NCT03519919已完成不适用
Clariti 1-Day Multifocal Study - 'Real World' Subjective Acceptance Study (HARP)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Vision Clarity During the Day - Distance Vision
研究概览
简要总结
The objective of the study is to evaluate the performance of somofilcon A 1 day multifocal when worn on a daily disposable wear modality over a period of up to 3 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is at least 17 years of age and has full legal capacity to volunteer;
- •Has read and signed an information consent letter;
- •Is willing and able to follow instructions and maintain the appointment schedule;
- •Has had a self-reported oculo-visual examination in the last two years.
- •Currently wears multifocal soft contact lenses, and have worn multifocal contact lenses for at least one month;
- •Presently wears lenses for minimum wear 4 days/week and 10 hours/day
- •Participant has an anticipated ability to wear test lenses for minimum 5 days/week and 10 hours/day.
- •Can be fit with the available test contact lens power range to achieve satisfactory vision i.e. 0.18 logMar (20/30) binocular distance acuity with the test lenses.
- •Current refraction indicates a reading addition of +1.50 or higher
- •Uses a digital device (computer/laptop/tablet etc.) for at least 5hrs/day
- •Spends 10 hrs or more indoors at least 5 days/week
- •Possesses a smartphone and is willing to download the MetricWire app to receive
排除标准
- •Is presently wearing Clariti 1 day multifocal lenses
- •Has astigmatism greater than -0.75 DCyl as determined with subjective refraction
- •Is participating in any concurrent clinical or research study;
- •Has any known active* ocular disease and/or infection;
- •Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- •Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
- •Has known sensitivity to fluorescein dye or products to be used in the study;
- •Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
- •Is aphakic;
- •Has undergone refractive error surgery;
- •Is an employee of the Centre for Contact Lens Research
研究组 & 干预措施
Somofilcon A multifocal lens
Experimental
Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment.
干预措施: somofilcon A multifocal lens (Device)
结局指标
主要结局
Vision Clarity During the Day - Distance Vision
时间窗: 3 weeks
Subjective expectation - Vision clarity during the day - distance vision was measured from three subjective expectation responses completed at the office. The responses were assigned numbers as below: Fell short of expectations = 1 Met my expectations = 2 Exceeded my expectations = 3
Vision Clarity During the Day - Distance Vision
时间窗: Baseline
Subjective expectation -Vision clarity during the day - distance vision was measured from three subjective expectation responses completed at the office. The responses were assigned numbers as below: Fell short of expectations = 1 Met my expectations = 2 Exceeded my expectations = 3
次要结局
- Visual Acuity(3 weeks)
- Ease of Insertion(3 weeks)
- Ease of Removal(3 weeks)
- Overall Satisfaction Preference Between Study and Habitual Contact Lenses(3 weeks)
- Corneal Staining(3 weeks)
- Conjunctival Staining(3 weeks)
- Subjective Vision Satisfaction - Near Vision(3 weeks)
- Overall Satisfaction With Speed of Changing Focus(3 weeks)
- Overall Preference Between Study and Habitual Contact Lenses for Lifestyle(3 weeks)
- Post-blink Lens Movement(3 weeks)
- Bulbar Hyperemia(3 weeks)
- Subjective Vision Satisfaction - Long Intermediate Vision(3 weeks)
- Overall Comfort(3 weeks)
- Number of Participants With Lens Centration(3 weeks)
- Subjective Vision Satisfaction - Driving at Night(3 weeks)
- Subjective Vision Satisfaction - Short Intermediate Tasks(3 weeks)
- Number of Participants With Lens Centration(Baseline)
- Visual Acuity(Baseline)
- Post-blink Lens Movement(Baseline)
- Corneal Staining(Baseline)
- Conjunctival Staining(Baseline)
- Bulbar Hyperemia(Baseline)
- Subjective Vision Satisfaction - Driving at Night(Baseline)
- Subjective Vision Satisfaction - Long Intermediate Vision(Baseline)
- Subjective Vision Satisfaction - Short Intermediate Tasks(Baseline)
- Subjective Vision Satisfaction - Near Vision(Baseline)
- Ease of Insertion(Baseline)
- Ease of Removal(Baseline)
- Overall Satisfaction With Speed of Changing Focus(Baseline)
- Overall Satisfaction Preference Between Study and Habitual Contact Lenses(Baseline)
研究者
研究点 (1)
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