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NCT Number: NCT05775536

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

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.

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medical University of Vienna, Department of Clinical Pharmacology

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aspirin 500Mg Tab

Drug

Dose: 1 tablet per day starting from visit 2 until visit 3, intake in the evening

Dr. Böhm® Omega 3 complex 870 mg

Dietary Supplement

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

Primary outcomes

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

    Time frame: one week

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

    Time frame: one week

Secondary outcomes

  1. To evaluate the influence of omega-3 FA/ASS on lipid layer thickness

    Time frame: one week

    Lipid layer thickness will be measured by LipiView and expressed as nanometers

  2. To evaluate the influence of omega-3 FA/ASS on corneal sensation

    Time frame: one week

    Corneal sensation as measured by a Cochet-Bonnet aesthesiometer will be expressed as milimeters

  3. To evaluate the influence of omega-3 FA/ASS on tear film break up time

    Time frame: one week

    Tear film break up time will be measured clinically and expressed as seconds

  4. To evaluate the influence of omega-3 FA/ASS on Schirmer-1 test

    Time frame: one week

    Schirmer-1 test will be expressed as milimetres/5 minutes

  5. To evaluate the influence of omega-3 FA/ASS on choroidal perfusion

    Time frame: one week

    choroidal perfusion will be measured using a LSFG device and expressed as mean blur rate

  6. To evaluate the influence of omega-3 FA/ASS on central macular thickness

    Time frame: one week

    central macular thickness will be measured by OCT and expressed as µm

  7. To evaluate the influence of omega-3 FA/ASS on vessel density as assessed by optical coherence tomography angiography

    Time frame: one week

    vessel density will be measured by OCTA

  8. To evaluate the influence of omega-3 FA/ASS on tear film osmolarity

    Time frame: one week

    tear film osmolarity will be measured by TearLab and expressed as mOsm/L

  9. Concentration of omega-3 fatty acids/ASS detectable in finger sweat samples and blood samples using mass spectrometry

    Time frame: one week

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 20, 2023
Registry last updated
Mar 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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