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

Dry Eye Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05775536
• Other study ID #: OPHT-300920
• Status: Completed
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes

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