Effect of Topical Glaucoma Therapy on Tear Film Stability in Healthy Subjects
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Tear film thickness
研究概览
简要总结
Long term treatment with anti-glaucomatous drugs has been shown to increase the incidence of dry eye syndrome with all known consequences such as ocular discomfort and epithelial keratitis. Given that thinning of the tear film appears to be a risk factor for the development or the aggravation of dry eye syndrome, the current study seeks to investigate whether tear film thickness is changed after topical treatment with anti-glaucomatous drugs in healthy subjects.
For this purpose, tear film thickness will be measured at baseline and after single instillation of one of 5 study drugs in one randomly chosen eye. In addition, one group of 20 subjects will receive no drug and will serve as a second control. Drug effects on tear film thickness will be compared to the fellow, non-treated eye. In addition, effects on tear film thickness of timolol with preservatives (Timoptic 0.5%) will be compared to timolol without preservatives (Timophtal sine 0.5%) and three lubricants with different viscosity (Genteal HA, Hylo-Comod, Thealoz).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged over 18 years
- •Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- •Normal ophthalmic findings, ametropia < 6 Dpt.
排除标准
- •Regular use of medication (except contraceptives), abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
- •Treatment in the previous 3 weeks with any drug
- •Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- •Patients with known hypersensitivity to the study drug or any ingredients
- •History or current COPD or asthma
- •AV-block grade II or more
- •Ametropy ≥ 6 Dpt
- •Pregnancy
研究组 & 干预措施
healthy subjects I
20 healthy subjects
干预措施: Timoptic® 0.5% (Drug)
healthy subjects II
20 healthy subjects
干预措施: Timophtal sine® 0.5% (Drug)
healthy subjects III
20 healthy subjects
干预措施: Genteal HA® (Device)
healthy subjects IV
20 healthy subjects
干预措施: Hylo-Comod® (Device)
healthy subjects V
20 healthy subjects
干预措施: Thealoz® (Device)
结局指标
主要结局
Tear film thickness
时间窗: up to 1 hour
次要结局
- Break up time (BUT)(once on the study day)
研究者
Gerhard Garhofer
Assoc. Prof. PD Dr.
Medical University of Vienna