临床试验/NCT01087671

NCT01087671已完成3 期

Ocular Signs and Symptoms in Patients With Ocular Hypertension or Open-angle Glaucoma Switched From Preserved Latanoprost 0.005% Eye Drops to Preservative Free Tafluprost Eye Drops

Santen Oy0 个研究点目标入组 185 人开始时间: 2010年4月最近更新: 2013年5月31日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: Santen Oy
入组人数: 185
主要终点: Assessment of changes in ocular symptoms and signs

研究概览研究设计入排标准研究组 & 干预措施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 investigate if changes in ocular signs and symptoms occur in patients with ocular hypertension or glaucoma when they switch from latanoprost 0.005% (Xalatan) to preservative free Tafluprost eye drops.

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 with a diagnosis of ocular hypertension or open angle glaucoma for which the patient has been using latanoprost 0.005% as his/her prior medication.
•Evaluable patients must have ocular surface related symptoms and/or signs with their prior medication.

排除标准

未提供

研究组 & 干预措施

Open-lable study with one arm

Other

干预措施: tafluprost (Drug)

结局指标

主要结局

Assessment of changes in ocular symptoms and signs

时间窗: From Screening (Visit 1) to12 weeks.

Ocular symptoms include: irritation/burning/stinging, foreign body sensation, tearing, itching and dry eye sensation. Following signs will be evaluated: tear break-up time, corneal and conjunctival fluorescein staining, blepharitis, conjunctival redness and tear secretion (schirmer test).

次要结局

Secondary outcome measures include the assessment of safety and quality of life parameters.(From Screening (visit 1) to 12 weeks)

研究者

发起方

Santen Oy

申办方类型

Industry

责任方

Sponsor

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