Multi-Centre Clinical Evaluation of Two Reusable Soft Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 9
- 主要终点
- Comfort During the Day
研究概览
简要总结
The aim of this study is to compare the subjective performance of the comfilcon A contact lens against lotrafilcon B contact lens after 4 weeks of reusable lens wear.
详细描述
This will be a 80 subject, randomized, bilateral, double-masked, dispensing, cross-over study comparing comfilcon A versus lotrafilcon B lenses over 4 weeks of daily wear for each lens pair.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 34 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Spherical distance CL (Contact Lens) prescription between -1.00 and -6.00D (Diopter) OR in both eyes (inclusive)
- •Adapted soft CL wearers (i.e. >1 month) who are reusable lens wearers*
- •Spectacle cylinder 0.75D in both eyes
- •Correctable to 6/9 in both eyes
- •Be between 18 and 34 years of age (inclusive)
- •Able to read, comprehend and sign an informed consent
- •Own a mobile phone and be able to respond to SMS survey during the period 8am - 8pm
- •Willing to comply with the wear and study visit schedule
排除标准
- •Any of the following will render a subject ineligible for inclusion:
- •Existing wearer of daily disposable contact lenses
- •Known allergy to Opti-Free PureMoist multipurpose solution
- •Any active corneal infection, injury or inflammation
- •Systemic or ocular allergies, which might interfere with CL wear
- •Systemic disease, which might interfere with CL wear
- •Ocular disease, which might interfere with CL wear
- •Strabismus or amblyopia
- •Subjects who have undergone corneal refractive surgery
- •Subjects with keratoconus or other severe corneal irregularity contraindicating lens wear
- •Pregnant, planning a pregnancy or lactating
- •Use of systemic/topical medication contraindicating CL wear
- •Site employees or family members of investigators
- •Participation in any concurrent trial or in the last 30 days
研究组 & 干预措施
lotrafilcon B
Participants wear lotrafilcon B lens for 4 weeks during the cross over study.
干预措施: lotrafilcon B (Device)
comfilcon A
Participants wear comfilcon A lens for 4 weeks during the cross over study.
干预措施: comfilcon A (Device)
结局指标
主要结局
Comfort During the Day
时间窗: Days 3, 12, 26
Comfort during the day for comfilcon A and lotrafilcon B lenses assessed via via SMS (short message service) text message at days 3,12, and 26 at hours 8:00 am, 12:00 pm, 4:00 pm, and 8:00 pm. Scale 0-10, 0=painful, 10=can't feel the lenses.
Comfort
时间窗: Baseline, 2 weeks, 4 weeks
Comfort (insertion, end of the day, and overall) for habitual lenses assessed at baseline and comfilcon A and lotrafilcon B lenses assessed at 2 weeks and 4 weeks. Scale 0-10, 0=painful, 10=can't feel the lenses.
次要结局
未报告次要终点