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

NCT07522242 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: LT10430-2012025-521563-13-01
• Study Type: interventional
• Target: 200
• Locations: 3 countries
• Sites: 10

Brief 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.

Conditions

Myopia

Keywords

Paediatric myopia

Outcome Measures

Primary Outcomes (1)

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

  Frequency of ocular treatment-emergent adverse events (TEAEs), serious ocular TEAEs, IMP-related ocular TEAEs, ocular TEAEs leading to premature IMP discontinuation by system organ class (SOC) and preferred term (PT).

  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.

Secondary Outcomes (3)

• Effectiveness of T10430 on Axial Length Change

  From the start of treatment to 6 months and 12 months of treatment.

• Effectiveness of T10430 on Spherical Equivalent Refraction

  From the start of treatment to 6 months and 12 months of treatment.

• Assessment and collection of T10430 Safety events during Physical and Eye examinations

  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.

Study Arms (4)

T10430 lower dose

EXPERIMENTAL

The participant will be administered NaPB (lower concentration).

Drug: T10430 lower dose

T10430 middle dose

EXPERIMENTAL

The participant will be administered of NaPB (middle concentration).

Drug: T10430 middle dose

T10430 higher dose

EXPERIMENTAL

The participant will be administered of NaPB (higher concentration).

Drug: T10430 higher dose

Vehicle

PLACEBO COMPARATOR

The participant will be administered an unpreserved ophthalmic solution without active substance.

Drug: Vehicle

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 lower dose

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 middle dose

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).

T10430 higher dose

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).

Vehicle

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- 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.

You may not qualify if:

• 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).
• Known or suspected hypersensitivity to one of the components of the IMP (T10430) or diagnostic agents used during the study (e.g., fluorescein, cycloplegic agent).
• History of or active relevant systemic condition (e.g., connective tissue disease, allergy) incompatible with the study or likely to interfere with the study results or the participant safety according to investigator's judgment.
• Adolescent of childbearing potential (male/female) who is sexually active and is not willing to use preventive measures.
• Inability of participant and/or legal guardian(s) to understand the study procedures or to give informed consent.

Sponsors & Collaborators

• Laboratoires Thea: lead

Study Sites (10)

Abdali Hospital

Amman, Jordan

NOT YET RECRUITING

Istiklal Hospital

Amman, Jordan

NOT YET RECRUITING

Jordan University Hospital

Amman, Jordan

NOT YET RECRUITING

Irbid Specialty Hospital

Irbid, Jordan

NOT YET RECRUITING

Pharmaceutical research center at Jordan University of Science and Technology

Irbid, Jordan

NOT YET RECRUITING

IATROS INTERNATIONAL PTY Ltd

Brandwag, South Africa

RECRUITING

Pretoria Eye Institute Research Foundation

Pretoria, South Africa

RECRUITING

Hôpital Universitaire Tahar Sfar Mahdia

Mahdia, Tunisia

NOT YET RECRUITING

Hôpital Farhat-Hached

Sousse, Tunisia

NOT YET RECRUITING

Hôpital Charles Nicolle

Tunis, Tunisia

NOT YET RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

Corentin LE CAMUS

CONTACT

+33473981436; corentin.lecamus@theapharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Neither the participants nor the study doctors will know who is in which assigned group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study will include four treatment groups. Three groups will receive different strengths of the investigational eye-drop T10430. One group will receive a placebo, which is a salt-water solution and contains no active ingredient.It looks and is given in the same way as the study drug.

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: April 13, 2026
• Study Start: January 21, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

JO (5); ZA (2); TU (3)