Safety and Efficacy of T10430 Eye Drops in Controlling Paediatric Myopia Progression
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 10
- 主要终点
- Measure of the occurrence of treatment-emergent adverse events (TEAEs).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
Neither the participants nor the study doctors will know who is in which assigned group.
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Principal Inclusion Criteria:
- •- Informed consent signed and dated.
- •- Male or female participant between ≥ 6 and < 12 years old.
- •- Spherical equivalent refractive error (SER) of at least -1.00D and no more than -6.00D in each eye as measured by cycloplegic autorefraction.
- •- IOP < 21mmHg in each eye.
- •- Distant BCVA equal or better than 0.1 LogMAR [≤ 0.1 LogMAR (equivalent to ≥ 20/25 Snellen)] in each eye.
排除标准
- •Ophthalmic exclusion criteria in AT LEAST ONE EYE (1-11):
- •Known intolerance to administration of eye drops.
- •Astigmatism > 1.50D as measured by cycloplegic autorefraction.
- •Anisometropia ≥ 1.50D as measured by cycloplegic autorefraction.
- •Current or history of amblyopia or manifest strabismus including intermittent tropia.
- •Current or history of glaucoma.
- •Current or history of significant or severe damage to the cornea.
- •Presence of anterior segment pathology (e.g. iris malformation, cataract).
- •Presence of posterior segment or retinal pathology (dystrophies).
- •History of any disease or syndrome that predisposed the participant to severe myopia (e.g., Marfan syndrome, Stickler syndrome, retinopathy of prematurity).
- •History of non-axial cause of myopia (refractive or secondary myopia).
- •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).
研究组 & 干预措施
T10430 lower dose
The participant will be administered NaPB (lower concentration).
干预措施: T10430 lower dose (Drug)
T10430 middle dose
The participant will be administered of NaPB (middle concentration).
干预措施: T10430 middle dose (Drug)
T10430 higher dose
The participant will be administered of NaPB (higher concentration).
干预措施: T10430 higher dose (Drug)
Vehicle
The participant will be administered an unpreserved ophthalmic solution without active substance.
干预措施: Vehicle (Drug)
结局指标
主要结局
Measure of the occurrence of treatment-emergent adverse events (TEAEs).
时间窗: 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).
次要结局
- Effectiveness of T10430 on Axial Length Change(From the start of treatment to 6 months and 12 months of treatment.)
- Effectiveness of T10430 on Spherical Equivalent Refraction(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(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.)