Metabolites of Tear Fluid | NCT03389282

Studies
Metabolites of Tear Fluid

NCT03389282

Sponsor

University Hospital Tuebingen

Status

Unknown status

Last Update Posted

Jan 3, 2018Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Healthy Subjects

Interventions

Tear Sampling

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2013Actual

Primary Completion Date

Dec 1, 2016Actual

Completion Date

Apr 1, 2018Estimated

First Submitted Date

Dec 20, 2017

First Submission Date that Met QC Criteria

Jan 2, 2018

First Posted Date

Jan 3, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 2, 2018

Last Update Posted Date

Jan 3, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

University Hospital TuebingenOTHER

Collaborators

Name	Class
Institute of Ophthalmic Research Tuebingen	UNKNOWN
Institute for Clinical Epidemiology and Applied Biometry Tuebingen	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tear Sampling	Diagnostic Test	comprehensive eye exam, Schirmer test, break-up time, tear sampling

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

healthy volunteers without any eye condition and normal anterior surface

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Focke Ziemssen, MD	Contact	+49 7071 29 84762		focke.ziemssen@med.uni-tuebingen.de
Sascha Dammeier, PhD	Contact	+49 7071 29 84955		sascha.dammeier@uni-tuebingen.de

Overall Officials

Name	Affiliation	Role
Focke Ziemssen, MD	Center for Ophthalmology, University of Tuebingen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Eye Hospital	Recruiting	Tübingen	Baden-Wurttemberg	72076	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D022125	Lacerations

Ancestor Terms

ID	Term
D014947	Wounds and Injuries

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Browse Branches

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