Metabolites of Tear Fluid

Healthy Subjects Clinical Trial

— Metabol-T  

Official title:

Metabolites of Tear Fluid - Evaluation in a Clinical Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03389282
• Other study ID #: AZ 277/2013BO2
• Status: Recruiting
• Phase: N/A
• First received: December 20, 2017
• Last updated: January 2, 2018
• Start date: November 1, 2013
• Est. completion date: April 1, 2018

Study information

• Verified date: October 2017
• Source: University Hospital Tuebingen
• Contact: Focke Ziemssen, MD
• Phone: +49 7071 29 84762
• Email: focke.ziemssen[@]med.uni-tuebingen.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 1, 2018
• Est. primary completion date: December 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

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

Locations

Country	Name	City	State
Germany	University Eye Hospital	Tuebingen	BW

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Tuebingen	Institute for Clinical Epidemiology and Applied Biometry Tuebingen, Institute of Ophthalmic Research Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	concentration of analytes (lipids, proteins/amino acids)	level of analytes (ng/ml)	3 days per patient
Primary	number of detecatable analytes	number of analytes (lipds, proteins/amino acids)	3 days per patient