A Clinical Comparison of Three Soft Daily Disposable Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Ocular Physiology
研究概览
简要总结
This study aims to compare the clinical performance of the somfilcon A, nelfilcon A II 2 and omafilcon A II 2 daily disposable contact lenses.
详细描述
This will be a randomised, subject-masked, crossover, bilateral study, controlled by cross comparison. Fifty subjects will use each lens type for a week in random sequence. Follow-up visits for each lens will be performed after one week of wear. Lenses will be worn on a daily wear, daily disposable wear schedule.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects will only be eligible for the study if:
- •They are of legal age (18) and 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 agree not to participate in other clinical research for the duration of this study.
- •They have a contact lens spherical prescription between -1.00 to - 6.00D (Diopters) (inclusive)
- •They have a spectacle cylindrical correction of -0.75D or less in each eye.
- •At dispensing, they can attain at least 0.10 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
- •They currently use soft contact lenses or have done so in the previous six months.
- •They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).
排除标准
- •Subjects will not be eligible to take part in the study if:
- •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 or ointment.
- •They have had cataract surgery.
- •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 breast-feeding.
- •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
somofilcon A
Subjects are randomized to wear somofilcon A for one week during the cross over study.
干预措施: somofilcon A (Device)
nelfilcon A II 2
Subjects are randomized to wear nelfilcon A II 2 for one week during the cross over study.
干预措施: nelfilcon A II 2 (Device)
omafilcon A ll 2
Subjects are randomized to wear omafilcon A ll 2 for one week during the cross over study.
干预措施: omafilcon A ll 2 (Device)
结局指标
主要结局
Ocular Physiology
时间窗: 1 week
Ocular physiology assessment of by biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
次要结局
- Lens Fit - Horizontal Centration(1 week)
- Lens Fit - Movement(1 week)
- Lens Fit - Corneal Coverage(1 week)
- Lens Surface - Deposition(1 week)
- Lens Surface - Wettability(1 week)
- Visual Acuity(1 week)
- Lens Fit - Vertical Centration(1 week)