AIR OPTIX® COLORS: Automated vs Semi-automated Manufacturing Processes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 主要终点
- Overall satisfaction
研究概览
简要总结
The purpose of this feasibility study was to compare AIR OPTIX® COLORS contact lenses manufactured using an automated process to AIR OPTIX® COLORS contact lenses manufactured using a semi-automatic process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Device Feasibility
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Able and willing to sign a written Informed Consent form.
- •Cylinder ≤ -0.75 diopter (D).
- •Able to achieve visual acuity (VA) of at least 20/30 Snellen in each eye at distance with contact lenses (CLCVA) and best corrected visual acuity (BCVA) ≥ 20/
- •Have spectacles that provide acceptable vision and be willing to wear them if unable to wear the study lenses.
- •Successful daily wear of single-vision spherical soft contact lenses in both eyes during the past 3 months for a minimum of 8 hours/day, 5 days/week.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Eye injury or surgery within twelve weeks immediately prior to enrollment in this trial.
- •Pre-existing ocular irritation that would preclude contact lens fitting.
- •Currently enrolled in an ophthalmic clinical trial.
- •Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of accessory solutions, as determined by the investigator.
- •Pathologically dry eye.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
AIR OPTIX® COLORS Auto, then AIR OPTIX® COLORS Semi-auto
Lotrafilcon B contact lens with color, automated, worn first, with Lotrafilcon B contact lens with color, semi-automated, worn second. Each product worn on a daily wear basis approximately 8 hours a day, 5 days a week, for 2 weeks.
干预措施: Lotrafilcon B contact lens with color, automated (Device)
AIR OPTIX® COLORS Auto, then AIR OPTIX® COLORS Semi-auto
Lotrafilcon B contact lens with color, automated, worn first, with Lotrafilcon B contact lens with color, semi-automated, worn second. Each product worn on a daily wear basis approximately 8 hours a day, 5 days a week, for 2 weeks.
干预措施: Lotrafilcon B contact lens with color, semi-automated (Device)
AIR OPTIX® COLORS Semi-auto, then AIR OPTIX® COLORS Auto
Lotrafilcon B contact lens with color, semi-automated, worn first, with Lotrafilcon B contact lens with color, automated, worn second. Each product worn on a daily wear basis approximately 8 hours a day, 5 days a week, for 2 weeks.
干预措施: Lotrafilcon B contact lens with color, automated (Device)
AIR OPTIX® COLORS Semi-auto, then AIR OPTIX® COLORS Auto
Lotrafilcon B contact lens with color, semi-automated, worn first, with Lotrafilcon B contact lens with color, automated, worn second. Each product worn on a daily wear basis approximately 8 hours a day, 5 days a week, for 2 weeks.
干预措施: Lotrafilcon B contact lens with color, semi-automated (Device)
结局指标
主要结局
Overall satisfaction
时间窗: Week 2
The participant was asked, "Please rate your overall satisfaction based on your experience with the study lenses over the last 2 weeks. When considering your rating, please take into account comfort, vision, and handling, but disregard the appearance of the lenses." Overall satisfaction was rated on a scale of 1-10, with 1=Not at all satisfied, and 10=Completely satisfied.
次要结局
- Contact Lens Corrected Visual Acuity (CLCVA)(Dispense (Day 0))
- Overall lens fit(Week 2)
- Corrected distance monocular visual measurement in normal illumination reported as Contact Lens Corrected Visual Acuity (CLCVA)(Week 2)
- Overall lens fit(Dispense (Day 0))