An Open-Label, Single-Center Study Evaluating the Effect of Systane Balance on Video Ocular Protection Index (OPI) and Blink Patterns in Patients Diagnosed With Dry Eye

Alcon Research0 个研究点目标入组 30 人开始时间: 2010年8月最近更新: 2012年4月10日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Alcon Research
入组人数: 30
主要终点: Changes in video Ocular Protection Index 10 and 55 minutes following Systane Balance instillation at Days 1 and 7.

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to evaluate the effect of acute and repeat dosing of Systane Balance on Video Ocular Protection Index (OPI) and Blink Patterns in a population of dry eye patients.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

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

•Patients must have history of mild-moderate dry eye with use of (or desire to use) eye drops in past 6 months

排除标准

•Patients cannot wear contact lenses within 1 week prior nor during the study, and cannot have a history of hypersensitivity to any component of Systane Balance.

结局指标

主要结局

Changes in video Ocular Protection Index 10 and 55 minutes following Systane Balance instillation at Days 1 and 7.

时间窗: 8 days

次要结局

Ocular Symptomology at each visit(9 days)
Fluorescein staining at Visits 1 & 3 on the Ora staining scale(9 days)
Changes in blink pattern in subjects with mean Interblink Interval (IBI) < 3 seconds at Days 2 and 8(9 days)

研究者

发起方

Alcon Research

申办方类型

Industry

责任方

Sponsor

相似试验

已完成

不适用

Clinical Outcomes Following Treatment With Systane® Balance in Dry Eye SubjectsDry Eye

NCT01967147Alcon Research279

已完成

1 期

An Open Label, Single-dose, Single Period ADME Study of A4250 in Healthy SubjectsOrphan Cholestatic Liver DiseasesAlagille SyndromePrimary Biliary CirrhosisProgressive Familial Intrahepatic Cholestasis

NCT03082937Albireo6

已完成

1 期

Mass Balance Study of [14C]-NT-814 Oral Suspension in Healthy Male SubjectsHealthy

NCT04654897Bayer6

已完成

1 期

Mass Balance Study of [14C]-Orvepitant Oral Solution in Healthy Male SubjectsHealthy

NCT04387981Nerre Therapeutics Ltd.6

已完成

1 期

Mass Balance Recovery, Absorption, Metabolism and Excretion of [14C]-BLU-5937Healthy

NCT05244759Bellus Health Inc. - a GSK company6