Clinical trial NCT03389282: Metabolites of Tear Fluid
Official title: Metabolites of Tear Fluid - Evaluation in a Clinical Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy Subjects
Keywords: Tear, Metabolite
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: Institute of Ophthalmic Research Tuebingen
name: Institute for Clinical Epidemiology and Applied Biometry Tuebingen
First posted: 2018-01-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: healthy volunteers without any eye condition and normal anterior surface

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.

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.

Eligibility 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

Primary outcomes:
measure: concentration of analytes (lipids, proteins/amino acids)
timeFrame: 3 days per patient
measure: number of detecatable analytes
timeFrame: 3 days per patient
Secondary outcomes:
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Eye Hospital
state: BW
Study officials:
affiliation: Center for Ophthalmology, University of Tuebingen
name: Focke Ziemssen, MD
role: PRINCIPAL_INVESTIGATOR
References: