A Phase III, Randomized, Double-masked, Placebo-controlled, Parallel-group, Multicenter Study of the Safety and Efficacy of OT-101 (Atropine Sulfate 0.01%) in Treating the Progression of Myopia in Pediatric Subjects
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 678
- 试验地点
- 15
- 主要终点
- Percentage of study eyes with a -0.75D of progressive myopia defined as an increase in spherical equivalent of -0.75D or greater as assessed by cycloplegic autorefraction.
研究概览
简要总结
This is a phase III, randomized, double-masked, placebo-controlled, parallel-group, multicenter safety, tolerability, and efficacy study of atropine sulfate 0.01% (OT-101) as an investigational treatment for myopia in pediatric subjects
详细描述
This is a phase III, randomized, double-masked, placebo-controlled, parallel-group, multi-center study to evaluate the safety tolerability and efficacy of OT-101 (Atropine 0.01%) Ophthalmic Solution in treating the progression of myopia in pediatric subjects that will enroll approximately 678 pediatric subjects with myopia in total. Subjects will be stratified by age and refractive error.
This study consists of 11 visits over the course of approximately 4 years and can be broken down in the 3 stages: Screening (Days -14 to -1), Stage 1 (Day 1 to Year 3), and Stage 2 (Year 3 to Year 4). In stage 1, subjects will be randomized in a 2:1 manner to OT-101 Ophthalmic Solution: Placebo. Subjects will be dosed with one drop of study treatment per eye once daily at bedtime for 3 years. In stage 2, subjects will be re-randomization 1:1 will occur at Visit 9 (Month 36). At re-randomization, subjects who had been assigned to OT-101 Ophthalmic Solution will be randomized in a 1:1 ratio to continue on OT-101 Ophthalmic Solution or switch to placebo. Subjects who had been assigned to placebo will continue with placebo.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 3 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have refractive error by cycloplegic autorefraction at baseline (Visit 1) in the study eye of:
- •myopia greater or equal to -1.00D of spherical equivalent
- •astigmatism less than or equal to 1.50DC
- •progression of at least -0.50D of spherical equivalent in the last 12 months;
排除标准
- •Have active or a history of chronic or recurrent episodes of ocular inflammation (e.g. moderate to severe blepharitis, allergic conjunctivitis, peripheral ulcerative keratitis, scleritis) in either eye;
- •Have undergone any myopia control treatment including orthokeratology, rigid gas-permeable contact lenses, bifocal contact lenses, progressive addition spectacle lenses, or other lenses to reduce myopia progression in the previous 6 months. Myopic correction in the form of single-vision eyeglasses and/or single-vision soft contact lenses are allowed;
- •Have undergone any form of refractive eye surgery including incisional keratotomy, photorefractive keratectomy [PRK], laser in situ keratomileusis [LASIK], laser-assisted sub- epithelial keratectomy [LASEK]), corneal inlay procedures, conductive keratoplasty, small incision lenticule extraction (SMILE), cataract extraction, or any form of intraocular lens implantation;
研究组 & 干预措施
OT-101 alone
Atropine Sulfate 0.01% Ophthalmic Solution through year 4
干预措施: OT-101 Ophthalmic Solution (Drug)
OT-101 plus vehicle
Atropine Sulfate 0.01% Ophthalmic Solution through year 3 followed by vehicle for 1 year
干预措施: OT-101 Ophthalmic Solution (Drug)
OT-101 plus vehicle
Atropine Sulfate 0.01% Ophthalmic Solution through year 3 followed by vehicle for 1 year
干预措施: Vehicle (Drug)
Vehicle
Vehicle (Investigational Product minus active ingredient) through year 4
干预措施: Vehicle (Drug)
结局指标
主要结局
Percentage of study eyes with a -0.75D of progressive myopia defined as an increase in spherical equivalent of -0.75D or greater as assessed by cycloplegic autorefraction.
时间窗: At month 36
Efficacy of OT-101 Ophthalmic Solution
次要结局
- Change in spherical equivalent (D) in the study eye as assessed by cycloplegic autorefraction(Baseline to Month 36)
- Change in study eye axial length as measured by cycloplegic biometry (a standardized device will be selected for this study)(Baseline to Month 36)