NCT05159765进行中（未招募）不适用
Progressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 144
- 试验地点
- 14
- 主要终点
- Change in Refractive Error relative to Baseline
研究概览
简要总结
This is a multi-center, randomized, double-masked clinical trial. All study devices are market approved/cleared in the localities where the study is conducted. Subjects will be randomly assigned to wear NaturalVue Sphere single vision contact lenses (SVCL) or NaturalVue Multifocal (NVMF) soft contact lenses for a total of three years.
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
- 7 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, aged 7 to <13 (inclusive) at the Screening/Baseline examination.
- •Meet the following refractive criteria determined by cycloplegic autorefraction at Screening/Baseline:
- •Spherical Equivalent Refractive Error (SERE): between -0.75 and -5.00 D inclusive.
- •Astigmatism: ≤ -0.75 D
- •Anisometropia: < 1.000
排除标准
- •Has previously worn or currently wears rigid or gas permeable contact lenses, including orthokeratology lenses,
- •Appears to exhibit poor personal hygiene, that, in the Investigator's opinion, might prevent safe contact lens wear.
- •Is currently, or within 30 days prior to this study has been, an active participant in another clinical study.
- •Current or prior use of bifocals, progressive addition lenses, atropine, pirenzepine, multifocal or specialized contact lenses, or ANY other myopia control treatment.
- •The Investigator for any reason considers that it is not in the best interest of the subject to participate in the study, including if the child is not mature enough to independently handle and care for soft contact lenses.
结局指标
主要结局
Change in Refractive Error relative to Baseline
时间窗: Baseline, 12, 24, 36 months
Mean change in cycloplegic auto-refraction (D)
次要结局
- Change in Axial Length(Baseline,12, 24, 36 months)
研究者
研究点 (14)
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