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临床试验/NCT05775536
NCT05775536已完成2 期

Detection of Acetylsalicylic Acid and Omega-3 Fatty Acids in Schirmers' Test Strips Using Mass Spectrometry and Correlations With Tear Film and Blood Flow Parameters in Healthy Adults: an Open-label Pilot Study

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2021年1月21日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
32
试验地点
1
主要终点
Concentration of omega-3 fatty acids/ASS detectable in Schirmer's tear strips using mass spectrometry

研究概览

简要总结

Evaluation of tear fluid production using Schirmers' tests is a well-known and frequently used examination method in ophthalmology. Schirmers' test objectively indicates the tear fluid production over five minutes by insertion of a filter paper strip in the lower conjunctival fornix. Commonly, this method is used to quantify tear fluid production, but not tear fluid composition. The development of novel, very precise analytical methods opens up new possibilities in the use and application of Schirmers' test strips. A recently introduced analytical method is mass spectrometry. This method allows the detection and quantification of proteins, lipids, and metabolites in very low amounts of samples. Whether systemically ingested agents such as omega-3 fatty acids or acetylsalicylic acid can be detected in tear fluid using this method remains unclear. The aim of this study is to investigate the detectability of 2 different agents (acetylsalicylic acid and omega-3 fatty acids) in Schirmers' test strips from healthy subjects after intake for 1 week by use of untargeted mass spectrometry. Participating healthy subjects will receive either acetylsalicylic acid or omega-3 fatty acids.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women age of at least 18 years to 60 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 any drugs or dietary supplements within three weeks before the first study day (except contraceptives)
  • TFBUT <10 sec.
  • Glaucoma in the medical history
  • Ocular infection or clinically significant inflammation
  • Ocular surgery in the 3 months preceding the study
  • Pregnancy, planned pregnancy or lactating
  • Known hypersensitivity to any component of the study medication

研究组 & 干预措施

Aspirin® 500 mg tablets

Experimental

Dose: 1 tablet per day starting from visit 2 until visit 3, intake in the evening Ingredients: 500 mg acetylsalicylic acid, Cellulose powder, maize starche

干预措施: Aspirin 500Mg Tab (Drug)

Dr. Böhm® Omega 3 complex 870 mg

Experimental

Dose: 2 tablets per day starting from visit 2 until visit 3, intake in the evening

干预措施: Dr. Böhm® Omega 3 complex 870 mg (Dietary Supplement)

结局指标

主要结局

Concentration of omega-3 fatty acids/ASS detectable in Schirmer's tear strips using mass spectrometry

时间窗: one week

Change of nAUC (normalised area under the curve) of tear fluid metabolics from baseline to follow-up visit using mass spectrometry

时间窗: one week

次要结局

  • To evaluate the influence of omega-3 FA/ASS on lipid layer thickness(one week)
  • To evaluate the influence of omega-3 FA/ASS on tear film break up time(one week)
  • To evaluate the influence of omega-3 FA/ASS on Schirmer-1 test(one week)
  • To evaluate the influence of omega-3 FA/ASS on choroidal perfusion(one week)
  • To evaluate the influence of omega-3 FA/ASS on corneal sensation(one week)
  • To evaluate the influence of omega-3 FA/ASS on central macular thickness(one week)
  • To evaluate the influence of omega-3 FA/ASS on vessel density as assessed by optical coherence tomography angiography(one week)
  • To evaluate the influence of omega-3 FA/ASS on tear film osmolarity(one week)
  • Concentration of omega-3 fatty acids/ASS detectable in finger sweat samples and blood samples using mass spectrometry(one week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Doreen Schmidl

Assoc. Prof. Dr. Doreen Schmidl, PhD

Medical University of Vienna

研究点 (1)

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