Myopia
Conditions
Keywords
Paediatric myopia
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.
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.
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).
Sponsors
Laboratoires Thea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
Neither the participants nor the study doctors will know who is in which assigned group.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure of the occurrence of treatment-emergent adverse events (TEAEs). | 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. | 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
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of T10430 on Axial Length Change | From the start of treatment to 6 months and 12 months of treatment. | Measurement of axial length changes in mm of the eyes (from the front \[cornea\] to the back \[the retina\]). |
| Effectiveness of T10430 on Spherical Equivalent Refraction | From the start of treatment to 6 months and 12 months of treatment. | Measurement of change in the focusing power of the eye, called spherical equivalent refraction, in D (Diopter). |
| 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 doctors will record and assess any health events experienced by participants during physical and eye examinations. |
Countries
Jordan, South Africa, Tunisia
Contacts
CONTACTCorentin LE CAMUS
Outcome results
None listed