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

Sponsor

Medical University of Vienna (Other)

Overall Status

Completed

CT.gov ID

NCT05775536

Collaborator

(none)

Enrollment

Location

Arms

10.3

Actual Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye	Drug: Aspirin 500Mg Tab Dietary Supplement: Dr. Böhm® Omega 3 complex 870 mg	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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

Actual Study Start Date :

Jan 21, 2021

Actual Primary Completion Date :

Nov 30, 2021

Actual Study Completion Date :

Nov 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Aspirin® 500 mg tablets 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	Drug: Aspirin 500Mg Tab Dose: 1 tablet per day starting from visit 2 until visit 3, intake in the evening
Experimental: Dr. Böhm® Omega 3 complex 870 mg Dose: 2 tablets 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

Arm

Intervention/Treatment

Experimental: Aspirin® 500 mg tablets

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

Drug: Aspirin 500Mg Tab

Dose: 1 tablet per day starting from visit 2 until visit 3, intake in the evening

Experimental: Dr. Böhm® Omega 3 complex 870 mg

Dose: 2 tablets 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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 corneal sensation [one week]
Corneal sensation as measured by a Cochet-Bonnet aesthesiometer will be expressed as milimeters
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 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 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Vienna, Department of Clinical Pharmacology	Vienna		Austria	1090

Sponsors and Collaborators

Medical University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Doreen Schmidl, Assoc. Prof. Dr. Doreen Schmidl, PhD, Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT05775536

Other Study ID Numbers:

OPHT-300920

First Posted:

Mar 20, 2023

Last Update Posted:

Mar 20, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Dry Eye Syndromes

Aspirin

Study Results

No Results Posted as of Mar 20, 2023