NCT04478955

Brief Summary

The aim of this study is to compare the degree of tear film instability and severity of meibomian gland loss between subjects who use eyeliner, mascara, a combination of both and those who do not use eyeliner.

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
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 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

July 1, 2020

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 21, 2020

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2020

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

July 21, 2020

Status Verified

July 1, 2020

Enrollment Period

28 days

First QC Date

July 16, 2020

Last Update Submit

July 16, 2020

Conditions

Meibomian Gland Dysfunction

Keywords

meibomian, eyeliner

Outcome Measures

Primary Outcomes (1)

  • Schirmer test

    Tear measurement

    5 minutes

Secondary Outcomes (2)

  • Non contact tear break up test

    17 seconds

  • Meibomography

    2 minutes

Study Arms (4)

normal

no make up

Diagnostic Test: Schirmer test

eyeliner only

three days a week at least for 6 months

Diagnostic Test: Schirmer test

mascara only

three days a week at least for 6 months

Diagnostic Test: Schirmer test

eyeliner and mascara

three days a week at least for 6 months

Diagnostic Test: Schirmer test

Interventions

Schirmer testDIAGNOSTIC_TEST

Tear tests Meibomian gland grading test

Also known as: Non contact tear break up test, Meibomography
eyeliner and mascaraeyeliner onlymascara onlynormal

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailseye make up use
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

18 to 35 year old females with eyeliner, mascara or combined use for study groups 18 to 35 year old females with no make up use for control group

You may qualify if:

  • To use eyeliner/mascara or combined for at least 3 days for 6 months for study groups No routine eye make up use for the cıontrol group

You may not qualify if:

  • any systemic or ocular disease taht can affect ocular surface

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ErolOlcok Corum WEducatin and Research Hospital

Çorum, 19000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Meibomian Gland Dysfunction

Interventions

Wettability

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Hydrophobic and Hydrophilic InteractionsChemical PhenomenaSurface Properties

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

July 16, 2020

First Posted

July 21, 2020

Study Start

July 1, 2020

Primary Completion

July 29, 2020

Study Completion

August 1, 2020

Last Updated

July 21, 2020

Record last verified: 2020-07

Locations

TU(1)