NCT00680108已完成2 期
A Double-Masked, Randomized, Placebo-Controlled, Rising-Dose Study of Multiple Ocular Instillations of INS365 Ophthalmic Solution in Patients With Mild to Moderate Dry Eye Disease.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 62
- 主要终点
- Evaluation of adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of INS365 Ophthalmic Solution when applied topically as eyedrops in patients with mild to moderate dry eye disease.
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
- Double
入排标准
- 接受健康志愿者
- 否
入选标准
- •Best corrected visual acuity 20/40 in each eye
- •2 out 5 specified symptoms
- •Corneal fluorescein staining score greater than or equal to 3 out of 15
排除标准
- •Unable to stop concomitant medications
- •Have had intraocular surgery in previous 90 days
- •Have excluded systemic or ocular disease
- •Wear contact lenses and are not willing to remove them
- •Have intraocular pressure greater than 22 mg Hg
结局指标
主要结局
Evaluation of adverse events
Ocular symptomatology
Visual acuity
Biomicroscopy
Ophthalmoscopy
次要结局
- Unanesthetized Schirmer test
研究者
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