Effect of Single Instillation of Four Different Diagnostic Eye Drops on Tear Film Thickness in Healthy Subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change of tear film thickness
研究概览
简要总结
The use of topical anesthesia as well as corneal vital staining with fluorescein is an inevitable part of various ophthalmological examinations and surgical treatments. However, eye drops that don't come in single dose packages are required to contain preservatives such as chlorhexidine diacetate. An increasing number of surveys proves the partly severe side effects that preservative-containing eye drops may induce. The aim of the present study therefore is to investigate the effects of four different topical diagnostic eye drops (Novain®, Minims Oxybuprocaine Hydrochloride®, Thilorbin® and Minims®) on tear film thickness in healthy subjects. Tear film thickness will be measured at baseline and at defined time points after single instillation. The course of tear film thickness during the study day will provide information about the influence on tear film stability of the four different eye drops. Healthy subjects will receive Novain®, Minims Oxybuprocaine Hydrochloride®, Thilorbin® and Minims® eye drops on 4 different study days in a randomized order. Assessment of lipid layer thickness will be performed before and at pre-specified time points after instillation as secondary outcome. Other clinical measures such as determination of tear film break up time (TFBUT), corneal sensation, and Schirmer I test will be performed. The study will be conducted in a randomized, single masked, observer blinded four-way cross-over design. Subjects will receive all four diagnostic eye drops on 4 different study days in a randomized order.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 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 at least 18 years
- •Written informed consent prior to study-related procedures
- •Normal ophthalmic findings
- •No use of eye drops including topical lubricants in the 4 weeks before screening
排除标准
- •Participation in a clinical trial in the 3 weeks preceding the study
- •Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- •Presence or history of a severe medical condition as judged by the clinical investigator
- •Intake of parasympathomimetic or anti-psychotic drugs
- •Wearing of contact lenses
- •Dry eye syndrome (Schirmer I test ≤10mm or TFBUT <10 sec.)
- •Glaucoma in the medical history
- •Treatment with corticosteroids in the 4 weeks preceding the study
- •Topical treatment with any ophthalmic drug in the 4 weeks preceding the study
- •Ocular infection or clinically significant inflammation
- •Ocular surgery in the 3 months preceding the study
- •Sjögren's syndrome
- •Stevens-Johnson syndrome
- •History of allergic conjunctivitis
- •Pregnancy, planned pregnancy or lactating
- •Known hypersensitivity to any component of the study medication
研究组 & 干预措施
Oxybuprocaine MDU
Subjects will receive 30µl of oxybuprocaine preserved in multi-dose units (MDU) in both eyes after the baseline measurements on the randomized study day
干预措施: Oxybuprocaine MDU (Drug)
Oxybuprocaine SDU
Subjects will receive 30µl of oxybuprocaine preserved in single-dose units (SDU) in both eyes after the baseline measurements on the randomized study day
干预措施: Oxybuprocaine SDU (Drug)
Fluorescein SDU
Subjects will receive 30µl of fluorescein preserved in single-dose units (SDU) in both eyes after the baseline measurements on the randomized study day
干预措施: Fluorescein SDU (Drug)
Oxybuprocaine/fluorescein SDU
Subjects will receive 30µl of oxybuprocaine/fluorescein preserved in single-dose units (SDU) in both eyes after the baseline measurements on the randomized study day
干预措施: Oxybuprocaine/fluorescein SDU (Drug)
结局指标
主要结局
Change of tear film thickness
时间窗: Predose and at defined time points (10±5, 20±5, 40±5, 60±5, 120±10 and 240±10 minutes) after single instillation
Change of tear film thickness as measured with optical coherence tomography predose and at defined time points (10±5, 20±5, 40±5, 60±5, 120±10 and 240±10 minutes) after single instillation
次要结局
- Corneal Sensation(Predose and at defined time points (10±5, 20±5, 40±5, 60±5, 120±10 and 240±10 minutes) after single instillation)
- Tear film break up time(Change of tear film break up time predose 240±10 minutes after single instillation)
- Schirmer 1 test(Baseline to 240±10 minutes after single instillation)
研究者
Doreen Schmidl
Assoc.Prof. PD Dr., PhD
Medical University of Vienna