Comparison of a New AMO MPS to Existing Contact Lens Regimens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Corneal Staining
研究概览
简要总结
Crossover clinical evaluation three contact lens care regimens used for one month with Acuvue Oasys lenses.
详细描述
This is a three-arm crossover clinical evaluation of 40 subjects who will use each of three contact lens care regimens for one month with Acuvue Oasys lenses. The subjects will be randomized on the order of solutions used: Investigational MPS, ClearCare, and Opti-Free RepleniSH MPS.
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 (Investigator)
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is at least 17 years of age and has full legal capacity to volunteer;
- •Has read and signed an information consent letter;
- •Is willing and able to follow instructions and maintain the appointment schedule;
- •Has had an ocular examination in the last two years;
- •Is a current soft lens wearer using either two-week or monthly replacement lenses;
- •Is correctable to a visual acuity of 6/7.5 (20/25) or better (both eyes) with their habitual vision correction (either spectacles or contact lenses);
- •Has normal binocular vision (no strabismus, no amblyopia);
- •Has clear corneas and no active ocular disease;
- •Has a distance contact lens prescription between +8.00 diopters (D) to -12.00 D and a successful fit with the study lenses;
- •Has astigmatism less than or equal to -1.00 D;
- •Agrees to wear the study lenses on a daily wear basis.
排除标准
- •Has any active ocular disease;
- •Has any clinically significant lid, conjunctival, or corneal abnormalities that may affect a study outcome variable;
- •Has undergone corneal refractive surgery;
- •Has a systemic condition that may affect a study outcome variable;
- •Is using any systemic or topical medications that may affect ocular health;
- •Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
- •Is pregnant or lactating;
- •Is participating in any other clinical or research study that may affect a study outcome variable;
- •Currently wears daily disposable lenses or extended wear lenses.
研究组 & 干预措施
Investigational MPS
AMO Investigational MPS.
干预措施: Multi-purpose disinfecting solution (Device)
Clear Care
Peroxide-based lens care regimen.
干预措施: Clear Care (Device)
Opti-Free RepleniSH
Multi-purpose disinfecting solution (Alcon).
干预措施: Opti-Free RepleniSH (Device)
结局指标
主要结局
Corneal Staining
时间窗: 4 weeks
Corneal staining will be assessed with sodium fluorescein dye on the ocular surface. The cornea is split into 5 sections, each section is evaluated by staining type, depth, and extent is graded on a 0 to 100 scale with higher scores indicating more staining. The possible total range for the total score per eye is 0 to 50,000 (100x100x100=10,000 per section) with values higher than 1200 being clinically relevant.
次要结局
- Subjective Lens Wearing Comfort(4 weeks)
- Dryness(4 weeks)