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

Medical University of Vienna

Status and phase: Completed; Phase 2

Conditions: Dry Eye

Treatments: Dietary Supplement: Dr. Böhm® Omega 3 complex 870 mg; Drug: Aspirin 500Mg Tab

Study type: Interventional

Funder types: Other

Identifiers

NCT05775536

OPHT-300920

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Aspirin® 500 mg tablets

Experimental group

Description:

Dose: 1 tablet per day starting from visit 2 until visit 3, intake in the evening Ingredients: 500 mg acetylsalicylic acid, Cellulose powder, maize starche

Treatment:

Drug: Aspirin 500Mg Tab

Dr. Böhm® Omega 3 complex 870 mg

Experimental group

Description:

Dose: 2 tablets per day starting from visit 2 until visit 3, intake in the evening

Treatment:

Dietary Supplement: Dr. Böhm® Omega 3 complex 870 mg