Multi-Center 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
- 90
- 试验地点
- 5
- 主要终点
- Comfort
研究概览
简要总结
The purpose of this study is to compare the subjective performance of comfilcon A lens against samfilcon A lens after 4 weeks of reusable lens wear.
详细描述
This will be a 90 subject, randomized, bilateral, subject-masked, dispensing, cross-over study comparing comfilcon A versus samfilcon A lenses over 8 weeks of daily wear (2 x 4-weeks). Both eyes will wear the same lens (test or control) for 4 weeks in a randomized fashion. Subjects will be masked to lens type and investigators will be masked to the lens codes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spherical distance Contact Lens prescription between -1.00 and -6.00D or +1.00 to +4.00D in both eyes (inclusive)
- •Adapted soft Contact Lens wearers (i.e. >1 month), daily disposable and reusable lens wearers.
- •Spectacle cylinder 0.75D in both eyes.
- •Correctable to 6/9 (20/30) in both eyes
- •Be between 18 and 50 years of age (inclusive)
- •Able to read, comprehend and sign an informed consent
- •Own a mobile phone and be willing to respond to Short Message Service (SMS) survey
- •Willing to comply with the wear and study visit schedule
排除标准
- •Existing Biofinity or Ultra wearers
- •Any active corneal infection, injury or inflammation
- •Systemic or ocular allergies, which might interfere with Contact Lens wear
- •Systemic disease, which might interfere with Contact Lens wear
- •Ocular disease, which might interfere with Contact Lens wear
- •Strabismus or amblyopia
- •Subjects who have undergone corneal refractive surgery
- •Subjects with keratoconus or other severe corneal irregularity contraindicating lens wear
- •Pregnant or lactating
- •Use of systemic/topical medication contraindicating Contact Lens wear
- •Site employees or family members of site employees
研究组 & 干预措施
comfilcon A
Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.
干预措施: comfilcon A (Device)
samfilcon A
Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
干预措施: samfilcon A (Device)
结局指标
主要结局
Comfort
时间窗: Baseline, 2 weeks, 4 weeks
Subjective ratings of comfort (comfort after insertion, typical comfort just prior to removal, and overall comfort) for comfilcon A and samfilcon A assessed at baseline, 2 weeks, and 4 weeks. Scale of 0-10 (0=painful, 10=can't feel the lenses).
次要结局
- Lens Tightness Push-up(Baseline, 2 weeks, 4 weeks)
- Dryness(Baseline, 2 weeks, 4 weeks)
- Wearing Times(Baseline, 2 weeks, 4 weeks)
- Biomicroscopy Scores(Baseline, 2 weeks, 4 weeks)
- Deterioration in Comfort(Baseline, 2 weeks, 4 weeks)
- Overall Lens Handling(Baseline, 2 weeks, 4 weeks)
- Film Deposits(2 weeks and 4 weeks)
- Comfortable Wearing Time Via SMS (Short Message Service)(Days 3, 12, 26)
- Vision Quality(Baseline, 2 weeks, 4 weeks)
- Visual Acuity (VA)(Baseline, 2 weeks, 4 weeks)
- Lens Centration(Baseline, 2 weeks, 4 weeks)
- Corneal Coverage(Baseline Visit, 2 weeks follow-up, 4-weeks follow-up)
- Post-Blink Movement(Baseline, 2 weeks, 4 weeks)
- Lens Surface Wetting(Baseline, 2 weeks, 4 weeks)
- White Spot Deposits(2 weeks and 4 weeks)
- Primary Gaze Lag(Baseline, 2 weeks, and 4 weeks)
- Overall Fit Acceptance(Baseline, 2 weeks, 4 weeks)