Assessment of Contact Lens Wettability Using Wavefront Aberrometry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Higher Order Root Mean Square (HO RMS) - Distance Target in Primary Gaze With Controlled Blink
研究概览
简要总结
This study will test the feasibility that differences in contact lens wettability can be measured with a wavefront sensor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males or females that are at least 18 to no more than 40 years of age.
- •The subject must read, understand, and sign the Statement of Informed Consent and receive a fully executed copy of the form.
- •The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- •The subject must possess a wearable pair of spectacles with distance vision correction which provide satisfactory vision.
- •The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of lens wear per week for a minimum of 1 month prior to the study) or has sufficient prior experience with soft contact lens wear (defined as a minimum of 30 days of lens wear during the last 5 years).
- •The subject's vertexed best sphere distance refraction must be between -0.75 and -5.00 D in both eyes.
- •Cylinder refraction less than or equal to -0.75 D in both eyes (any axis).
- •The subject must have corrected visual acuity of 20/20 or better in each eye.
排除标准
- •Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
- •Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
- •Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
- •Any known hypersensitivity or allergic reaction to contact lens solutions or sodium fluorescein dye.
- •Any previous ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.)
- •Current wearers of rigid or hybrid contact lenses.
- •Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry.
- •Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
- •History of binocular vision abnormality or strabismus.
- •Employee of the investigational clinic (e.g. Investigator, Coordinator, Technician).
- •Clinically significant (grade 3 or 4) corneal edema, pterygium, corneal vascularization, corneal staining, or any other abnormalities of the cornea or conjunctiva which may interfere with the study measurements.
- •Strabismus, suppression or amblyopia.
- •Any ocular infection.
研究组 & 干预措施
senofilcon A
The lenses will be worn for 2 hours in both eyes, and not dispensed
干预措施: senofilcon A (Device)
senofilcon A
The lenses will be worn for 2 hours in both eyes, and not dispensed
干预措施: lotrafilcon B (Device)
lotrafilcon A
The lenses will be worn for 2 hours in both eyes, and not dispensed
干预措施: senofilcon A (Device)
lotrafilcon A
The lenses will be worn for 2 hours in both eyes, and not dispensed
干预措施: lotrafilcon B (Device)
结局指标
主要结局
Higher Order Root Mean Square (HO RMS) - Distance Target in Primary Gaze With Controlled Blink
时间窗: 2 hours post insertion
Wavefront metric measured by COAS wavefront sensor while subject fixates a distant target in primary gaze with controlled blinking. The average HO RMS was reported for each lens. Lower values indicate better outcome.
Higher Order Root Mean Square (HO RMS) - Near Target in Downgaze With Controlled Blink
时间窗: 2 hours post insertion
Wavefront metric measured by COAS wavefront sensor while subject fixates a near digital device in a down-gaze position with controlled blinking. The average HO RMS was reported for each lens. Lower values indicate better outcome.
Higher Order Root Mean Square (HO RMS) - Near Target in Downgaze With Natural Blinking
时间窗: 2 hours post insertion
Wavefront metric measured by COAS wavefront sensor while subject fixates a near digital device in a down-gaze position with natural blinking. The average HO RMS was reported for each lens. Lower values indicate better outcome.
次要结局
未报告次要终点