Clinical trial NCT05775536: Detection of Acetylsalicylic Acid and Omega-3 Fatty Acids in Schirmers' Test Strips Using Mass Spectrometry
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Concentration of omega-3 fatty acids/ASS detectable in Schirmer's tear strips using mass spectrometry
timeFrame: one week
measure: Change of nAUC (normalised area under the curve) of tear fluid metabolics from baseline to follow-up visit using mass spectrometry
timeFrame: one week
Secondary outcomes:
measure: To evaluate the influence of omega-3 FA/ASS on lipid layer thickness
timeFrame: one week
measure: To evaluate the influence of omega-3 FA/ASS on corneal sensation
timeFrame: one week
measure: To evaluate the influence of omega-3 FA/ASS on tear film break up time
timeFrame: one week
measure: To evaluate the influence of omega-3 FA/ASS on Schirmer-1 test
timeFrame: one week
measure: To evaluate the influence of omega-3 FA/ASS on choroidal perfusion
timeFrame: one week
measure: To evaluate the influence of omega-3 FA/ASS on central macular thickness
timeFrame: one week
measure: To evaluate the influence of omega-3 FA/ASS on vessel density as assessed by optical coherence tomography angiography
timeFrame: one week
measure: To evaluate the influence of omega-3 FA/ASS on tear film osmolarity
timeFrame: one week
measure: Concentration of omega-3 fatty acids/ASS detectable in finger sweat samples and blood samples using mass spectrometry
timeFrame: one week
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Department of Clinical Pharmacology
Study officials:
References: