2023-510439-13-00招募中3 期
A phase III, randomized, double blind, multiple doses, placebo-controlled parallel-group, adaptive study to evaluate the efficacy of atropine to treat the progression of myopia in children and adolescents from 3 to less than 18 years of age (MODERATO Study)
Ocus Innovation Ireland Limited7 个研究点 分布在 3 个国家目标入组 137 人开始时间: 2025年1月10日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 137
- 试验地点
- 7
- 主要终点
- Mean annual rate of progression of myopia (D/year) based on spherical equivalent (SE) measured by cycloplegic autorefraction through 24 months.
研究概览
简要总结
To evaluate the efficacy of atropine eyedrops at two concentrations, 0.025% and 0.05%, over a 24-month treatment period, in slowing the progression of myopia in children and adolescents from 3 to 18 years old.
研究设计
- 分配方式
- Randomized
- 主要目的
- Moderato Study
- 盲法
- Double (Investigator, Subject)
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects from 3 to less than 18 years of age.
- •Subjects showing myopia with a SER of both eyes at least -0.75 D at baseline.
- •Intraocular pressure ≤ 21 mm Hg in each eye.
- •Parents or legal representative who have been informed about the clinical trial and have signed the informed consent form, with the exception of subjects aged over 16 years only in the UK, who can provide their own consent, according to the local regulations.
- •Female adolescents with childbearing potential (after menarche) following a negative urine dipstick pregnancy test.
- •Adolescent females with childbearing potential or males who are sexually active and using a highly effective birth control method.
排除标准
- •Anisometropia, meaning a significant difference in refractive power between the two eyes exceeding |1.5| D.
- •Pregnancy or breastfeeding.
- •Previous or current alcohol or drug abuse.
- •Mental or emotional instability that might jeopardize the compliance with the trial procedures.
- •Unreliability or lack of cooperation.
- •History of any myopia control treatment within 3 months before inclusion: e.g. peripheral-plus or diffusion-optics-technology glasses, orthokeratology contact lenses, peripheral-plus/multifocal contact lenses, atropine eyedrops.
- •Other reasons why, in the opinion of the investigator, the subjects should not participate in the trial.
- •Patients who have consented to participate in the clinical trial, but do not meet one or more eligibility criteria required for participation in the trial during the screening procedures, and subsequently are not randomly assigned to the study treatment or entered in the study, are considered screening failures.
- •Refractive astigmatism (ΔTK) > |1.5| D.
- •Presence of ocular pathologies such as pathological myopia, corneal scars, or other anterior or posterior eye pathologies.
- •History of amblyopia or strabismus.
- •Presence of a history of a retinal dystrophy or systemic disorder that may predispose to severe myopia (e.g., Marfan syndrome, retinitis pigmentosa, Stickler syndrome, retinopathy of prematurity)
- •Abnormal ocular biometry aside from axial length (e.g., keratoconus, lenticonus, spherophakia) or previous intraocular or ocular laser/non-laser surgery.
- •History of glaucoma; anatomic narrow anterior chamber angles.
- •Down syndrome or spastic paralysis.
- •Known intolerances to atropine eye drops, allergies against eye drops.
结局指标
主要结局
Mean annual rate of progression of myopia (D/year) based on spherical equivalent (SE) measured by cycloplegic autorefraction through 24 months.
Mean annual rate of progression of myopia (D/year) based on spherical equivalent (SE) measured by cycloplegic autorefraction through 24 months.
次要结局
- Number and percentage of early escape patients at 6 months.
- Mean change in axial length and glasses prescription at 3, 6, 12, 18 and 24 months.
- Safety at 3, 6, 12, 18 and 24 months, measuring: % children requiring photochromic and/or varifocal lenses counts and percentage of patients reporting any AEs change in photosensitivity index best corrected distance and near visual acuity pupil size and accommodation amplitude
- Vision-related quality of life.
- Acceptability of the formulation: it will be assessed with a 3-item questionnaire, scored on a six-point scale.
- Overall between-group difference from baseline in the proportion of subjects who show < -0.50 D myopia progression (Spherical Equivalent Refraction, SER) at 24 months: Chi-square test, or Fisher's exact test, will be used to test for differences among three treatment groups in the proportion of subjects who show < -0.50 D myopia progression (SER) at 24 months.
研究者
Annegret Dahlmann-Noor
Scientific
Ocus Innovation Ireland Limited
研究点 (7)
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