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Tests treatment safety and results for Myopia
Official title Safety and Efficacy of T10430 Eye Drops in Controlling Paediatric Myopia Progression
ClinicalTrials.gov ID: NCT07522242
What this study is testing
What is T10430 lower dose?
T10430 lower dose is an investigational medicine, given as an once-daily, being studied as a potential treatment for myopia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 11
You may be able to join if
- Principal
- \- 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.
You likely can't join if
- Ophthalmic exclusion criteria in AT LEAST ONE EYE (1-11):
- Known intolerance to administration of eye drops.
- Astigmatism \> 1.50D as measured by cycloplegic autorefraction.
- Anisometropia ≥ 1.50D as measured by cycloplegic autorefraction.
- Current or history of amblyopia or manifest strabismus including intermittent tropia.
- Current or history of glaucoma.
See the full eligibility criteria
- Principal
- \- 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. Principal
- Ophthalmic exclusion criteria in AT LEAST ONE EYE (1-11):
- Known intolerance to administration of eye drops.
- Astigmatism \> 1.50D as measured by cycloplegic autorefraction.
- 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).
- 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): 12 - Known or suspected hypersensitivity to one of the...
The study team makes the final eligibility decision.
Where it's taking place
- Amman, Jordan
- Irbid, Jordan
- Brandwag, South Africa
- Pretoria, South Africa
- Mahdia, Tunisia
- Sousse, Tunisia
- Tunis, Tunisia
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, 6 years to 11 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amman, Jordan; Irbid, Jordan; Brandwag, South Africa; Pretoria, South Africa; Mahdia, Tunisia; Sousse, Tunisia and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.