A Phase 2 interventional study of T10430 lower dose and T10430 middle dose in Myopia, sponsored by Laboratoires Thea. Recruiting at 10 sites in 3 countries. Open to participants aged 6 Years to 11 Years. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Laboratoires Thea · Phase 2, Interventional, and Prevention
Axial myopia is a type of nearsightedness that happens when the eye is too long from front to back. This causes distant vision to be blurry. Axial myopia tends to start during childhood and worsens over time (as the eyes continue to grow longer). This can lead to serious eye-related conditions later in life. The aim of T10430 treatment is to stop or slow this progression during childhood and therefore, prevent more serious complications. Animal studies using drugs with a similar mechanism of action as T10430 have demonstrated positive safety results. This study aims to better understand the safety and potential effectiveness of T10430 in children with axial myopia.
The study drug, T10430, is an eye drop solution. Participants in the study will receive one of three different strengths of the T10430 eye drops or a placebo. The study will include 200 participants, aged 6 to 11 years, who have a specific type of nearsightedness.
1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.
This study's planned enrollment of 200 is above the median of 78 across 923 interventional studies indexed under Myopia.
Browse Myopia studies →Laboratoires Thea is the lead sponsor of 64 studies on the registry; 6 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Principal Inclusion Criteria:
Principal Exclusion Criteria:
Ophthalmic exclusion criteria in AT LEAST ONE EYE (1-11):
Systemic/non-ophthalmic exclusion criteria (12-13):
12 - Known or suspected 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 (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).
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The participant will be administered NaPB (lower concentration).
Drug: T10430 lower dose
The participant will be administered of NaPB (middle concentration).
Drug: T10430 middle dose
The participant will be administered of NaPB (higher concentration).
Drug: T10430 higher dose
The participant will be administered an unpreserved ophthalmic solution without active substance.
Drug: Vehicle
The participant will be instilled 1 drop of the T10430 in the conjunctival cul-de-sac of each eye, once daily, at 20h00 (±2 hours) from Day 1 to the day before the End of treatment visit (Visit #4).
The participant will be instilled 1 drop of the T10430 in the conjunctival cul-de-sac of each eye, once daily, at 20h00 (±2 hours) from Day 1 to the day before the End of treatment visit (Visit #4).
The participant will be instilled 1 drop of the T10430 in the conjunctival cul-de-sac of each eye, once daily, at 20h00 (±2 hours) from Day 1 to the day before the End of treatment visit (Visit #4).
The participant will be instilled 1 drop of the vehicle in the conjunctival cul-de-sac of each eye, once daily, at 20h00 (±2 hours) from Day 1 to the day before the End of treatment visit (Visit #4).
Measure of the occurrence of treatment-emergent adverse events (TEAEs).
Frequency of ocular treatment-emergent adverse events (TEAEs), serious ocular TEAEs, IMP-related ocular TEAEs, ocular TEAEs leading to premature IMP discontinuation by system organ class (SOC) and preferred term (PT).
Time frame: From the time the participant signs the assent and their legual guardian the informed consent and throughout the entire study: up to approximately 60 weeks, including a maximum treatment period of 56 weeks and a 4 weeks follow-up period.
Effectiveness of T10430 on Axial Length Change
Measurement of axial length changes in mm of the eyes (from the front \[cornea\] to the back \[the retina\]).
Time frame: From the start of treatment to 6 months and 12 months of treatment.
Effectiveness of T10430 on Spherical Equivalent Refraction
Measurement of change in the focusing power of the eye, called spherical equivalent refraction, in D (Diopter).
Time frame: From the start of treatment to 6 months and 12 months of treatment.
Assessment and collection of T10430 Safety events during Physical and Eye examinations
Study doctors will record and assess any health events experienced by participants during physical and eye examinations.
Time frame: From the time the participant signs the assent and their legual guardian the informed consent and throughout the entire study: up to approximately 60 weeks, including a maximum treatment period of 56 weeks and a 4 weeks follow-up period.
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for Nov 2027, 22 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.