Assessing Patient Comfort in Silicone Hydrogel Contact Lenses When Cleaned and Stored in Two Different Multi-Purpose Disinfecting Solutions
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 54
- 试验地点
- 6
- 主要终点
- Self-reported comfort scores with contact lens care systems
研究概览
简要总结
Tolerability is compared between two Multi-purpose disinfecting solutions (MPDS).
详细描述
According to recent surveys of contact lens fitters, the most prescribed treatments for contact lens dryness are: more frequent replacement schedule (24%), refit into different material (23%), rewetting drops (21%) and change care system (15%). Changing care systems has been a standard treatment for CL discomfort for many years. In the same survey, 30% of practitioners felt there is absolutely no difference among solutions with respect to reducing dryness and discomfort.
The investigators set out to compare the clinical performance of these two solutions: AMO's RevitaLens and Alcon's Opti-Free PureMoist.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between the ages of 18 and over inclusive.
- •Males or females
- •Patient is in generally good & stable overall health.
- •Patient likely to comply with study guidelines & study visits.
- •Informed consent signed.
- •Are willing/able to return for all required study visits.
- •Are willing/able to follow instructions from the study investigator and his/her staff.
- •Have signed informed consent approved by Institutional Review Board or Independent Ethics Committee.
排除标准
- •Corneal refractive surgery within 6 months of this study.
- •Intra-ocular surgery within 6 months or ocular laser surgery within 6 months.
- •Ocular pathology (includes glaucoma and cataract), which could impact results and/or place patient at risk.
结局指标
主要结局
Self-reported comfort scores with contact lens care systems
时间窗: 14 days
Comfort measured by questionnaires covering positive and negative attributes of contact lens wear
次要结局
未报告次要终点
研究者
Milton M. Hom, OD, FAAO.
Optometrist
Hom, Milton M., OD, FAAO