Dry Eye
Conditions
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.
Interventions
DRUGAspirin 500Mg Tab
Dose: 1 tablet per day starting from visit 2 until visit 3, intake in the evening
DIETARY_SUPPLEMENTDr. Böhm® Omega 3 complex 870 mg
Dose: 2 tablets per day starting from visit 2 until visit 3, intake in the evening
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 |
| Concentration of omega-3 fatty acids/ASS detectable in finger sweat samples and blood samples using mass spectrometry | one week | — |
| 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 corneal sensation | one week | Corneal sensation as measured by a Cochet-Bonnet aesthesiometer will be expressed as milimeters |
Countries
Austria
Outcome results
None listed