A Multicenter, Randomized, Double-masked, Vehicle-controlled Study to Assess the Safety and Efficacy of SYD-101 Ophthalmic Solution for the Treatment of Myopia in Children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 852
- 试验地点
- 47
- 主要终点
- Myopic progression >0.75 D (diopters)
研究概览
简要总结
Myopia, or nearsightedness, is the most common eye disorder, often affecting more than 40% of adults in Europe, Asia and the USA. Severe myopia is associated with an increased risk of developing other eye conditions such as glucoma, cataracts and retinal detachment, which may lead to blindness. Early treatment of myopia in children could help slow the condition and minimize the risk of complications later in life. This study investigates the use of SYD-101, an eye solution, in slowing-down the progression of myopia in children.
详细描述
This will be a 3-arm, multicentered, randomized, double-masked, vehicle-controlled study conducted in 2 parts.
Part 1 is the primary treatment period of 3 years, during which participants will receive 1 of 3 masked medications.
Part 2 is the randomized withdrawal period of 1 year, during which participants originally receiving Vehicle will receive SYD-101, and participants originally receiving SYD-101 will receive either Vehicle or SYD-101.
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)
入排标准
- 年龄范围
- 3 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Myopia of 0.5 D (diopters) to 6.00 D (inclusive) in both eyes.
- •Astigmatism ≤1.50 D in both eyes.
- •Anisometropia ≤1.00 D in both eyes.
- •If myopia is ≥0.75 D, participant must be wearing single vision eyeglasses or soft, daily-wear, single-vision contact lenses that meet study investigator's criteria.
- •BCVA (best-corrected visual acuity) Snellen equivalent of 20/32 or better.
排除标准
- •Participants with a history or current evidence of a medical condition predisposing them to degenerative myopia (e.g. Marfan syndrome, Stickler syndrome), or a condition that may affect visual function or development (e.g. diabetes mellitus, chromosome anomaly).
- •Current use of a monoamine oxidase inhibitor.
- •Evidence of any ocular inflammation or infection in either eye, including blepharitis, conjunctivitis, keratitis, and scleritis.
- •Past, present or future plans to use orthokeratology (orthoK), rigid gas-permeable, bifocal, progressive-addition, multi-focal, or other lenses to reduce myopia progression; or the use of atropine, pirenzepine or other anti-muscarinic agent for myopia.
- •History or evidence of ocular surgery or planned future ocular surgery in either eye.
- •Other protocol-defined inclusion/exclusion criteria could apply.
研究组 & 干预措施
Vehicle
1 drop in each eye at bedtime. Part 1: participants will be randomized to Vehicle Part 2: participants will be re-randomized to SYD-101 0.03%
干预措施: Vehicle (Drug)
SYD-101 0.01%
1 drop in each eye at bedtime. Part 1: participants will be randomized to SYD-101 0.01% Part 2: participants will be re-randomized to SYD-101 0.01% or Vehicle
干预措施: SYD-101 0.01% (Drug)
SYD-101 0.03%
1 drop in each eye at bedtime. Part 1: participants will be randomized to SYD-101 0.03% Part 2: participants will be re-randomized to SYD-101 0.03% or Vehicle
干预措施: SYD-101 0.03% (Drug)
结局指标
主要结局
Myopic progression >0.75 D (diopters)
时间窗: Month 36
Proportion of participants with confirmed myopic progression \>0.75 D (diopters), based on SE (spherical equivalent) as measured by cycloplegic autorefraction
Myopic Progression <-0.75 D (Diopters)
时间窗: Month 36
Proportion of participants with confirmed myopic progression \<-0.75 D (diopters), based on SE (spherical equivalent) as measured by cycloplegic autorefraction
次要结局
- Proportion of participants with annual myopia progression rate > 0.50 D/year(Month 36)
- Time to progression of myopia >0.75 D (diopters)(Up to 36 months (from date of randomization until date myopia progresses >0.75 D))
- Proportion of participants with annual myopia progression rate <=0.50 D/year(Through Month 36)
- Mean annual myopic progression(Month 36)
- Proportion of participants with annual myopia progression rate <=0.25 D/year(Through Month 36)
- Mean Annual Myopic Progression(Month 36)
- Proportion of Participants With Annual Myopia Progression Rate >=-0.50 D/Year(Through Month 36)
- Proportion of Participants With Annual Myopia Progression Rate >=-0.25 D/Year(Through Month 36)
- Proportion of Participants With Increase of Myopia More Than -0.50 D(Month 36)
- Time to Progression of Myopia <-0.75 D (Diopters)(Up to 36 months (from date of randomization until date myopia progresses < -0.75 D))
- Mean Change From Baseline in Axial Length (Subset Only)(Baseline to Month 36)
- Mean change from baseline in axial length (subset only)(Baseline to Month 36)