BridgeMD
Safety and efficacy of T10430 eye drops in controlling paediatric myopia progression
EU CTIS ID: 2025-521563-13-01
What this study is testing
To evaluate the ocular safety of T10430
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Informed consent signed and dated.
- Male or female participant between ≥ 6 and < 12 years old.
- Spherical equivalent refractive error (SER) of at least -1.00D and no more than -6.00D in each eye as measured by cycloplegic autorefraction.
- IOP < 21mmHg in each eye.
- Distant BCVA equal or better than 0.1 LogMAR [≤ 0.1 LogMAR (equivalent to ≥ 20/25 Snellen)] in each eye.
You likely can't join if
- Ophthalmic exclusion criteria in AT LEAST ONE EYE (1-11): Known intolerance to administration of eye drops.
- History of non-axial cause of myopia (refractive or secondary myopia).
- History of abnormal ocular refractive anatomy (e.g., keratoconus, keratoglobus, lenticonus, spherophakia).
- Systemic/non-ophthalmic exclusion criteria (12-13): 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).
- 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.
- Specific exclusion criteria regarding sexually active individuals (14-15): Pregnancy for post-menarche participant (confirmed with a positive urine pregnancy test).
See the full eligibility criteria
Who can join
- Informed consent signed and dated.
- Male or female participant between ≥ 6 and < 12 years old.
- Spherical equivalent refractive error (SER) of at least -1.00D and no more than -6.00D in each eye as measured by cycloplegic autorefraction.
- IOP < 21mmHg in each eye.
- Distant BCVA equal or better than 0.1 LogMAR [≤ 0.1 LogMAR (equivalent to ≥ 20/25 Snellen)] in each eye.
What rules you out
- Ophthalmic exclusion criteria in AT LEAST ONE EYE (1-11): Known intolerance to administration of eye drops.
- History of non-axial cause of myopia (refractive or secondary myopia).
- History of abnormal ocular refractive anatomy (e.g., keratoconus, keratoglobus, lenticonus, spherophakia).
- Systemic/non-ophthalmic exclusion criteria (12-13): 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).
- 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.
- Specific exclusion criteria regarding sexually active individuals (14-15): Pregnancy for post-menarche participant (confirmed with a positive urine pregnancy test).
- 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): Inability of participant and/or legal guardian(s) to understand the study procedures or to give informed consent.
- 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).
- Participation in this study at the same time as another clinical study.
- 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).
- Astigmatism > 1.50D as measured by cycloplegic autorefraction.
- Participant previously randomised in this study.
- Participant being family member of the study sites or of the Laboratoires Théa company.
- 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).
- Anisometropia ≥ 1.50D as measured by cycloplegic autorefraction.
- Current or history of amblyopia or manifest strabismus including intermittent tropia.
- Current or history of glaucoma.
- Current or history of significant or severe damage to the cornea.
- Presence of anterior segment pathology (e.g. iris malformation, cataract).
- Presence of posterior segment or retinal pathology (dystrophies).
- History of any disease or syndrome that predisposed the participant to severe myopia (e.g., Marfan syndrome, Stickler syndrome, retinopathy of prematurity).
The study team makes the final eligibility decision.
Where it's taking place
- New Zealand
- South Africa
- Saudi Arabia
- United States
- Serbia
- Tunisia
- Canada
- Jordan
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Zealand; South Africa; Saudi Arabia; United States; Serbia; Tunisia and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.