NCT07522242

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Laboratoires Thea · Industry
• Sex: All
• Age: 6 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Myopia

Interventions

Type	Name	Description
DRUG	T10430 lower dose	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).
DRUG	T10430 middle dose	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).
DRUG	T10430 higher dose	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).
DRUG	Vehicle	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).

Timeline

• Start date: 2026-01-21
• Primary completion: 2027-11-01
• Completion: 2027-11-01
• First posted: 2026-04-13
• Last updated: 2026-04-13

Locations

10 sites across 3 countries: Jordan, South Africa, Tunisia

Regulatory

• FDA-regulated drug study