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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05775536
Other study ID # OPHT-300920
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date January 21, 2021
Est. completion date November 30, 2021

Study information

Verified date March 2023
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date November 30, 2021
Est. primary completion date November 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Aspirin 500Mg Tab
Dose: 1 tablet 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

Locations

Country Name City State
Austria Medical University of Vienna, Department of Clinical Pharmacology Vienna

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Concentration of omega-3 fatty acids/ASS detectable in Schirmer's tear strips using mass spectrometry one week
Primary Change of nAUC (normalised area under the curve) of tear fluid metabolics from baseline to follow-up visit using mass spectrometry one week
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Concentration of omega-3 fatty acids/ASS detectable in finger sweat samples and blood samples using mass spectrometry one week
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