in another study. * Current or prior use of ANY form of myopia control, including but not limited to: * Optical devices. * Bifocal / multifocal spectacles of any type. * Bifocal / multifocal contact lenses of any type. * Orthokeratology of any type. * Pharmacological agents. * European and Indian sites: Atropine. * Chinese sites: Atropine with a concentration \> 0.01%. Participants who have previously used 0.01% atropine are eligible for this study provided they agree not to use 0.01% atropine for at least 30 days before baseline and at any time during the study. * Pirenzepine. * Participant born earlier than 30 weeks or weighed \< 1500 g at birth. * Habitual use of a systemic or topical medication that may alter normal ocular findings / is known to affect a participant's ocular health / physiology or contact lens performance either in an adverse or beneficial manner at enrolment and / or during the clinical trial. * A known allergy to sodium fluorescein, benoxinate, proparacaine, or tropicamide. * Chinese sites: A known allergy to cyclopentolate. * A known corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates, ocular viral or fungal infections, or any other recurrent ocular infections. * Strabismus by cover test at distance (3 m) or near (40 cm) while wearing distance correction under non-cycloplegic conditions. * Known ocular or systemic disease, such as but not limited to: * Diabetes. * Graves' disease. * Glaucoma. * Uveitis. * Scleritis. * Auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjogrens syndrome, and systemic lupus erythematosus. * Any ocular, systemic, or neuro-developmental conditions that could influence refractive development, such as but not limited to: * Persistent pupillary membrane. * Vitreous haemorrhage. * Cataract. * Central corneal scarring. * Eyelid haemangiomas. * Marfan's syndrome. * Down's syndrome. * Ehler's-Danlos syndrome. * Stickler's syndrome. * Ocular albinism. * Retinopathy of prematurity. * Keratoconus or irregular cornea. * Biomicroscopic that contraindicate contact lens, such as but limited to: * Neovascularisation or ghost vessels ≥ 1.5 mm in from limbus. * Any active anterior segment disease that contraindicates safe contact lens wear. * Clinically significant giant papillary conjunctivitis. * Clinically significant abnormalities of the anterior segment, lids, conjunctiva, sclera, or associated structures. * Allergic or seasonal conjunctivitis if the investigator believes it could significantly interfere with maintaining a specified wearing schedule. * The investigator may, at their discretion, exclude anyone who they believe may not be able to fulfil the clinical trial requirements or it is believed to be in the participant's best interests.
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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.
Contacts and locations
Locations
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Centre Universitari de la Visió
Terrassa, Barcelona, 08222, Spain
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LV Prasad Eye Institute
Hyderabad, Telangana, 500034, India
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Lab. de Superficie Ocular y Lentes de Contacto (SOYLC)
Santiago de Compostela, Galicia, 15899, Spain
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Ocupharm Research Group (Clinica Universitaria de Optometría), Universidad Complutense Madrid
Madrid, Madrid, 28037, Spain
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Shanghai Fudan University Eye and ENT Hospital
Shanghai, Xuhui District, 200031, China
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Tianjin Medical University
Tianjin, Wuqing District, 300384, China
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Wenzhou Medical University Eye Hospital
Wenzhou, Lucheng District, 325027, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Two lens designs go Head-to-Head for aging eyes
- Can AI protect Kids' eyesight where eye doctors are scarce?
- Two toric lenses go head to head in vision test
- Eye scans as a window to the body: study probes retinal imaging across diseases
- Lens showdown: which contact lens wins in dim light?
- Myopia glasses may keep working even after kids take them off