2025-521563-13-01招募中2 期
Safety and efficacy of T10430 eye drops in controlling paediatric myopia progression
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- 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).
研究概览
简要总结
To evaluate the ocular safety of T10430
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •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.
- •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): 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).
- •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.
- •Specific exclusion criteria regarding sexually active individuals (14-15): Pregnancy for post-menarche participant (confirmed with a positive urine pregnancy test).
- •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): Inability of participant and/or legal guardian(s) to understand the study procedures or to give informed consent.
- •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).
- •Participation in this study at the same time as another clinical study.
- •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).
- •Astigmatism > 1.50D as measured by cycloplegic autorefraction.
- •Participant previously randomised in this study.
- •Participant being family member of the study sites or of the Laboratoires Théa company.
- •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).
- •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).
研究组 & 干预措施
Preservative-free, ophthalmic solution
Placebo
干预措施: Preservative-free, ophthalmic solution (Drug)
null, null, null
Test
干预措施: null, null, null (Drug)
结局指标
主要结局
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).
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
- Change from baseline in Axial Length AL (mm) at 6 months and 12 months in both eyes.
- Change from baseline in cycloplegic spherical equivalent refractive error (SER) (D) at 6 months and 12 months in both eyes.
- Change from baseline in distant and near best-corrected visual acuity (BCVA at 1 month, 6 months, and 12 months in LogMAR in both eyes
- Score and change from baseline in conjunctival hyperemia at 1 month, 6 months, and 12 months in both eyes.
- Score and change from baseline in corneal fluorescein staining (CFS) at 1 month, 6 months, and 12 months in both eyes.
- Score and change from baseline in conjunctival fluorescein staining at 1 month, 6 months, and 12 months in both eyes.
- Change from baseline in TBUT (s) at 1 month, 6 months, and 12 months in both eyes.
- Change from baseline in IOP (mmHg) at 1 month, 6 months, and 12 months in both eyes.
- Change from baseline in central corneal thickness (µm) and in thinnest corneal thickness (µm) at 1 month, 6 months and 12 months in both eyes.
- Change from baseline in Biometry keratometry anterior chamber depth (ACD) (mm), lens thickness (LT) (mm), K1, K2 and Kmax in D, at 6 months and 12 months in both eyes.
- Change and relative change from baseline in central corneal endothelial cells (CEC) density (cell/mm2) at 1 month, 6 months and 12 months in both eyes.
- Hexagonality ratio of CEC (%) at 1 month, 6 months and 12 months in both eyes.
- Change from baseline in coefficient of variation (CV) of CEC size at 1 month, 6 months and 12 months in both eyes.
- Score of each ocular symptom throughout the day, total score of ocular symptoms and change from baseline in total score at all visits and phone calls.
- Score of each ocular symptom immediately after instillation and total score at all post-baseline visits and phone calls.
- Frequency of systemic TEAEs, serious systemic TEAEs, IMP-related systemic TEAEs, systemic TEAEs leading to premature IMP discontinuation by SOC and PT.
- Ocular tolerance assessed by the investigator at 1 month, 6 months and 12 months.
- Ocular tolerance assessed by the participant/relatives at all post-baseline visits and phone calls.
- Global satisfaction with the use of the single dose container assessed by the participant/legal guardian(s) at all post-baseline visits and phone calls.
研究者
Corentin LE CAMUS
Scientific
Laboratoires Thea
研究点 (2)
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