A Lifestyle Investigation With Spectacles and Daily Disposable Contact Lenses in Young Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 113
- 试验地点
- 2
- 主要终点
- Subjective Vision With Correction Type
研究概览
简要总结
The purpose of this study was to evaluate the relative benefits of daily disposable contact lenses versus spectacles in young adults.
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
- None
入排标准
- 年龄范围
- 13 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Understands rights as a research subject and willing and able to sign a Statement of Informed Consent, or if under 18, parent or guardian understands rights and is willing and able to sign a Statement of Informed Consent.
- •Willing and able to follow the protocol.
- •Currently wearing spectacles full-time (at least five days per week, eight hours per day).
- •Has never worn contact lenses (more than one day) before.
- •Agrees to not participate in other clinical research for the duration of this study.
- •Can attain at least 6/9 in each eye with the study optical correction.
- •Can be fitted with study lenses in the available power range (contact lens group) or can select a satisfactory spectacle lens frame and lenses (spectacle group).
- •Willing and able to wear the study lenses or spectacles for a minimum of five days per week, eight hours per day.
- •Owns or has regular access to a mobile phone and is familiar with SMS text messaging.
- •Has an up-to-date and functional pair of spectacles at time of enrollment.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Has an ocular or systemic disorder that would normally contraindicate contact lens wear.
- •Is using any topical medication such as eye drops or ointment.
- •Has had corneal refractive surgery.
- •Has had cataract surgery.
- •Has diabetes.
- •Has taken part in other clinical research within two weeks of starting the study.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Subjective Vision With Correction Type
时间窗: Month 6
Participant responded to an SMS message: "Please rate your happiness (H) and vision (V) with your \[contact lenses/spectacles\]: 1=very poor; 2=poor; 3=neither; 4=good; and 5=very good. eg H2V4. Please send N if in you are not wearing \[contact lenses/spectacles\]."
Subjective Happiness With Correction Type
时间窗: Month 6
Participant responded to an SMS message: "Please rate your happiness (H) and vision (V) with your \[contact lenses/spectacles\]: 1=very poor; 2=poor; 3=neither; 4=good; and 5=very good. eg H2V4. Please send N if in you are not wearing \[contact lenses/spectacles\]."
次要结局
未报告次要终点