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

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.

Study Overview

• Status: Recruiting
• Conditions: Myopia
• Intervention / Treatment: Drug: T10430 lower dose; Drug: T10430 middle dose; Drug: T10430 higher dose; Drug: Vehicle

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Corentin LE CAMUS; Phone Number: +33473981436; Email: Corentin.LECAMUS@theapharma.com

Study Locations

• Jordan
  • Amman, Jordan
    • Not yet recruiting
    • Abdali Hospital
  • Amman, Jordan
    • Not yet recruiting
    • Istiklal Hospital
  • Amman, Jordan
    • Not yet recruiting
    • Jordan University Hospital
  • Irbid, Jordan
    • Not yet recruiting
    • Irbid Specialty Hospital
  • Irbid, Jordan
    • Not yet recruiting
    • Pharmaceutical research center at Jordan University of Science and Technology
• South Africa
  • Brandwag, South Africa
    • Recruiting
    • IATROS INTERNATIONAL PTY Ltd
  • Pretoria, South Africa
    • Recruiting
    • Pretoria Eye Institute Research Foundation
• Tunisia
  • Mahdia, Tunisia
    • Not yet recruiting
    • Hôpital Universitaire Tahar Sfar Mahdia
  • Sousse, Tunisia
    • Not yet recruiting
    • Hôpital Farhat-Hached
  • Tunis, Tunisia
    • Not yet recruiting
    • Hopital Charles Nicolle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Principal Inclusion Criteria:

1. - Informed consent signed and dated.
2. - Male or female participant between ≥ 6 and < 12 years old.
3. - Spherical equivalent refractive error (SER) of at least -1.00D and no more than -6.00D in each eye as measured by cycloplegic autorefraction.
4. - IOP < 21mmHg in each eye.
5. - Distant BCVA equal or better than 0.1 LogMAR [≤ 0.1 LogMAR (equivalent to ≥ 20/25 Snellen)] in each eye.

Principal Exclusion Criteria:

Ophthalmic exclusion criteria in AT LEAST ONE EYE (1-11):

1. Known intolerance to administration of eye drops.
2. Astigmatism > 1.50D as measured by cycloplegic autorefraction.
3. Anisometropia ≥ 1.50D as measured by cycloplegic autorefraction.
4. Current or history of amblyopia or manifest strabismus including intermittent tropia.
5. Current or history of glaucoma.
6. Current or history of significant or severe damage to the cornea.
7. Presence of anterior segment pathology (e.g. iris malformation, cataract).
8. Presence of posterior segment or retinal pathology (dystrophies).
9. History of any disease or syndrome that predisposed the participant to severe myopia (e.g., Marfan syndrome, Stickler syndrome, retinopathy of prematurity).
10. History of non-axial cause of myopia (refractive or secondary myopia).
11. History of abnormal ocular refractive anatomy (e.g., keratoconus, keratoglobus, lenticonus, spherophakia).

Systemic/non-ophthalmic exclusion criteria (12-13):

12 - 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).

13- 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.

14- Specific exclusion criteria regarding sexually active individuals (14-15): Pregnancy for post-menarche participant (confirmed with a positive urine pregnancy test).

15- Adolescent of childbearing potential (male/female) who is sexually active and is not willing to use preventive measures.

Exclusion criteria related to general conditions (16-21):

16- Inability of participant and/or legal guardian(s) to understand the study procedures or to give informed consent.

17- Non-compliant participant and/or legal guardian(s) (e.g., not willing to attend a visit or a phone call or to complete the diary, way of life interfering with compliance).

18- Participation in this study at the same time as another clinical study. 19- Participation in this study within the 4 weeks after the end of a previous clinical study not related to myopia (or within 5 half-lives of the previously tested product if longer than 4 weeks).

20- Participant previously randomised in this study. 21- Participant being family member of the study sites or of the Laboratoires Théa company.

22- Exclusion criteria related to previous and concomitant treatments (medications/non-medicinal therapies/procedures): Participant with previous, current or anticipated prohibited listed treatment (or prohibited modification of treatment regimen).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: T10430 lower dose; The participant will be administered NaPB (lower concentration).	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).
Experimental: T10430 middle dose; The participant will be administered of NaPB (middle concentration).	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).
Experimental: T10430 higher dose; The participant will be administered of NaPB (higher concentration).	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).
Placebo Comparator: Vehicle; The participant will be administered an unpreserved ophthalmic solution without active substance.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of T10430 on Axial Length Change	Measurement of axial length changes in mm of the eyes (from the front [cornea] to the back [the retina]).	From the start of treatment to 6 months and 12 months of treatment.
Effectiveness of T10430 on Spherical Equivalent Refraction	Measurement of change in the focusing power of the eye, called spherical equivalent refraction, in D (Diopter).	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	Study doctors will record and assess any health events experienced by participants 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.

Collaborators and Investigators

• Sponsor: Laboratoires Thea

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: March 25, 2026
• First Submitted That Met QC Criteria: April 3, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Paediatric myopia
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: LT10430-201; 2025-521563-13-01 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No