Detection of acetylsalicylic acid and omega-3 fatty acids in Schirmers’ test strips in healthy adults: an open-label pilot study

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

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-004978-22-AT

Enrollment

Registered

2020-11-25

Start date

2021-01-21

Completion date

Unknown

Last updated

2021-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy subjects

Interventions

Trade Name: Aspirin 500mg Tabletten Pharmaceutical Form: Tablet INN or Proposed INN: ACETYLSALICYLIC ACID CAS Number: 50-78-2 Concentration unit: mg milligram(s) Concentration type: equal Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: · Men and women aged 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 32 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: • To detect acetylsalicylic acid/omega-3 fatty acids concentrations in healthy adults in tear fluid of Schirmer test strips using untargeted mass spectrometry after intake for one week. • Change of tear fluid composition from baseline to follow-up visit;Secondary Objective: • Lipid layer thickness • Corneal sensation • Tear Film Break Up Time (TFBUT) • Schirmer I test • Concentration of omega-3 fatty acids/acetylsalicylic acid detectable in blood samples • Concentration of omega-3 fatty acids/acetylsalicylic acid detectable in sweat samples • Retinal and choroidal analysis of perfusion • Tear osmolarity (TearLab® analysis) • Optical coherence tomography / OCT-A;Primary end point(s): • Concentration of omega-3 fatty acids/acetylsalicylic acid detectable in Schirmer’s tear strips • Change of tear fluid composition from baseline to follow-up visit;Timepoint(s) of evaluation of this end point: After 7 to 10 days intake of the study medication	—

Measure

Time frame

Main Objective: • To detect acetylsalicylic acid/omega-3 fatty acids concentrations in healthy adults in tear fluid of Schirmer test strips using untargeted mass spectrometry after intake for one week. • Change of tear fluid composition from baseline to follow-up visit;Secondary Objective: • Lipid layer thickness • Corneal sensation • Tear Film Break Up Time (TFBUT) • Schirmer I test • Concentration of omega-3 fatty acids/acetylsalicylic acid detectable in blood samples • Concentration of omega-3 fatty acids/acetylsalicylic acid detectable in sweat samples • Retinal and choroidal analysis of perfusion • Tear osmolarity (TearLab® analysis) • Optical coherence tomography / OCT-A;Primary end point(s): • Concentration of omega-3 fatty acids/acetylsalicylic acid detectable in Schirmer’s tear strips • Change of tear fluid composition from baseline to follow-up visit;Timepoint(s) of evaluation of this end point: After 7 to 10 days intake of the study medication

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Secondary

Measure	Time frame
Secondary end point(s): • Lipid layer thickness • Corneal sensation • Tear Film Break Up Time (TFBUT) • Schirmer I test • Concentration of omega-3 fatty acids/acetylsalicylic acid detectable in blood samples • Concentration of omega-3 fatty acids/acetylsalicylic acid detectable in sweat samples • Retinal and choroidal analysis of perfusion • Tear osmolarity (TearLab® analysis) • Optical coherence tomography / OCT-A;Timepoint(s) of evaluation of this end point: After 7 to 10 days intake of the study medication	—

Measure

Time frame

Secondary end point(s): • Lipid layer thickness • Corneal sensation • Tear Film Break Up Time (TFBUT) • Schirmer I test • Concentration of omega-3 fatty acids/acetylsalicylic acid detectable in blood samples • Concentration of omega-3 fatty acids/acetylsalicylic acid detectable in sweat samples • Retinal and choroidal analysis of perfusion • Tear osmolarity (TearLab® analysis) • Optical coherence tomography / OCT-A;Timepoint(s) of evaluation of this end point: After 7 to 10 days intake of the study medication

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Countries

Austria

Contacts

Public ContactDepartment of Clinical Pharmacology

Medical University of Vienna

klin-pharmakologie@meduniwien.ac.at+4314040029810

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026