Evaluating the Impact of JJVC Senofilcon A - Based Contact Lens With New UV-blocker on Day and Night Driving Performance
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Overall Nighttime Driving Score
研究概览
简要总结
This is a bilateral, non-dispensing, randomized, subject masked, four visits, 3-period by 3- treatment crossover study. The objective of this study is to evaluate the effect of JJVC senofilcon A - based contact lens with new UV-blocker on vision and driving performance in both daytime and nighttime lighting under real world driving conditions. This will be achieved through field-based driving studies on a closed-road driving circuit at night and during the day. Quantitative methods will be used to assess vision and driving performance under a range of challenging conditions and appropriate masking, order of testing, randomization and control conditions will be used.
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
- 20 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Potential subjects must satisfy all of the following criteria to be enrolled in the study:
- •The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- •Appear able and willing to adhere to the instructions set forth in this clinical protocol.
- •Between 20 and 49 (inclusive) years of age at the time of screening.
- •Presbyopic subjects must be habitual wearers of distance vision correction in both eyes.
- •The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 through -6.00 D (inclusive) in each eye.
- •The subject's refractive cylinder must be ≤ 1.00 D in each eye.
- •Have spherocylindrical best corrected visual acuity of 20/20 or better in each eye.
- •Be a current soft contact lens wearer in both eyes, defined as at least 5 days per week and 6 hours per day averaged over the past 30 days.
- •Hold a current Open driver's license
- •Be a regular driver (at least once per week)
- •Have at least one year of driving experience
排除标准
- •Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- •Currently pregnant or lactating
- •Any systemic disease (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study.
- •Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear, pupil size or accommodation.
- •Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion.
- •History of binocular vision abnormality or strabismus
- •Any current use of ocular medication
- •Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.)
- •Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA slit lamp biomicroscopy scale
- •Any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that would contraindicate contact lens wear
- •Employee of clinical site (e.g., Investigator, Coordinator, Technician)
研究组 & 干预措施
Test/Control 1/Control 2
Subjects will be randomized to 1 of 3 lenses (Test/Control 1/Control 2). Subjects will also be randomized to (1) Sequence of driving time (Day and Night) and (2) Driving Route (A, B, C). Hazard and pedestrian locations will be randomized for each driving route.
干预措施: Investigational Contact Lens (Device)
Test/Control 1/Control 2
Subjects will be randomized to 1 of 3 lenses (Test/Control 1/Control 2). Subjects will also be randomized to (1) Sequence of driving time (Day and Night) and (2) Driving Route (A, B, C). Hazard and pedestrian locations will be randomized for each driving route.
干预措施: Commercial ACUVUE OASYS (Device)
Test/Control 1/Control 2
Subjects will be randomized to 1 of 3 lenses (Test/Control 1/Control 2). Subjects will also be randomized to (1) Sequence of driving time (Day and Night) and (2) Driving Route (A, B, C). Hazard and pedestrian locations will be randomized for each driving route.
干预措施: Commercial ACUVUE OASYS and Spectacles (Device)
Test/Control 2/Control 1
Subjects will be randomized to 1 of 3 lenses (Test/Control 2/Control 1). Subjects will also be randomized to (1) Sequence of driving time (Day and Night) and (2) Driving Route (A, B, C). Hazard and pedestrian locations will be randomized for each driving route.
干预措施: Investigational Contact Lens (Device)
Test/Control 2/Control 1
Subjects will be randomized to 1 of 3 lenses (Test/Control 2/Control 1). Subjects will also be randomized to (1) Sequence of driving time (Day and Night) and (2) Driving Route (A, B, C). Hazard and pedestrian locations will be randomized for each driving route.
干预措施: Commercial ACUVUE OASYS (Device)
Test/Control 2/Control 1
Subjects will be randomized to 1 of 3 lenses (Test/Control 2/Control 1). Subjects will also be randomized to (1) Sequence of driving time (Day and Night) and (2) Driving Route (A, B, C). Hazard and pedestrian locations will be randomized for each driving route.
干预措施: Commercial ACUVUE OASYS and Spectacles (Device)
Control 1/Test/Control 2
Subjects will be randomized to 1 of 3 lenses (Control 1/Test/Control 2). Subjects will also be randomized to (1) Sequence of driving time (Day and Night) and (2) Driving Route (A, B, C). Hazard and pedestrian locations will be randomized for each driving route.
干预措施: Investigational Contact Lens (Device)
Control 1/Test/Control 2
Subjects will be randomized to 1 of 3 lenses (Control 1/Test/Control 2). Subjects will also be randomized to (1) Sequence of driving time (Day and Night) and (2) Driving Route (A, B, C). Hazard and pedestrian locations will be randomized for each driving route.
干预措施: Commercial ACUVUE OASYS (Device)
Control 1/Test/Control 2
Subjects will be randomized to 1 of 3 lenses (Control 1/Test/Control 2). Subjects will also be randomized to (1) Sequence of driving time (Day and Night) and (2) Driving Route (A, B, C). Hazard and pedestrian locations will be randomized for each driving route.
干预措施: Commercial ACUVUE OASYS and Spectacles (Device)
Control 1/Control 2/Test
Subjects will be randomized to 1 of 3 lenses (Control 1/Control 2/Test). Subjects will also be randomized to (1) Sequence of driving time (Day and Night) and (2) Driving Route (A, B, C). Hazard and pedestrian locations will be randomized for each driving route.
干预措施: Investigational Contact Lens (Device)
Control 1/Control 2/Test
Subjects will be randomized to 1 of 3 lenses (Control 1/Control 2/Test). Subjects will also be randomized to (1) Sequence of driving time (Day and Night) and (2) Driving Route (A, B, C). Hazard and pedestrian locations will be randomized for each driving route.
干预措施: Commercial ACUVUE OASYS (Device)
Control 1/Control 2/Test
Subjects will be randomized to 1 of 3 lenses (Control 1/Control 2/Test). Subjects will also be randomized to (1) Sequence of driving time (Day and Night) and (2) Driving Route (A, B, C). Hazard and pedestrian locations will be randomized for each driving route.
干预措施: Commercial ACUVUE OASYS and Spectacles (Device)
Control 2/Test/Control 1
Subjects will be randomized to 1 of 3 lenses (Control 2/Test/Control 1). Subjects will also be randomized to (1) Sequence of driving time (Day and Night) and (2) Driving Route (A, B, C). Hazard and pedestrian locations will be randomized for each driving route.
干预措施: Investigational Contact Lens (Device)
Control 2/Test/Control 1
Subjects will be randomized to 1 of 3 lenses (Control 2/Test/Control 1). Subjects will also be randomized to (1) Sequence of driving time (Day and Night) and (2) Driving Route (A, B, C). Hazard and pedestrian locations will be randomized for each driving route.
干预措施: Commercial ACUVUE OASYS (Device)
Control 2/Test/Control 1
Subjects will be randomized to 1 of 3 lenses (Control 2/Test/Control 1). Subjects will also be randomized to (1) Sequence of driving time (Day and Night) and (2) Driving Route (A, B, C). Hazard and pedestrian locations will be randomized for each driving route.
干预措施: Commercial ACUVUE OASYS and Spectacles (Device)
Control 2/Control 1/Test
Subjects will be randomized to 1 of 3 lenses (Control 2/Control 1/Test). Subjects will also be randomized to (1) Sequence of driving time (Day and Night) and (2) Driving Route (A, B, C). Hazard and pedestrian locations will be randomized for each driving route.
干预措施: Investigational Contact Lens (Device)
Control 2/Control 1/Test
Subjects will be randomized to 1 of 3 lenses (Control 2/Control 1/Test). Subjects will also be randomized to (1) Sequence of driving time (Day and Night) and (2) Driving Route (A, B, C). Hazard and pedestrian locations will be randomized for each driving route.
干预措施: Commercial ACUVUE OASYS (Device)
Control 2/Control 1/Test
Subjects will be randomized to 1 of 3 lenses (Control 2/Control 1/Test). Subjects will also be randomized to (1) Sequence of driving time (Day and Night) and (2) Driving Route (A, B, C). Hazard and pedestrian locations will be randomized for each driving route.
干预措施: Commercial ACUVUE OASYS and Spectacles (Device)
结局指标
主要结局
Overall Nighttime Driving Score
时间窗: 15 Minutes Post Lens Fitting
Overall driving performance score is a composite score calculated as the mean of the Z-scores of the following six driving measures: average sign recognition distance (in meters), percentage of correctly identified sign (\~42 signs), percentage of hazard avoidance/detection (9 hazards), average pedestrian recognition distance (in meters), lane keeping (percentage of time inside the lane) and the inverse of driving lap time (in seconds).). Equal weighting was assigned to each measure. The individual Z scores were transformed (inverted) such that positive Z scores relate to better performance than the mean. Z scores follow a standard normal distribution (ranging from minus infinity to positive infinity). Overall Z score for night time driving was reported for each study lens.
次要结局
- Binocular Visual Acuity(15 Minutes Post Lens Fitting)
- Binocular Contrast Threshold Without Glare(15 Minutes Post Lens Fitting)
- Percentage of Road Signs Correctly Identified During Night Driving(15 Minutes Post Lens Fitting)
- Average Distance to Correctly Identify Road Signs During Night Driving(15 Minutes Post Lens Fitting)
- Percentage of Hazards Avoided During Night Driving(15 Minutes Post Lens Fitting)
- Average Pedestrian Recognition Distance(15 Minutes Post Lens Fitting)