Metabolites of Tear Fluid (Metabol-T)

Metabolites of Tear Fluid - Evaluation in a Clinical Pilot Study

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

Study Overview

• Status: Unknown
• Conditions: Healthy Subjects
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• Germany
  • BW
    • Tuebingen, BW, Germany, 72076
      • Recruiting
      • University Eye Hospital
      • Contact: Focke Ziemssen, MD; Phone Number: 0049 7071 29 84761; Email: Focke.Ziemssen@med.uni-tuebingen.de
      • Principal Investigator: Focke Ziemssen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

healthy volunteers without any eye condition and normal anterior surface

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
concentration of analytes (lipids, proteins/amino acids)	level of analytes (ng/ml)	3 days per patient
number of detecatable analytes	number of analytes (lipds, proteins/amino acids)	3 days per patient

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2013
• Primary Completion (Actual): December 1, 2016
• Study Completion (Anticipated): April 1, 2018

Study Registration Dates

• First Submitted: December 20, 2017
• First Submitted That Met QC Criteria: January 2, 2018
• First Posted (Actual): January 3, 2018

Study Record Updates

• Last Update Posted (Actual): January 3, 2018
• Last Update Submitted That Met QC Criteria: January 2, 2018
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Tear, Metabolite
• Other Study ID Numbers: AZ 277/2013BO2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No