Comparison of Lens Care Regimens With a Silicone Hydrogel Lens (Emerald)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- High Contrast Visual Acuity
研究概览
简要总结
The purpose of the study is to evaluate and compare, on a daily wear basis, the performance of two contact lens care solutions when used with silicone hydrogel soft contact lenses with regards to comfort and dryness symptoms.
详细描述
The purpose of the study is to evaluate and compare, on a daily wear basis, the performance of two contact lens care solutions when used with silicone hydrogel soft contact lenses with regards to comfort and dryness symptoms by observing changes within the cornea and collecting subjective ratings
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
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A person is eligible for inclusion in the study if he/she:
- •Is at least 17 years of age and has full legal capacity to volunteer.
- •Has read, understood and signed an information consent letter.
- •Is willing and able to follow instructions and maintain the appointment schedule.
- •Is presently using either bi-weekly or monthly replacement lenses.
- •Has symptoms of ocular dryness as determined by specific pre-screening criteria.
- •Is correctable to a visual acuity of 6/9 or better (in each eye) with their habitual vision correction.
- •Has clear corneas and no active ocular disease.
- •Has had an ocular examination in the last two years.
排除标准
- •A person will be excluded from the study if he/she:
- •Is an asymptomatic lens wearer.
- •Is a daily disposable contact lens wearer.
- •Is a current extended wear contact lens wearer.
- •Currently uses one of the study lens care regimens.
- •Has any clinically significant blepharitis.
- •Has undergone corneal refractive surgery.
- •Is aphakic.
- •Has any active ocular disease.
- •Has any systemic disease affecting ocular health.
- •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 participating in any other type of clinical or research study.
研究组 & 干预措施
1
干预措施: ClearCare (Drug)
2
干预措施: Optifree Replenish (Drug)
结局指标
主要结局
High Contrast Visual Acuity
时间窗: 2 weeks
High Contrast Visual Acuity with contact lenses, was measured using standardized and computer generated logMAR chart. 10 Sloan letters adopted. VA chart's target size varied from logMAR 1.0 to -0.40 in 0.1 logMAR step.
Low Contrast Visual Acuity
时间窗: 2 weeks
Low Contrast Visual Acuity with contact lenses, was measured using standardized and computer generated logMAR chart. 10 Sloan letters adopted. VA chart's target size varied from logMAR 1.0 to -0.40 in 0.1 logMAR step.
In-vivo Wettability
时间窗: 2 weeks
Pre-lens non-invasive tear breakup time
Subjective Comfort Rating
时间窗: 2 weeks
Numeric rating scale was administered. Comfort ratings (0 - 100), 0 = Very poor comfort and 100 = Excellent comfort.
次要结局
未报告次要终点