NCT00201981已完成3 期
Rebamipide Ophthalmic Suspension in the Treatment of Dry Eye: A Multicenter, Phase 3, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, 52 Week Study
Otsuka Pharmaceutical Development & Commercialization, Inc.63 个研究点 分布在 1 个国家目标入组 740 人开始时间: 2004年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 740
- 试验地点
- 63
- 主要终点
- fluorescein corneal staining (FCS) total score at week 12 and the average primary ocular discomfort (POD) severity score at week 12
研究概览
简要总结
The purpose of this study is to determine the potential safety and effectiveness of rebamipide eye drops, an investigational eye drop being developed for the treatment of keratoconjunctivitis sicca (dry eye).
详细描述
There is a need for effective therapy for dry eye that treats the underlying cause of the syndrome. The goal of this study is to assess the impact of rebamipide on dry eye symptom.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, 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
- 否
入选标准
- •must have symptoms of dry eye for a minimum of 6 months
- •must be able to sign and date an informed consent
排除标准
- •presence of anterior segment disease
- •glaucoma or ocular hypertension
- •using Restasis
- •use of topically instilled ocular medications during study
- •use of contact lenses
- •history of ocular surgery within 12 months
- •females who are pregnant, breast feeding, or child-bearing potential and not willing to remain abstinent or use contraception
- •presence of Stevens-Johnson syndrome
- •any anticipated change in medication through-out study
- •concurrent involvement in another study or previous receipt of this drug
- •cannot be safely be weaned off of ocular medications
研究组 & 干预措施
1
Active Comparator
rebamipide 1%
干预措施: Rebamipide (Drug)
2
Active Comparator
Rebamipide 2%
干预措施: Rebamipide (Drug)
结局指标
主要结局
fluorescein corneal staining (FCS) total score at week 12 and the average primary ocular discomfort (POD) severity score at week 12
时间窗: 12 week and 26 week
次要结局
- fluorescein corneal staining (FCS) total score at week 26 and the average primary ocular discomfort (POD) severity score at week 26(12 week and 26 week)
研究者
研究点 (63)
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