RecruitingPhase 2NCT07522242

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


Sponsor

Laboratoires Thea

Enrollment

200 participants

Start Date

Jan 21, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 6 YearsMax Age: 11 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called T10430 higher dose, a drug called T10430 lower dose, and others for people with myopia. The study is currently recruiting participants at 10 locations. People eligible for this study include aged 6 Years to 11 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGT10430 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).

DRUGT10430 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).

DRUGT10430 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).

DRUGVehicle

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).


Locations(10)

Abdali Hospital

Amman, Jordan

Istiklal Hospital

Amman, Jordan

Jordan University Hospital

Amman, Jordan

Irbid Specialty Hospital

Irbid, Jordan

Pharmaceutical research center at Jordan University of Science and Technology

Irbid, Jordan

IATROS INTERNATIONAL PTY Ltd

Brandwag, South Africa

Pretoria Eye Institute Research Foundation

Pretoria, South Africa

Hôpital Universitaire Tahar Sfar Mahdia

Mahdia, Tunisia

Hôpital Farhat-Hached

Sousse, Tunisia

Hôpital Charles Nicolle

Tunis, Tunisia

View Full Details on ClinicalTrials.gov

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NCT07522242


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