Effect of Olixia Pure® Eye Drops on Tear Film Thickness in Healthy Subjects
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Tear film thickness
研究概览
简要总结
Dry eye syndrome (DES) is a common ocular disease, especially in the elderly population. Despite many treatment approaches, instillation of topical lubricants remains the mainstay of therapy. However, most of the topical lubricants available are not very well characterized and data about efficacy is sparse.
The aim of the present project is to investigate the effect of topically administered Olixia pure® eye drops on tear film thickness in healthy subjects.
Tear film thickness will be determined using ultra high-resolution optical coherence tomography (OCT). Measurements will be performed before instillation of the eye drops and every 10 minutes after instillation for one hour. One eye will receive Olixia pure® eye drops, the fellow eye will receive physiologic saline solution as placebo control. The study eye will be chosen randomly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, 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 unless the investigator considers an abnormality to be clinically irrelevant
- •Normal ophthalmic findings, ametropia < 6 Dpt.
- •Schirmer I test > 10 mm and BUT > 10 sec
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
- •Ametropia =/> 6 Dpt
- •Pregnancy
- •Difference of more than 5 mm in Schirmer I test or difference of > 3 sec in BUT between the two eyes
- •Known medical history of allergy, hypersensitivity or poor tolerance to any components of the medication or medical product used in the study
结局指标
主要结局
Tear film thickness
时间窗: up to one hour
次要结局
未报告次要终点
研究者
Gerhard Garhofer
Assoc. Prof. PD Dr.
Medical University of Vienna