NCT00817557Unknown4 期
Use of Loteprednol for Contact Lens Intolerance and Dryness
Hom, Milton M., OD, FAAO1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2009年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Wearing time
研究概览
简要总结
Study of the effects of Loteprednol on CL dryness
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
- 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
- •Any race or ethnic background
- •CL history- experienced intolerance and either switched solutions or lenses without satisfactory relief.
- •Patient is in generally good & stable overall health.
- •Patient likely to comply with study guidelines & study visits.
- •Informed consent signed.
- •OSDI score 18 or higher while wearing lenses
- •Unsatisfactory wearing time with contact lenses
排除标准
- •Corneal refractive surgery within 6 months of this study.
- •Contact lens use on day of examination.
- •Corneal ectasia.
- •Current use of Restasis
- •Intra-ocular surgery within 6 months or ocular laser surgery within 6 months.
- •Pregnant or lactating women.
- •Ocular pathology (includes glaucoma and cataract) which could impact results and/or place patient at risk.
研究组 & 干预措施
Loteprednol
Active Comparator
Loteprednol BID
干预措施: Loteprednol (Drug)
Rewetter
Placebo Comparator
Rewetter BID
干预措施: Rewetter (Other)
结局指标
主要结局
Wearing time
时间窗: 28 days
次要结局
- OSDI(28 days)
研究者
研究点 (1)
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