A Multicenter, Double-Masked, Randomized, Placebo-Controlled Phase 3 Study of the Safety and Efficacy of Atropine 0.1% and 0.01% Ophthalmic Solutions Administered With a Microdose Dispenser for the Reduction of Pediatric Myopia Progression (The CHAPERONE Study)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 438
- 试验地点
- 17
- 主要终点
- Myopia progression
研究概览
简要总结
This study evaluates the progression of myopia in participants using microdosed atropine 0.01%, atropine 0.1%, or placebo ophthalmic solution. Eligible subjects will administer study medication daily in each eye for 48 months. Efficacy and safety assessments will be performed at visits scheduled for 1, 6, 12, 18, 24, 30 and 36 months after initiation of medication use. Subjects will be re-randomized at the 36 month visit, then followed at 6 month intervals for an additional year.
详细描述
Subjects will be evaluated for eligibility during an initial Screening Visit and enrolled after signing the study-specific informed consent form(s). Eligible subjects must complete a run-in period where they use the microdose dispenser to administer study drug "vehicle" solution daily in both eyes. After run-in, subjects return for a Baseline Visit and additional study eligibility assessments. Subjects who continue to be eligible will be equally randomized to one of the following treatment groups:
- Microdose atropine 0.1% ophthalmic solution
- Microdose atropine 0.01% ophthalmic solution
- Microdose placebo ophthalmic solution
Randomization will be stratified by iris color (e.g., dark and light) and study site. Study enrollment will be limited to a maximum of 50% of subjects who self-identify as East Asian ethnicity. Subjects will use their assigned study medication daily in both eyes and return for efficacy and safety assessments at 1, 6, 12, 18, 24, 30, and 36 months.
At the Month 36 Visit, subjects in the 2 atropine dose arms will be re-randomized to either placebo or 1 of the 2 doses of atropine ophthalmic solution, while subjects originally assigned to placebo will be re-randomized to one of the 2 atropine ophthalmic solution arms. After re-randomization, all subjects will be followed for an additional year with efficacy and safety examinations at Months 42 and 48.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
There will be no differences in the presentation of study drug administered. All study personnel conducting ophthalmic assessments will be masked to treatment assignment.
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Refractive error by cycloplegic autorefraction: myopia -1.00 D to -6.00 D in both eyes; astigmatism ≤ 1.50 D in both eyes; anisometropia < 1.50 D.
- •Best-corrected distance visual acuity in current correction of 0.2 logMAR or better with interocular difference ≤ 0.1 logMAR.
- •Refractive correction for each eye meets the following criteria: myopia within ± 0.50 D of the manifest refraction at the Screening Visit; cylinder power within ± 0.50 D of the manifest refraction at the Screening Visit; when cylinder power is < 1.00 D, axis within ± 15 degrees of the manifest refraction; when cylinder power is ≥ 1.00 D, axis within ± 5 degrees of the manifest refraction.
排除标准
- •Current or previous myopia treatment with non-study atropine, pirenzepine or other topical anti-muscarinic agent.
- •Current use of bifocals, progressive-addition lenses, or multifocal soft contact lenses.
- •Use of rigid gas permeable lenses, including orthokeratology lenses within 90 days of Screening.
- •Known atropine allergy.
- •Abnormality of the cornea, lens, central retina, iris or ciliary body.
- •Current or prior history of manifest strabismus, amblyopia, or nystagmus.
- •Prior eyelid, strabismus, intraocular, or refractive surgery.
- •Intraocular pressure > 26 mmHg.
- •History of premature birth by parent's report.
- •Inability to perform protocol-prescribed testing due to preexisting neurological diagnoses, genetic syndrome, or other issues.
- •Medical conditions predisposing patient to degenerative myopia, abnormal ocular refractive anatomy, and/or any history of intraocular surgery.
- •Any systemic disease or condition that may affect visual function or development such as diabetes mellitus.
- •Any ocular inflammation or external ocular inflammation within 30 days of Screening.
- •History of punctal occlusion.
- •Heterochromia.
- •Lid squeezers.
- •Participation in any study of an investigational, interventional product within 30 days prior to Screening Visit.
- •Immediate family member of study staff designed to perform study evaluations or procedures.
- •Pregnancy, or if sexually active, unwillingness to use an acceptable form of contraception during the study.
- •Presence of a severe/serious ocular condition or any other unstable medical condition that, in the Investigator's opinion, may preclude study treatment or follow-up.
研究组 & 干预措施
Atropine 0.1% Ophthalmic Solution
Atropine 0.1% ophthalmic solution administered daily in both eyes using a microdose dispenser
干预措施: Atropine 0.1% Ophthalmic Solution (Drug)
Atropine 0.01% Ophthalmic Solution
Atropine 0.01% ophthalmic solution administered daily in both eyes using a microdose dispenser
干预措施: Atropine 0.01% Ophthalmic Solution (Drug)
Placebo Ophthalmic Solution
Placebo ophthalmic solution administered daily in both eyes using a microdose dispenser
干预措施: Placebo Ophthalmic Solution (Drug)
结局指标
主要结局
Myopia progression
时间窗: 36 Months
The proportion of primary study eyes showing less than 0.50 D (spherical equivalent) myopia progression compared to baseline measured using cycloplegic autorefraction.
次要结局
未报告次要终点