T10430 eye drops to slow childhood myopia progression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial will enroll about 200 children (ages 6–11) with axial myopia to receive one of three doses of T10430 eye drops or a placebo (vehicle). Participants will be randomized to a treatment arm and followed with eye exams to monitor safety and changes in refraction and eye growth. The trial builds on positive animal safety data for drugs with a similar mechanism and aims to identify a dose range with acceptable safety and signs of efficacy. Study visits will occur at one of three participating hospitals in Amman, Jordan.

Why it matters

Who can join: the full rules

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).

Where it's running

• IATROS INTERNATIONAL PTY Ltd
  Brandwag, South Africa Recruiting
• Pretoria Eye Institute Research Foundation
  Pretoria, South Africa Recruiting
• 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

Study contacts

• Study coordinator: Corentin LE CAMUS
• Email: corentin.lecamus@theapharma.com
• Phone: +33473981436

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.