Effect of Eye Make up on Ocular Surface | NCT04478955

Studies
Effect of Eye Make up on Ocular Surface

NCT04478955

Sponsor

Erol Olcok Corum Training and Research Hospital

Status

Unknown status

Last Update Posted

Jul 21, 2020Actual

Enrollment

80Estimated

Phase

Not provided

Conditions

Meibomian Gland Dysfunction

Interventions

Schirmer test

Countries

Turkey (Türkiye)

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

Jul 2020

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

Jul 1, 2020Actual

Primary Completion Date

Jul 29, 2020Estimated

Completion Date

Aug 1, 2020Estimated

First Submitted Date

Jul 16, 2020

First Submission Date that Met QC Criteria

Jul 16, 2020

First Posted Date

Jul 21, 2020Actual

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

Jul 16, 2020

Last Update Posted Date

Jul 21, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Zeynep Eylül Ercan, Doctor, Erol Olcok Corum Training and Research HospitalPrincipal Investigator

Lead Sponsor

Erol Olcok Corum Training and Research HospitalOTHER

Collaborators

Not provided

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 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.

Detailed Description

Not provided

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

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Schirmer test	Diagnostic Test	Tear tests Meibomian gland grading test	eyeliner and mascara eyeliner only mascara only normal

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Schirmer test	Tear measurement	5 minutes

Secondary Outcomes

Measure	Description	Time Frame
Non contact tear break up test	tear stability calculation	17 seconds
Meibomography	Meibomian gland loss grading	2 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

any systemic or ocular disease taht can affect ocular surface

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

eye make up use

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ErolOlcok Corum WEducatin and Research Hospital	Recruiting	Çorum		19000	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D000080343	Meibomian Gland Dysfunction

Ancestor Terms

ID	Term
D005141	Eyelid Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017155	Wettability

Ancestor Terms

ID	Term
D057927	Hydrophobic and Hydrophilic Interactions
D055598	Chemical Phenomena
D013499	Surface Properties

Browse Leaves

Not provided

Browse Branches

Not provided