The Clinical Comparison of Senofilcon A and Stenfilcon A Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Dryness
研究概览
简要总结
The objective of this study is to compare the clinical performance of senofilcon A lens with the stenfilcon A lens each for one week of daily disposable wear.
详细描述
The purpose of this bilateral cross-over study is to evaluate the clinical performance of senofilcon A lens with the stenfilcon A lens. In particular, the study will focus on ocular physiology, lens fit, lens surface, visual acuity, and subjective response.
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 (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 six 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 lactating.
- •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 MyDay (daily) or the Acuvue Oasys (2 weekly) lens.
研究组 & 干预措施
Senofilcon A
Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.
干预措施: Senofilcon A (Device)
Stenfilcon A
Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.
干预措施: Stenfilcon A (Device)
结局指标
主要结局
Dryness
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
时间窗: Baseline and 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.
Overall Subjective Score of Lenses
时间窗: Baseline and 1 week
Subjective responses will be evaluated for each pair using questionnaire. Scale 0-100, 0=extremely poor, 100=excellent.
Comfort
时间窗: Baseline and 1 week
Subjective responses for comfort will be evaluated for each pair using questionnaire. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.
Ocular Physiology
时间窗: Baseline and 1 week
Ocular physiology assessment of senofilcon A and stenfilcon A lenses by biomicroscopy for the following: corneal staining, conjunctival hyperaemia, limbal hyperaemia, and conjunctival staining. Scale 0-4, 0.25 steps, 0=normal, 4=severe.
次要结局
- Lens Surface - Wettability(1 week)
- Vertical Centration(1 Week)
- Lens Surface - Debris(1 week)
- Lens Surface - Deposition(1 week)
- Horizontal Centration(1 Week)
- Visual Acuity(Baseline and 1 week)
- Lens Movement(1 Week)
- Horizontal Centration(Baseline)
- Vertical Centration(Baseline)
- Lens Movement(Baseline)
- Lens Surface - Deposition(Baseline)
- Lens Surface - Debris(Baseline)
- Lens Surface - Wettability(Baseline)