The Clinical Comparison of Narafilcon A and Stenfilcon A Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 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 and subjective acceptance of the narafilcon A lens with the stenfilcon A lens when used on a daily wear, daily disposable basis.
详细描述
This will be a randomized, subject-masked, crossover, bilateral study, controlled by cross comparison. Seventy subjects will use each lens type for a week in a 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.
- •They can be satisfactorily fitted with the study lens types.
- •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 six days per week and for at least eight hours per day).
- •They own a wearable pair of spectacles.
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.
- •They currently wear either the stenfilcon A lens or narafilcon A lens.
研究组 & 干预措施
narafilcon A
Participants are randomized to wear narafilcon A lens pair for one week during the cross over study.
干预措施: narafilcon A (Device)
stenfilcon A
Participants are randomized to wear stenfilcon A lens pair for one week during the cross over study.
干预措施: stenfilcon A (Device)
结局指标
主要结局
Ocular Physiology
时间窗: 1 week
Ocular physiology assessment of narafilcon A and stenfilcon A lenses by biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Visual Acuity
时间窗: 1 week
Visual acuity for narafilcon A and stenfilcon A are assessed by LogMAR. High contrast is measured with black letters on a white background. Low contrast is measured with gray letters on a white background.
Comfort Level of Stenfilcon A and Narafilcon A Lenses
时间窗: 1 week
Subjective responses for overall comfort will be evaluated for each pair using questionnaire (Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).
Dryness of Stenfilcon A and Narafilcon A Lenses
时间窗: 1 week
Subjective responses for dryness will be evaluated for each pair using questionnaire (Scale 0-100, 0=extremely poor, high levels of dryness, 100=excellent, no dryness).
Vision of Stenfilcon A and Narafilcon A Lenses
时间窗: 1 week
Subjective responses for vision will be evaluated for each pair using questionnaire (Scale 0-100, 0=unacceptable, lens cannot be worn, 100=excellent).
Lens Surface - Deposition on Stenfilcon A and Narafilcon A Lenses
时间窗: 1 week
Lens surface for narafilcon A and stenfilcon A is assessed. (Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe)
Lens Surface - Wettability of Stenfilcon A and Narafilcon A Lenses
时间窗: 1 week
Lens wettability for narafilcon A and stenfilcon A is assessed. (Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe)
Lens Fit - Horizontal Centration of Stenfilcon A and Narafilcon A Lenses
时间窗: 1 week
Horizontal centration assessed for narafilcon A and stenfilcon A lenses categorized as extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal.
Lens Fit - Vertical Centration of Stenfilcon A and Narafilcon A Lenses
时间窗: 1 week
Vertical centration assessed for narafilcon A and stenfilcon A lenses and graded as extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal.
Lens Fit - Corneal Coverage of Stenfilcon A and Narafilcon A Lenses
时间窗: 1 week
Corneal coverage will be assessed for narafilcon A and stenfilcon A and categorized as extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.
Lens Movement
时间窗: 1 week
Lens movement assessed for narafilcon A and senofilcon A lenses and categorized as extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.
次要结局
未报告次要终点