New eye drops aim to halt worsening nearsightedness in kids
NCT ID NCT07522242
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Nov 2027
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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6 to 11 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.
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.
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The places running it
10 sites in 3 countries. 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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Abdali Hospital
NOT_YET_RECRUITINGAmman, Jordan
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Hôpital Charles Nicolle
NOT_YET_RECRUITINGTunis, Tunisia
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Hôpital Farhat-Hached
NOT_YET_RECRUITINGSousse, Tunisia
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Hôpital Universitaire Tahar Sfar Mahdia
NOT_YET_RECRUITINGMahdia, Tunisia
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IATROS INTERNATIONAL PTY Ltd
RECRUITINGBrandwag, South Africa
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Irbid Specialty Hospital
NOT_YET_RECRUITINGIrbid, Jordan
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Istiklal Hospital
NOT_YET_RECRUITINGAmman, Jordan
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Jordan University Hospital
NOT_YET_RECRUITINGAmman, Jordan
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Pharmaceutical research center at Jordan University of Science and Technology
NOT_YET_RECRUITINGIrbid, Jordan
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Pretoria Eye Institute Research Foundation
RECRUITINGPretoria, South Africa
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Myopia glasses may keep working even after kids take them off