Metabolites of Tear Fluid (Metabol-T)

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

The pilot trial evaluates the use of modified Schirmer strips and is designed to evaluate inter-individual range of metabolites in tear film.

Condition or disease	Intervention/treatment
Healthy Subjects	Diagnostic Test: Tear Sampling

Detailed Description:

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 Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:

Diagnostic Test: Tear Sampling
comprehensive eye exam, Schirmer test, break-up time, tear sampling

Outcome Measures

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Primary Outcome Measures :

1. concentration of analytes (lipids, proteins/amino acids) [ Time Frame: 3 days per patient ]
   level of analytes (ng/ml)
2. number of detecatable analytes [ Time Frame: 3 days per patient ]
   number of analytes (lipds, proteins/amino acids)

Biospecimen Retention:   Samples Without DNA

Tear fluid

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

healthy volunteers without any eye condition and normal anterior surface

Criteria

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

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

Locations

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

Sponsors and Collaborators

University Hospital Tuebingen

Institute of Ophthalmic Research Tuebingen

Institute for Clinical Epidemiology and Applied Biometry Tuebingen

Investigators

Principal Investigator:	Focke Ziemssen, MD	Center for Ophthalmology, University of Tuebingen

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	University Hospital Tuebingen
ClinicalTrials.gov Identifier:	NCT03389282 History of Changes
Other Study ID Numbers:	AZ 277/2013BO2
First Posted:	January 3, 2018
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