Metabolites of Tear Fluid (Metabol-T)
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ClinicalTrials.gov Identifier: NCT03389282 |
Recruitment Status
:
Recruiting
First Posted
: January 3, 2018
Last Update Posted
: January 3, 2018
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Condition or disease | Intervention/treatment |
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Healthy Subjects | Diagnostic Test: Tear Sampling |
The variability of tear film metabolites should be investigated in a sample of ophthalmologists in preparation for a pilot study in patients eye diseases.
The easy accessibility of the tear fluid and the lack of invasiveness of the study make it promising and sensible to determine the concentration of various tear film metabolites. Because attention has so far focused primarily on the quantitative and qualitative analysis of tear film proteins, many metabolites have so far only been shown to be contained in tears.
However, before the suitability of the measured values as a predictive parameter of the ocular surface for pathologies can be examined and assessed, it is necessary to determine the scattering variables in a sample of healthy volunteers. Thus, reference areas are to be defined for later investigations in order to enable reliable case number planning thereafter.
Repeated determinations at different times and on different days make it possible in particular to detect a time-dependent relationship in view of the dynamic variability of the tear film. The functional significance of certain metabolites can not yet be assessed in the establishment phase. However, the data may provide important information for the interpretation of a later, planned feasibility study with diseased patients or the influence of applied eye drops.
Study Type : | Observational |
Estimated Enrollment : | 30 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Metabolites of Tear Fluid - Evaluation in a Clinical Pilot Study |
Actual Study Start Date : | November 1, 2013 |
Actual Primary Completion Date : | December 1, 2016 |
Estimated Study Completion Date : | April 1, 2018 |

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Diagnostic Test: Tear Sampling
- concentration of analytes (lipids, proteins/amino acids) [ Time Frame: 3 days per patient ]level of analytes (ng/ml)
- number of detecatable analytes [ Time Frame: 3 days per patient ]number of analytes (lipds, proteins/amino acids)
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- healthy subjects at age > 18 years
Exclusion Criteria:
- in the case of subjects with a mental disability or legal guardianship, due to possible conflicts for the caregivers, a data evaluation and recording should in principle be dispensed with.
- subjects who have had any eye drops within the last 4 weeks, e.g. lubricants were used
- subjects undergoing clinical examination for symptoms of wetting disorder or morphological changes related to eye disease

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03389282
Contact: Focke Ziemssen, MD | +49 7071 29 84762 | focke.ziemssen@med.uni-tuebingen.de | |
Contact: Sascha Dammeier, PhD | +49 7071 29 84955 | sascha.dammeier@uni-tuebingen.de |
Germany | |
University Eye Hospital | Recruiting |
Tuebingen, BW, Germany, 72076 | |
Contact: Focke Ziemssen, MD 0049 7071 29 84761 Focke.Ziemssen@med.uni-tuebingen.de | |
Principal Investigator: Focke Ziemssen, MD |
Principal Investigator: | Focke Ziemssen, MD | Center for Ophthalmology, University of Tuebingen |
Responsible Party: | University Hospital Tuebingen |
ClinicalTrials.gov Identifier: | NCT03389282 History of Changes |
Other Study ID Numbers: |
AZ 277/2013BO2 |
First Posted: | January 3, 2018 Key Record Dates |
Last Update Posted: | January 3, 2018 |
Last Verified: | October 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No | |
Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by University Hospital Tuebingen:
Tear, Metabolite |