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New contact lenses aim to slow nearsightedness in kids

NCT ID NCT05243836

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

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

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

About 441 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2023

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

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

8 to 14 years

Sex

Anyone

Healthy volunteers

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

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

  • Centre Universitari de la Visió

    Terrassa, Barcelona, 08222, Spain

  • LV Prasad Eye Institute

    Hyderabad, Telangana, 500034, India

  • Lab. de Superficie Ocular y Lentes de Contacto (SOYLC)

    Santiago de Compostela, Galicia, 15899, Spain

  • Ocupharm Research Group (Clinica Universitaria de Optometría), Universidad Complutense Madrid

    Madrid, Madrid, 28037, Spain

  • Shanghai Fudan University Eye and ENT Hospital

    Shanghai, Xuhui District, 200031, China

  • Tianjin Medical University

    Tianjin, Wuqing District, 300384, China

  • 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.