NCT00201955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, 26 Week Study
Otsuka Pharmaceutical Development & Commercialization, Inc.117 个研究点 分布在 1 个国家目标入组 762 人开始时间: 2004年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 762
- 试验地点
- 117
- 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 symptoms.
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
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
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
研究者
研究点 (117)
Loading locations...
相似试验
已完成
3 期
Study of Rebamipide Eye Drops to Treat Dry EyeKeratoconjunctivitis SiccaNCT00201981Otsuka Pharmaceutical Development & Commercialization, Inc.740
已完成
3 期
Efficacy and Safety of Rebamipide in Subjects With Dry Eye SyndromeDry Eye SyndromeNCT01632137Kubota Vision Inc.564
已完成
不适用
Evaluation of efficacy of rebamipide ophthalmic suspension in patients with dry eye associated with Sjogren's syndrome.JPRN-UMIN000008427Kanazawa Medical University30
已完成
3 期
Three Month Efficacy/Safety Study With a 3-Month Safety Extension of Brinzolamide 1%/Brimonidine 0.2% vs. Brinzolamide 1% or Brimonidine 0.2%Open-Angle GlaucomaOcular HypertensionNCT01297920Alcon Research1,062
已完成
不适用
Effect of rebamipide in soft contact lens patients with dry eyes.dry eyeJPRN-UMIN000019738ippon Medical School Hospital20