Safety and Efficacy of T10430 Eye Drops in Controlling Paediatric Myopia Progression

Sponsor
Laboratoires Thea
Study ID
NCT07522242
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Myopia

Eligibility Criteria

Sex
ALL
Age
6 Years - 11 Years
Healthy Volunteers
Not accepted

Interventions

  • T10430 lower dose — DRUG
    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).
  • T10430 middle dose — DRUG
    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).
  • T10430 higher dose — DRUG
    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).
  • Vehicle — DRUG
    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).

Study Details

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.

Key Dates

First listed
Apr 13, 2026
Start date
Jan 21, 2026
Status verified
Apr 2026
Primary completion
Nov 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: T10430 lower dose
    The participant will be administered NaPB (lower concentration).
  • Experimental: T10430 middle dose
    The participant will be administered of NaPB (middle concentration).
  • Experimental: T10430 higher dose
    The participant will be administered of NaPB (higher concentration).
  • Placebo Comparator: Vehicle
    The participant will be administered an unpreserved ophthalmic solution without active substance.

Primary Outcome Measure

Measure of the occurrence of treatment-emergent adverse events (TEAEs). [ 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. ]

Central Contacts

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