The Clinical Comparison of the Clariti 1 Day and DAILIES AquaComfort PLUS Daily Disposable 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
- 2
- 主要终点
- Subjective Comfort at Lens Dispensing
研究概览
简要总结
This subject-masked, randomized, bilateral crossover study will compare the clinical performance and subjective acceptance of the somofilcon A 1 day soft contact lens with the nelfilcon A daily disposable 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. This will compare the clinical performance and subjective acceptance of the somofilcon A 1 day soft contact lens with the nelfilcon A daily disposable lens when used on a daily wear, daily disposable basis.
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
- Other
- 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
- 否
入选标准
- •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 maximum of -1.00DC ocular astigmatism in each eye.
- •They can be satisfactorily fitted with the study lens types.
- •At dispensing, they can attain at least 0.20 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).
- •They own a wearable pair of spectacles.
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 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 clariti 1day or the DAILIES AquaComfort Plus lens.
结局指标
主要结局
Subjective Comfort at Lens Dispensing
时间窗: Baseline (after 5 minutes of lens dispense)
Subjective comfort at lens dispensing on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).
Subjective Comfort at End of Day
时间窗: 1 week
Subjective comfort at end of day on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).
Overall Subjective Comfort
时间窗: 1 week
Overall subjective comfort on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).
Subjective Vision
时间窗: 1 week
Subjective Vision rated on scale 0-100 (0=unacceptable, lens cannot be worn to 100=excellent, unaware of an visual loss.)
Subjective Comfort at Start of Day
时间窗: 1 week
Subjective comfort at start of day on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).
次要结局
- Biomicroscopy - Corneal Staining Score(One week)
- Horizontal Centration - Lens Fit(One Week)
- Post-Blink Movement Grade(1 week)
- Ocular Redness Rating(1 week)
- Biomicroscopy - Papillary Conjunctivitis Score(One week)
- Vertical Centration Grade - Lens Fit(One week)
- Biomicroscopy - Conjunctival Redness Score(One Week)
- Biomicroscopy - Limbal Redness Score(One week)
- Biomicroscopy - Conjunctival Staining Score(One week)
- Corneal Coverage Grade(One week)