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

March 7, 2023 updated by: Doreen Schmidl, Medical University of Vienna

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna, Department of Clinical Pharmacology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Concentration of omega-3 fatty acids/ASS detectable in Schirmer's tear strips using mass spectrometry
Time Frame: one week
one week
Change of nAUC (normalised area under the curve) of tear fluid metabolics from baseline to follow-up visit using mass spectrometry
Time Frame: one week
one week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To evaluate the influence of omega-3 FA/ASS on lipid layer thickness
Time Frame: one week
Lipid layer thickness will be measured by LipiView and expressed as nanometers
one week
To evaluate the influence of omega-3 FA/ASS on corneal sensation
Time Frame: one week
Corneal sensation as measured by a Cochet-Bonnet aesthesiometer will be expressed as milimeters
one week
To evaluate the influence of omega-3 FA/ASS on tear film break up time
Time Frame: one week
Tear film break up time will be measured clinically and expressed as seconds
one week
To evaluate the influence of omega-3 FA/ASS on Schirmer-1 test
Time Frame: one week
Schirmer-1 test will be expressed as milimetres/5 minutes
one week
To evaluate the influence of omega-3 FA/ASS on choroidal perfusion
Time Frame: one week
choroidal perfusion will be measured using a LSFG device and expressed as mean blur rate
one week
To evaluate the influence of omega-3 FA/ASS on central macular thickness
Time Frame: one week
central macular thickness will be measured by OCT and expressed as µm
one week
To evaluate the influence of omega-3 FA/ASS on vessel density as assessed by optical coherence tomography angiography
Time Frame: one week
vessel density will be measured by OCTA
one week
To evaluate the influence of omega-3 FA/ASS on tear film osmolarity
Time Frame: one week
tear film osmolarity will be measured by TearLab and expressed as mOsm/L
one week
Concentration of omega-3 fatty acids/ASS detectable in finger sweat samples and blood samples using mass spectrometry
Time Frame: one week
one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 21, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 24, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OPHT-300920

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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