Actively Recruiting
Safety and Efficacy of T10430 Eye Drops in Controlling Paediatric Myopia Progression
Led by Laboratoires Thea · Updated on 2026-04-13
200
Participants Needed
10
Research Sites
92 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy of T10430 Eye Drops in Controlling Paediatric Myopia Progression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Informed consent signed and dated.
- Male or female participant between 6 and < 12 years old.
- Nearsightedness with spherical equivalent refractive error (SER) between -1.00D and -6.00D in each eye.
- Eye pressure (IOP) less than 21mmHg in each eye.
- Distance best-corrected visual acuity (BCVA) equal or better than 0.1 LogMAR (20/25 Snellen) in each eye.
You will not qualify if you...
- Known intolerance to eye drop administration.
- Astigmatism greater than 1.50D.
- Difference in prescription between eyes (anisometropia) of 1.50D or more.
- Current or past amblyopia or manifest strabismus including intermittent tropia.
- Current or past glaucoma.
- Significant or severe corneal damage.
- Anterior segment eye problems (e.g., iris malformation, cataract).
- Posterior segment or retinal problems (dystrophies).
- History of diseases or syndromes causing severe myopia (e.g., Marfan syndrome, Stickler syndrome, retinopathy of prematurity).
- History of non-axial myopia causes (refractive or secondary myopia).
- History of abnormal eye anatomy (e.g., keratoconus, keratoglobus, lenticonus, spherophakia).
- Known or suspected allergy to study drug components or diagnostic agents used in the study.
- History or presence of systemic conditions interfering with safety or study results.
- Pregnancy in post-menarche participants.
- Sexually active adolescents not willing to use preventive measures.
- Inability of participant or guardian to understand study procedures or give consent.
- Non-compliance with study requirements.
- Participation in another clinical study currently or recently.
- Previously randomized in this study.
- Family member of study site staff or sponsor company.
- Use of prohibited treatments or changes in treatment regimen before or during the study.
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Abdali Hospital
Amman, Jordan
Not Yet Recruiting
2
Istiklal Hospital
Amman, Jordan
Not Yet Recruiting
3
Jordan University Hospital
Amman, Jordan
Not Yet Recruiting
4
Irbid Specialty Hospital
Irbid, Jordan
Not Yet Recruiting
5
Pharmaceutical research center at Jordan University of Science and Technology
Irbid, Jordan
Not Yet Recruiting
6
IATROS INTERNATIONAL PTY Ltd
Brandwag, South Africa
Actively Recruiting
7
Pretoria Eye Institute Research Foundation
Pretoria, South Africa
Actively Recruiting
8
Hôpital Universitaire Tahar Sfar Mahdia
Mahdia, Tunisia
Not Yet Recruiting
9
Hôpital Farhat-Hached
Sousse, Tunisia
Not Yet Recruiting
10
Hôpital Charles Nicolle
Tunis, Tunisia
Not Yet Recruiting
Research Team
C
Corentin LE CAMUS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
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