Safety and Efficacy of T10430 Eye Drops in Controlling Paediatric Myopia Progression
ConditionMyopia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age6-11
SponsorLaboratoires Thea
About this trial
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.
Eligibility criteria
Qualifiers
- 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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- T10430 lower dose
- T10430 middle dose
- T10430 higher dose
- Vehicle
Treatment groups
200 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov