The Effects of Contact Lenses With Experimental Dye on Visual Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Two-Point Light Spread Function
研究概览
简要总结
This is a single-site, two-visit, contralateral, non-dispensing, randomized, controlled and subject-masked study to measure potential benefits of the new UV blocker.
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 65 Years（Adult, Older 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 18 and 65 (inclusive) years of age at the time of screening.
- •Be a current spherical soft silicone hydrogel contact lens wearer in both eyes with a minimum of 6 hours/day and 5 days/week wear time over the last 30 days by self-report.
- •The subject's vertex-corrected spherical equivalent distance refraction must be in the range of -1.00 through -4.50 D in each eye.
- •The subject has a best corrected visual acuity of 20/25 or better in each eye.
排除标准
- •Currently pregnant or breastfeeding.
- •Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
- •Any autoimmune disease or use of medication, which may interfere with contact lens wear. Habitual medications used by successful soft contact lens wearers are considered acceptable.
- •Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.
- •Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
- •Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- •Multifocal, toric or extended wear contact lens correction.
- •Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
- •History of binocular vision abnormality or strabismus.
- •Any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive diseases (e.g., HIV) by self-report.
- •Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
- •Any ocular infection.
- •Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification 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 may contraindicate contact lens wear.
研究组 & 干预措施
Test/Control
For Visit 1, subjects will be randomly assigned to 1 of 2 contralateral lens sequences (Right: Test, Left: Control) OR (Right: Control, Left: Test). Then for visit 2, subjects will be randomly assigned to the same 1 of 2 contralateral lens sequences again.
干预措施: senofilcon A with new UV blocker (Device)
Test/Control
For Visit 1, subjects will be randomly assigned to 1 of 2 contralateral lens sequences (Right: Test, Left: Control) OR (Right: Control, Left: Test). Then for visit 2, subjects will be randomly assigned to the same 1 of 2 contralateral lens sequences again.
干预措施: senofilcon A (Device)
Control/Test
For Visit 1, subjects will be randomly assigned to 1 of 2 contralateral lens sequences (Right: Test, Left: Control) OR (Right: Control, Left: Test). Then for visit 2, subjects will be randomly assigned to the same 1 of 2 contralateral lens sequences again.
干预措施: senofilcon A with new UV blocker (Device)
Control/Test
For Visit 1, subjects will be randomly assigned to 1 of 2 contralateral lens sequences (Right: Test, Left: Control) OR (Right: Control, Left: Test). Then for visit 2, subjects will be randomly assigned to the same 1 of 2 contralateral lens sequences again.
干预措施: senofilcon A (Device)
结局指标
主要结局
Two-Point Light Spread Function
时间窗: Between 5 minutes and 3 hours Post Lens Insertion, at Visit 2
The two-point light spread function was assessed at visit 2 for each subject eye under two conditions with a distance filter and without a distance filter. Measurements for this metric were taken twice, with the presence of an additional UV/HEV light source and without this additional light source (the same study lenses were used for both measurements). Two-point light spread function is defined that the as the minimum distance (mm) that two points of light are completely distinct. Measurements for this metric are positive. Smaller distances indicate better lens performance. The average distance for each lens type and light source combination was reported across age groups.
Halos
时间窗: Between 5 minutes and 3 hours Post Lens Insertion, at Visit 2
The appearance of Halos was assessed at visit 2 for each subject eye. Measurements for this metric were taken twice, with the presence of an additional UV/HEV light source and without this additional light source (the same study lenses were used for both measurements). Halos were quantified as the diameter (mm) of the outer edges of the Halo. Measurements for this metric are positive. Smaller diameter indicates better lens performance. The average diameter (mm) for each lens type and light source combination was reported across age groups.
Starburts
时间窗: Between 5 minutes and 3 hours Post Lens Insertion, at Visit 2
The appearance of starbursts was assessed at visit 2 for each subject eye. Measurements for this metric were taken twice, with the presence of an additional UV/HEV light source and without this additional light source (the same study lenses were used for both measurements). Starbursts are defined as the diameter (mm) of the light's lateral spread. Measurements for this metric are positive. Smaller diameter indicates better lens performance. The average diameter (mm) for each lens type and light source combination was reported across age groups.
次要结局
- Glare Disability Threshold(Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1)
- Photostress Recovery Time(Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1)
- Glare Discomfort(Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1)
- Heterochromatic Contrast Threshold(Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1)