Clinical Trial Results:
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
Summary
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EudraCT number |
2020-004978-22 |
Trial protocol |
AT |
Global end of trial date |
30 Nov 2021
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Results information
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Results version number |
v1(current) |
This version publication date |
16 Apr 2023
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First version publication date |
16 Apr 2023
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
OPHT-300920
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Medical University of Vienna
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Sponsor organisation address |
Waehringer Guertel 18-20, Vienna, Austria, 1090
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Public contact |
Department of Clinical Pharmacology, Medical University of Vienna, +43 14040029810, klin-pharmakologie@meduniwien.ac.at
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Scientific contact |
Department of Clinical Pharmacology, Medical University of Vienna, +43 14040029810, klin-pharmakologie@meduniwien.ac.at
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
30 Nov 2022
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
30 Nov 2021
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Global end of trial reached? |
Yes
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Global end of trial date |
30 Nov 2021
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
• To detect acetylsalicylic acid/omega-3 fatty acids concentrations in healthy adults in tear fluid of Schirmer test strips using untargeted mass spectrometry after intake for one week.
• Change of tear fluid composition from baseline to follow-up visit
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Protection of trial subjects |
not applicable - healthy volunteers
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
24 Mar 2021
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Austria: 32
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Worldwide total number of subjects |
32
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EEA total number of subjects |
32
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
32
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
recruitment was done via the database of the department of clinical pharmacology | |||||||||
Pre-assignment
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Screening details |
The following examinations and tests were carried out in each participant in the 14 days before the first study day: 1. Informed consent 2. Medical History (including ocular medical history) 3. Pregnancy test in women with childbearing potential 4. Ophthalmic examination | |||||||||
Period 1
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Period 1 title |
active phase (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Group 1: Acetylsalicylic acid | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Aspirin® 500 mg Tabletten
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
1 tablet per day for 1 week, intake in the evening
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Arm title
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Group 2: Omega-3 fatty acids 870 mg | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Dr. Böhm® Omega 3 complex 870 mg
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
2 tablets per day for 1 week, intake in the evening
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Baseline characteristics reporting groups
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Reporting group title |
active phase
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Group 1: Acetylsalicylic acid
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Reporting group description |
- | ||
Reporting group title |
Group 2: Omega-3 fatty acids 870 mg
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Reporting group description |
- |
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End point title |
Concentration of omega-3 fatty acids/acetylsalicylic acid detectable in Schirmer’s tear strips [1] | |||||||||
End point description |
Samples have not yet been analyzed, analysis will be performed within the next 12 months.
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End point type |
Primary
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End point timeframe |
after 1 week intake of study medication
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Samples have not yet been analyzed, analysis will be performed within the next 12 months. |
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
first subject first visit - last subject last visit
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Assessment type |
Non-systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
26
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Reporting groups
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Reporting group title |
Acetylsalicylic acid
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Omega-3 fatty acids 870 mg
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 1% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |