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New eye drops aim to halt worsening nearsightedness in kids

NCT ID NCT07522242

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether T10430 eye drops can safely slow or stop the progression of nearsightedness (myopia) in children aged 6 to 12. Myopia often starts in childhood and can lead to serious eye problems later in life. The trial will enroll 200 children to check for side effects and measure changes in eye length and focus. The goal is to prevent severe vision issues, not to cure nearsightedness.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 200 people

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

Started

Jan 2026

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

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

6 to 11 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.

Principal Inclusion Criteria: 1. \- Informed consent signed and dated. 2. \- Male or female participant between ≥ 6 and \< 12 years old. 3. \- Spherical equivalent refractive error (SER) of at least -1.00D and no more than -6.00D in each eye as measured by cycloplegic autorefraction. 4. \- IOP \< 21mmHg in each eye. 5. \- Distant BCVA equal or better than 0.1 LogMAR \[≤ 0.1 LogMAR (equivalent to ≥ 20/25 Snellen)\] in each eye. Principal Exclusion Criteria: Ophthalmic exclusion criteria in AT LEAST ONE EYE (1-11): 1. Known intolerance to administration of eye drops. 2. Astigmatism \> 1.50D as measured by cycloplegic autorefraction. 3. Anisometropia ≥ 1.50D as measured by cycloplegic autorefraction. 4. Current or history of amblyopia or manifest strabismus including intermittent tropia. 5. Current or history of glaucoma. 6. Current or history of significant or severe damage to the cornea. 7. Presence of anterior segment pathology (e.g. iris malformation, cataract). 8. Presence of posterior segment or retinal pathology (dystrophies). 9. History of any disease or syndrome that predisposed the participant to severe myopia (e.g., Marfan syndrome, Stickler syndrome, retinopathy of prematurity). 10. History of non-axial cause of myopia (refractive or secondary myopia). 11. History of abnormal ocular refractive anatomy (e.g., keratoconus, keratoglobus, lenticonus, spherophakia). Systemic/non-ophthalmic exclusion criteria (12-13): 12 - Known or suspected hypersensitivity to one of the components of the IMP (T10430) or diagnostic agents used during the study (e.g., fluorescein, cycloplegic agent). 13- History of or active relevant systemic condition (e.g., connective tissue disease, allergy) incompatible with the study or likely to interfere with the study results or the participant safety according to investigator's judgment. 14- Specific exclusion criteria regarding sexually active individuals (14-15): Pregnancy for post-menarche participant (confirmed with a positive urine pregnancy test). 15- Adolescent of childbearing potential (male/female) who is sexually active and is not willing to use preventive measures. Exclusion criteria related to general conditions (16-21): 16- Inability of participant and/or legal guardian(s) to understand the study procedures or to give informed consent. 17- Non-compliant participant and/or legal guardian(s) (e.g., not willing to attend a visit or a phone call or to complete the diary, way of life interfering with compliance). 18- Participation in this study at the same time as another clinical study. 19- Participation in this study within the 4 weeks after the end of a previous clinical study not related to myopia (or within 5 half-lives of the previously tested product if longer than 4 weeks). 20- Participant previously randomised in this study. 21- Participant being family member of the study sites or of the Laboratoires Théa company. 22- Exclusion criteria related to previous and concomitant treatments (medications/non-medicinal therapies/procedures): Participant with previous, current or anticipated prohibited listed treatment (or prohibited modification of treatment regimen).

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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.

  1. The places running it

    10 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Abdali Hospital

    NOT_YET_RECRUITING

    Amman, Jordan

  • Hôpital Charles Nicolle

    NOT_YET_RECRUITING

    Tunis, Tunisia

  • Hôpital Farhat-Hached

    NOT_YET_RECRUITING

    Sousse, Tunisia

  • Hôpital Universitaire Tahar Sfar Mahdia

    NOT_YET_RECRUITING

    Mahdia, Tunisia

  • IATROS INTERNATIONAL PTY Ltd

    RECRUITING

    Brandwag, South Africa

  • Irbid Specialty Hospital

    NOT_YET_RECRUITING

    Irbid, Jordan

  • Istiklal Hospital

    NOT_YET_RECRUITING

    Amman, Jordan

  • Jordan University Hospital

    NOT_YET_RECRUITING

    Amman, Jordan

  • Pharmaceutical research center at Jordan University of Science and Technology

    NOT_YET_RECRUITING

    Irbid, Jordan

  • Pretoria Eye Institute Research Foundation

    RECRUITING

    Pretoria, South Africa

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