Dry EyePhase 2NCT05775536
Detection of Acetylsalicylic Acid and Omega-3 Fatty Acids in Schirmers' Test Strips Using Mass Spectrometry
A Phase 2 study testing Aspirin 500Mg Tab and Dr. Böhm® Omega 3 complex 870 mg in people with Dry Eye, run by Medical University of Vienna at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- Aspirin 500Mg Tab and Dr. Böhm® Omega 3 complex 870 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteAustria
- Study dates
- 21 Jan 2021to 30 Nov 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Vienna, Department of Clinical Pharmacology
Vienna, 1090
About this study
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
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.
- Conditions
- Dry Eye
- Being tested
- Aspirin 500Mg Tab, Dr. Böhm® Omega 3 complex 870 mg
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin 500Mg TabDrug
Dose: 1 tablet per day starting from visit 2 until visit 3, intake in the evening
Dr. Böhm® Omega 3 complex 870 mgDietary supplement
Dose: 2 tablets per day starting from visit 2 until visit 3, intake in the evening
| Study group | Role | What they receive |
|---|---|---|
| Aspirin® 500 mg tablets | Experimental | 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 Receives: Drug: Aspirin 500Mg Tab |
| Dr. Böhm® Omega 3 complex 870 mg | Experimental | Dose: 2 tablets per day starting from visit 2 until visit 3, intake in the evening Receives: Dietary Supplement: Dr. Böhm® Omega 3 complex 870 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of omega-3 fatty acids/ASS detectable in Schirmer's tear strips using mass spectrometry
Measured: one week
Change of nAUC (normalised area under the curve) of tear fluid metabolics from baseline to follow-up visit using mass spectrometry
Measured: one week
Secondary outcomes (9)
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
Measured: one week
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
Measured: one week
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
Measured: one week
To evaluate the influence of omega-3 FA/ASS on Schirmer-1 test
Schirmer-1 test will be expressed as milimetres/5 minutes
Measured: one week
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
Measured: one week
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
Measured: one week
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
Measured: one week
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
Measured: one week
Concentration of omega-3 fatty acids/ASS detectable in finger sweat samples and blood samples using mass spectrometry
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start21 Jan 2021
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doreen Schmidl, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05775536
- Sponsor's protocol ID
- OPHT-300920
- Status last verified
- Mar 2023
- First submitted
- 24 Feb 2023
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05775536
- Acronym / sponsor ID
- OPHT-300920
- Conditions
- Dry Eye
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin® 500 mg tablets | Experimental | Drug: Aspirin 500Mg TabDose: 1 tablet per day starting from visit 2 until visit 3, intake in the evening Ingredients: 500 mg acetylsalicylic acid, Cellulose powder, maize starche |
| Dr. Böhm® Omega 3 complex 870 mg | Experimental | Dietary Supplement: Dr. Böhm® Omega 3 complex 870 mgDose: 2 tablets per day starting from visit 2 until visit 3, intake in the evening |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirin 500Mg TabDose: 1 tablet per day starting from visit 2 until visit 3, intake in the evening | Drug | Aspirin® 500 mg tablets |
| Dr. Böhm® Omega 3 complex 870 mgDose: 2 tablets per day starting from visit 2 until visit 3, intake in the evening | Dietary supplement | Dr. Böhm® Omega 3 complex 870 mg |
Primary outcome
Concentration of omega-3 fatty acids/ASS detectable in Schirmer's tear strips using mass spectrometry
Time frame: 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
9 secondary outcomes
To evaluate the influence of omega-3 FA/ASS on lipid layer thickness
Time frame: one week
To evaluate the influence of omega-3 FA/ASS on corneal sensation
Time frame: one week
To evaluate the influence of omega-3 FA/ASS on tear film break up time
Time frame: one week
To evaluate the influence of omega-3 FA/ASS on Schirmer-1 test
Time frame: one week
To evaluate the influence of omega-3 FA/ASS on choroidal perfusion
Time frame: one week
To evaluate the influence of omega-3 FA/ASS on central macular thickness
Time frame: 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
To evaluate the influence of omega-3 FA/ASS on tear film osmolarity
Time frame: one week
Concentration of omega-3 fatty acids/ASS detectable in finger sweat samples and blood samples using mass spectrometry
Time frame: one week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Dry Eye
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aspirin 500Mg Tab and Dr. Böhm® Omega 3 complex 870 mg in people with Dry Eye, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of omega-3 fatty acids/ASS detectable in Schirmer's tear strips using mass spectrometry (time frame: one week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2023.