MyopiaPhase 2NCT07522242
Safety and Efficacy of T10430 Eye Drops in Controlling Paediatric Myopia Progression
A Phase 2 study testing T10430 lower dose, T10430 middle dose and T10430 higher dose in people with Myopia, run by Laboratoires Thea at 10 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Myopia
- What is being tested?
- T10430 lower dose, T10430 middle dose and T10430 higher dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 21 Jan 2026to Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- 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).
Trial locations and contacts
10 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 3 countries
Jordan5 sites, 5 recruiting
- Not yet recruiting
Abdali Hospital
Amman
- Not yet recruiting
Istiklal Hospital
Amman
- Not yet recruiting
Jordan University Hospital
Amman
- Not yet recruiting
Irbid Specialty Hospital
Irbid
- Not yet recruiting
Pharmaceutical research center at Jordan University of Science and Technology
Irbid
Tunisia3 sites, 3 recruiting
- Not yet recruiting
Hôpital Universitaire Tahar Sfar Mahdia
Mahdia
- Not yet recruiting
Hôpital Farhat-Hached
Sousse
- Not yet recruiting
Hôpital Charles Nicolle
Tunis
South Africa2 sites, 2 recruiting
- Recruiting
IATROS INTERNATIONAL PTY Ltd
Brandwag
- Recruiting
Pretoria Eye Institute Research Foundation
Pretoria
About this study
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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T10430 lower doseDrug
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 doseDrug
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 doseDrug
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).
VehicleDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| T10430 lower dose | Experimental | The participant will be administered NaPB (lower concentration). Receives: Drug: T10430 lower dose |
| T10430 middle dose | Experimental | The participant will be administered of NaPB (middle concentration). Receives: Drug: T10430 middle dose |
| T10430 higher dose | Experimental | The participant will be administered of NaPB (higher concentration). Receives: Drug: T10430 higher dose |
| Vehicle | Placebo comparator | The participant will be administered an unpreserved ophthalmic solution without active substance. Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measurement of axial length changes in mm of the eyes (from the front [cornea] to the back [the retina]).
Measured: 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).
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start21 Jan 2026
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratoires Thea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07522242
- Sponsor's protocol ID
- LT10430-201
- Other IDs
- 2025-521563-13-01, 2025
- Status last verified
- Apr 2026
- First submitted
- 25 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of T10430 Eye Drops in Controlling Paediatric Myopia Progression
- ClinicalTrials.gov ID
- NCT07522242
- Acronym / sponsor ID
- LT10430-201
- Conditions
- Myopia
- Keywords
- Paediatric myopia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Laboratoires TheaIndustry (pharma, biotech, devices)
- Study start
- 21 Jan 2026 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| T10430 lower dose | Experimental | Drug: T10430 lower doseThe participant will be administered NaPB (lower concentration). |
| T10430 middle dose | Experimental | Drug: T10430 middle doseThe participant will be administered of NaPB (middle concentration). |
| T10430 higher dose | Experimental | Drug: T10430 higher doseThe participant will be administered of NaPB (higher concentration). |
| Vehicle | Placebo comparator | Drug: VehicleThe participant will be administered an unpreserved ophthalmic solution without active substance. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T10430 lower doseThe 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). | Drug | T10430 lower dose |
| T10430 middle doseThe 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). | Drug | T10430 middle dose |
| T10430 higher doseThe 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). | Drug | T10430 higher dose |
| VehicleThe 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). | Drug | Vehicle |
Primary outcome
Measure of the occurrence of treatment-emergent adverse events (TEAEs).
Time frame: 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).
3 secondary outcomes
Effectiveness of T10430 on Axial Length Change
Time frame: From the start of treatment to 6 months and 12 months of treatment.
Effectiveness of T10430 on Spherical Equivalent Refraction
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing T10430 lower dose, T10430 middle dose and T10430 higher dose in people with Myopia, run by Laboratoires Thea at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Jordan, Tunisia, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Corentin LE CAMUS (+33473981436, corentin.lecamus@theapharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of the occurrence of treatment-emergent adverse events (TEAEs). (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.