Detection of Acetylsalicylic Acid and Omega-3 Fatty Acids in Schirmers' Test Strips Using Mass Spectrometry

Phase 2

Completed

Interventions: Drug: Aspirin 500Mg Tab
Dietary Supplement: Dr. Böhm® Omega 3 complex 870 mg

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Aspirin® 500 mg tablets	Aspirin 500Mg Tab	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
Dr. Böhm® Omega 3 complex 870 mg	Dr. Böhm® Omega 3 complex 870 mg	Dose: 2 tablets per day starting from visit 2 until visit 3, intake in the evening

Primary Outcome Measures

Name	Time	Method
Concentration of omega-3 fatty acids/ASS detectable in Schirmer's tear strips using mass spectrometry	one week
Change of nAUC (normalised area under the curve) of tear fluid metabolics from baseline to follow-up visit using mass spectrometry	one week

Secondary Outcome Measures

Name	Time	Method
To evaluate the influence of omega-3 FA/ASS on lipid layer thickness	one week	Lipid layer thickness will be measured by LipiView and expressed as nanometers
To evaluate the influence of omega-3 FA/ASS on tear film break up time	one week	Tear film break up time will be measured clinically and expressed as seconds
To evaluate the influence of omega-3 FA/ASS on Schirmer-1 test	one week	Schirmer-1 test will be expressed as milimetres/5 minutes
To evaluate the influence of omega-3 FA/ASS on choroidal perfusion	one week	choroidal perfusion will be measured using a LSFG device and expressed as mean blur rate
To evaluate the influence of omega-3 FA/ASS on central macular thickness	one week	central macular thickness will be measured by OCT and expressed as µm
To evaluate the influence of omega-3 FA/ASS on vessel density as assessed by optical coherence tomography angiography	one week	vessel density will be measured by OCTA
To evaluate the influence of omega-3 FA/ASS on tear film osmolarity	one week	tear film osmolarity will be measured by TearLab and expressed as mOsm/L
To evaluate the influence of omega-3 FA/ASS on corneal sensation	one week	Corneal sensation as measured by a Cochet-Bonnet aesthesiometer will be expressed as milimeters
Concentration of omega-3 fatty acids/ASS detectable in finger sweat samples and blood samples using mass spectrometry	one week

Locations (1): Medical University of Vienna, Department of Clinical Pharmacology
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Vienna, Austria