Safety and efficacy of T10430 eye drops in controlling paediatric myopia progression

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Laboratoires Thea

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Decision date (initial)

2026-05-22

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Laboratoires Théa

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To evaluate the ocular safety of T10430

Secondary objectives 2

1. To evaluate the preliminary efficacy data of T10430
2. To evaluate the safety of T10430

Conditions and MedDRA coding

Paediatric myopia

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

EMA paediatric investigation plan (PIP)

EMEA-000024-PIP88-11

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

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.

Exclusion criteria 22

1. Ophthalmic exclusion criteria in AT LEAST ONE EYE (1-11): 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).
12. Systemic/non-ophthalmic exclusion criteria (12-13): 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.
16. Exclusion criteria related to general conditions (16-21): 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).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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).

Secondary endpoints 19

1. Change from baseline in Axial Length AL (mm) at 6 months and 12 months in both eyes.
2. Change from baseline in cycloplegic spherical equivalent refractive error (SER) (D) at 6 months and 12 months in both eyes.
3. Change from baseline in distant and near best-corrected visual acuity (BCVA at 1 month, 6 months, and 12 months in LogMAR in both eyes
4. Score and change from baseline in conjunctival hyperemia at 1 month, 6 months, and 12 months in both eyes.
5. Score and change from baseline in corneal fluorescein staining (CFS) at 1 month, 6 months, and 12 months in both eyes.
6. Score and change from baseline in conjunctival fluorescein staining at 1 month, 6 months, and 12 months in both eyes.
7. Change from baseline in TBUT (s) at 1 month, 6 months, and 12 months in both eyes.
8. Change from baseline in IOP (mmHg) at 1 month, 6 months, and 12 months in both eyes.
9. Change from baseline in central corneal thickness (µm) and in thinnest corneal thickness (µm) at 1 month, 6 months and 12 months in both eyes.
10. Change from baseline in Biometry keratometry anterior chamber depth (ACD) (mm), lens thickness (LT) (mm), K1, K2 and Kmax in D, at 6 months and 12 months in both eyes.
11. Change and relative change from baseline in central corneal endothelial cells (CEC) density (cell/mm2) at 1 month, 6 months and 12 months in both eyes.
12. Hexagonality ratio of CEC (%) at 1 month, 6 months and 12 months in both eyes.
13. Change from baseline in coefficient of variation (CV) of CEC size at 1 month, 6 months and 12 months in both eyes.
14. Score of each ocular symptom throughout the day, total score of ocular symptoms and change from baseline in total score at all visits and phone calls.
15. Score of each ocular symptom immediately after instillation and total score at all post-baseline visits and phone calls.
16. Frequency of systemic TEAEs, serious systemic TEAEs, IMP-related systemic TEAEs, systemic TEAEs leading to premature IMP discontinuation by SOC and PT.
17. Ocular tolerance assessed by the investigator at 1 month, 6 months and 12 months.
18. Ocular tolerance assessed by the participant/relatives at all post-baseline visits and phone calls.
19. Global satisfaction with the use of the single dose container assessed by the participant/legal guardian(s) at all post-baseline visits and phone calls.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Laboratoires Thea

Sponsor organisation

Laboratoires Thea

Address

Zone Industrielle Du Brezet, 12 Rue Louis Bleriot 12 Rue Louis Bleriot

City

Clermont Ferrand

Postcode

63100

Country

France

Scientific contact point

Organisation

Laboratoires Thea

Contact name

Corentin LE CAMUS

Public contact point

Organisation

Laboratoires Thea

Contact name

Corentin LE CAMUS

Third parties 3

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications