Vision Stability and Preference for Soft Toric vs. Soft Spherical Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Vision Stability While Doing Tasks on Mobile Phone
研究概览
简要总结
The principal hypothesis is to be tested in this work is that vision stability (the primary outcome measure) with a spherical contact lens correction vs. a toric contact lens correction will be the same.
详细描述
This will be a randomised, subject-masked, crossover, bilateral non-dispensing study, controlled by cross-comparison. Thirty subjects will use each lens type at a single visit in random sequence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •They are aged 18-35 years and have capacity to volunteer.
- •They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
- •They are willing and able to follow the protocol.
- •They are an existing wearer of soft spherical contact lenses in both eyes.
- •They have a spherical component of their spectacle refractive error between
- •0.50DS and -6.50DS in both eyes.
- •They have a cylindrical component of their spectacle refractive error between
- •0.75DC and -1.25DC in both eyes.
- •They can be fitted satisfactorily with both lens types.
- •They own an acceptable pair of spectacles.
- •They agree not to participate in other clinical research for the duration of the study.
排除标准
- •They have an ocular disorder which would normally contra-indicate contact lens wear.
- •They have a systemic disorder which would normally contra-indicate contact lens wear.
- •They are using any topical medication such as eye drops (including comfort drops) or ointment on a regular basis.
- •They are aphakic.
- •They have had corneal refractive surgery.
- •They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
- •They are pregnant or breastfeeding.
- •They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
- •They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.
- •They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
研究组 & 干预措施
Test Contact lens
Subjects will be randomized to wear test lenses for 30 minutes, and then cross-over to control lenses.
干预措施: Test Contact lens (Device)
Test Contact lens
Subjects will be randomized to wear test lenses for 30 minutes, and then cross-over to control lenses.
干预措施: Control Contact lens (Device)
Control Contact lens
Subjects will be randomized to wear control lenses for 30 minutes, and then cross-over to test lenses.
干预措施: Test Contact lens (Device)
Control Contact lens
Subjects will be randomized to wear control lenses for 30 minutes, and then cross-over to test lenses.
干预措施: Control Contact lens (Device)
结局指标
主要结局
Vision Stability While Doing Tasks on Mobile Phone
时间窗: 30 minutes
Vision stability was assessed by study subjects while doing tasks on mobile phone using a 0-100 visual analogue scales (0 - Unacceptable. Lens cannot be worn, 100 - Excellent. Unaware of any visual loss)
Vision Stability While Walking
时间窗: 30 minutes
Vision stability was assessed by study subjects while walking using a 0-100 visual analogue scales (0 - Unacceptable. Lens cannot be worn, 100 - Excellent. Unaware of any visual loss)
Vision Stability While Doing Tasks on Desktop
时间窗: 30 minutes
Vision stability was assessed by study subjects while doing tasks on desktop using a 0-100 visual analogue scales (0 - Unacceptable. Lens cannot be worn, 100 - Excellent. Unaware of any visual loss)
次要结局
- Lens Fit(30 minutes)
- Lens Fit for Test Contact Lens(10 minutes)