BIOCLEAN MPS (Multi-Purpose Solution) VII in Combination With Biofinity Lens: A Two Week Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 3
- 主要终点
- Ocular Health - Corneal Staining
研究概览
简要总结
Two week, Open Label, randomized, bilateral, crossover, 1 week of daily wear in each combination (lens / disinfecting cleaning system).
详细描述
To determine if patients are unreactive to the lens care solution / Biofinity combination. It is expected that there will be a total of three visits: V1 (Initial), V2 (1 week), & V3 (2 weeks).
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
- None
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
- •Is over 18 years of age (inclusive)
- •Has had a self-reported visual exam in the last two years
- •Has a CL (contact lens) spherical prescription between -0.25D (Diopters) and -12.00D (inclusive)
- •Has less than 1.00 D spectacle cylinder in each eye
- •Is correctable to a visual acuity of 20/20 or better in both eyes
- •Has clear corneas and no active ocular disease
- •Has read, understood and signed the informed consent letter
- •Is willing to comply with the wear schedule (at least 40hrs per week)
- •Is willing to comply with the visit schedule
排除标准
- •Has never worn contact lenses before
- •Currently wears rigid gas permeable contact lens
- •Has a history of not achieving comfortable CL (contact lens) wear (5 days per week; > 8 hours per day)
- •Has a CL prescription outside the range of -0.25D to -12.00D
- •Has a spectacle cylinder greater than -0.75D of cylinder in either eye
- •Has best corrected spectacle distant vision worse than 20/20 in ether eye
- •Has any systemic disease affecting ocular health
- •Is using any systemic or topical medications that will affect ocular health
- •Has any ocular pathology or sever insufficiency of lacrimal secretion
- •Has persistent, clinically significant corneal or conjunctival staining
- •Has active neovascularization or any central corneal scars
- •Is aphakic
- •Is pregnant or lactating
研究组 & 干预措施
Bioclean MPS VII / comfilcon A combination
Participants were randomized to the Bioclean MPS VII / comfilcon A combination for one week during the cross over study.
干预措施: Bioclean MPS VII (Device)
Bioclean MPS VII / comfilcon A combination
Participants were randomized to the Bioclean MPS VII / comfilcon A combination for one week during the cross over study.
干预措施: comfilcon A (Device)
Aosept Clearcare / comfilcon A combination
Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week during the cross over study.
干预措施: Aosept Clearcare (Device)
Aosept Clearcare / comfilcon A combination
Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week during the cross over study.
干预措施: comfilcon A (Device)
结局指标
主要结局
Ocular Health - Corneal Staining
时间窗: 1 week
Corneal staining for Bioclean MPS (Multi-Purpose Solution) VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination assessed by slit lamp. Grade 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe.
次要结局
- Comfort(1 week)
- Dryness(1 week)
- Stinging and Burning Sensation(Baseline)