Detection of acetylsalicylic acid and omega-3 fatty acids in Schirmers’ test strips in healthy adults: an open-label pilot study
- Conditions
- Healthy subjectsTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
- Registration Number
- EUCTR2020-004978-22-AT
- Lead Sponsor
- Medical University of Vienna, Department of Clinical Pharmacology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 32
·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
·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 & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>•Change of tear fluid composition from baseline to follow-up visit;Secondary Objective: •Lipid layer thickness <br>•Corneal sensation <br>•Tear Film Break Up Time (TFBUT)<br>•Schirmer I test<br>•Concentration of omega-3 fatty acids/acetylsalicylic acid detectable in blood samples<br>•Concentration of omega-3 fatty acids/acetylsalicylic acid detectable in sweat samples<br>•Retinal and choroidal analysis of perfusion<br>•Tear osmolarity (TearLab® analysis)<br>•Optical coherence tomography / OCT-A;Primary end point(s): •Concentration of omega-3 fatty acids/acetylsalicylic acid detectable in Schirmer’s tear strips<br>•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
- Secondary Outcome Measures
Name Time Method Secondary end point(s): •Lipid layer thickness <br>•Corneal sensation <br>•Tear Film Break Up Time (TFBUT)<br>•Schirmer I test<br>•Concentration of omega-3 fatty acids/acetylsalicylic acid detectable in blood samples<br>•Concentration of omega-3 fatty acids/acetylsalicylic acid detectable in sweat samples<br>•Retinal and choroidal analysis of perfusion<br>•Tear osmolarity (TearLab® analysis)<br>•Optical coherence tomography / OCT-A;Timepoint(s) of evaluation of this end point: After 7 to 10 days intake of the study medication