NCT00679718已完成2 期
A Multi-Center, Double-Masked, Randomized, Placebo-Controlled, Dose-Ranging Study of Multiple Ocular Instillations of INS365 Ophthalmic Solution vs. Placebo in Patients With Moderate to Severe 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
- 150
- 主要终点
- Change in artificial tear usage
研究概览
简要总结
To evaluate the efficacy and safety of INS365 Ophthalmic Solution when applied topically in patients with moderate to severe 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 of at least +0.7 ETDRS
- •Six month history of dry eye disease
- •Mild severity in two out of five symptoms
- •Unanesthetized Schirmer score of less than or equal to 7mm
- •Corneal fluorescein staining greater than or equal to 4 out of 15 or lissamine green conjunctival staining of greater than or equal to 5 out of 18
排除标准
- •Nasal stimulated Schirmer score of less than 3mm
- •Have ongoing ocular infection
- •Have congenitally absent meibomian or lacrimal glands
- •Have had punctal occlusion within a specified time prior to study
- •Wear contact lens and refuse to remove them
- •Have other excluded eye conditions.
结局指标
主要结局
Change in artificial tear usage
Schirmer scores
Corneal staining
Conjunctival staining
Tear break-up time
Patient-reported improvement of foreign body sensation
次要结局
- Visual acuity
- Investigator global severity assessment
- Patient-reported dry eye symptoms other than foreign body sensation
- Biomicroscopy
- Ophthalmoscopy
- IOP
研究者
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