NCT03389282

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 3, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

January 3, 2018

Status Verified

October 1, 2017

Enrollment Period

3.1 years

First QC Date

December 20, 2017

Last Update Submit

January 2, 2018

Conditions

Healthy Subjects

Keywords

Tear, Metabolite

Outcome Measures

Primary Outcomes (2)

  • 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

Interventions

Tear SamplingDIAGNOSTIC_TEST

comprehensive eye exam, Schirmer test, break-up time, tear sampling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

healthy volunteers without any eye condition and normal anterior surface

You may qualify if:

  • healthy subjects at age \> 18 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Eye Hospital

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tear fluid

MeSH Terms

Conditions

Lacerations

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Focke Ziemssen, MD

    Center for Ophthalmology, University of Tuebingen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Focke Ziemssen, MD

CONTACT

+49 7071 29 84762focke.ziemssen@med.uni-tuebingen.de

Sascha Dammeier, PhD

CONTACT

+49 7071 29 84955sascha.dammeier@uni-tuebingen.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2017

First Posted

January 3, 2018

Study Start

November 1, 2013

Primary Completion

December 1, 2016

Study Completion

April 1, 2018

Last Updated

January 3, 2018

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)