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

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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Drug: Aspirin 500Mg Tab; Dietary supplement: Dr. Böhm® Omega 3 complex 870 mg

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Medical University of Vienna, Department of Clinical Pharmacology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aspirin® 500 mg tablets; 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	Drug: Aspirin 500Mg Tab; Dose: 1 tablet per day starting from visit 2 until visit 3, intake in the evening
Experimental: Dr. Böhm® Omega 3 complex 870 mg; Dose: 2 tablets per day starting from visit 2 until visit 3, intake in the evening	Dietary supplement: Dr. Böhm® Omega 3 complex 870 mg; Dose: 2 tablets per day starting from visit 2 until visit 3, intake in the evening

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2021
• Primary Completion (Actual): November 30, 2021
• Study Completion (Actual): November 30, 2021

Study Registration Dates

• First Submitted: February 24, 2023
• First Submitted That Met QC Criteria: March 7, 2023
• First Posted (Actual): March 20, 2023

Study Record Updates

• Last Update Posted (Actual): March 20, 2023
• Last Update Submitted That Met QC Criteria: March 7, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: OPHT-300920

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No