Meibomian Gland DysfunctionNCT04478955
Effect of Eye Make up on Ocular Surface
An observational study of Meibomian Gland Dysfunction, run by Erol Olcok Corum Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Meibomian Gland Dysfunction
- What is being tested?
- Schirmer test
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2020to 1 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- 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
Who may be able to join
- 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
- -
Who cannot join
- any systemic or ocular disease taht can affect ocular surface
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
ErolOlcok Corum WEducatin and Research Hospital
Çorum, 19000
Zeynep E Ercan, MD, 905322059636, zeynepeylul.ercan@saglik.gov.tr
About this study
Official title: Effect of Pencil Eyeliners and Waterproof Mascara on Tear Stability Tests and Meibomography
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.
- Conditions
- Meibomian Gland Dysfunction
- Being tested
- Schirmer test
- Keywords
- meibomian, eyeliner
- Medical subject headings
- Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Schirmer testDiagnostic test
Also called Non contact tear break up test, Meibomography
Tear tests Meibomian gland grading test
| Study group | Role | What they receive |
|---|---|---|
| normal | no make up Receives: Diagnostic Test: Schirmer test | |
| eyeliner only | three days a week at least for 6 months Receives: Diagnostic Test: Schirmer test | |
| mascara only | three days a week at least for 6 months Receives: Diagnostic Test: Schirmer test | |
| eyeliner and mascara | three days a week at least for 6 months Receives: Diagnostic Test: Schirmer test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Schirmer test
Tear measurement
Measured: 5 minutes
Secondary outcomes (2)
Non contact tear break up test
tear stability calculation
Measured: 17 seconds
Meibomography
Meibomian gland loss grading
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start1 Jul 2020
- Primary completion29 Jul 2020 (estimated)
- Study completion1 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meibomian Gland DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erol Olcok Corum Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Eylül Ercan, Erol Olcok Corum Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04478955
- Sponsor's protocol ID
- Corum State Hospital
- Status last verified
- Jul 2020
- First submitted
- 16 Jul 2020
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pencil Eyeliners and Waterproof Mascara on Tear Stability Tests and Meibomography
- ClinicalTrials.gov ID
- NCT04478955
- Acronym / sponsor ID
- Corum State Hospital
- Conditions
- Meibomian Gland Dysfunction
- Keywords
- meibomian, eyeliner
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Erol Olcok Corum Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 29 Jul 2020 (estimated)
- Study completion
- 1 Aug 2020 (estimated)
- First posted
- 21 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| normal | – | Diagnostic Test: Schirmer testno make up |
| eyeliner only | – | Diagnostic Test: Schirmer testthree days a week at least for 6 months |
| mascara only | – | Diagnostic Test: Schirmer testthree days a week at least for 6 months |
| eyeliner and mascara | – | Diagnostic Test: Schirmer testthree days a week at least for 6 months |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Age groups
- 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
Key inclusion criteria (2 listed)
- 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
- -
Key exclusion criteria (1 listed)
- any systemic or ocular disease taht can affect ocular surface
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Schirmer testAlso: Non contact tear break up test, MeibomographyTear tests Meibomian gland grading test | Diagnostic test | eyeliner and mascara, eyeliner only, mascara only, normal |
Primary outcome
Schirmer test
Time frame: 5 minutes
Tear measurement
2 secondary outcomes
Non contact tear break up test
Time frame: 17 seconds
Meibomography
Time frame: 2 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ErolOlcok Corum WEducatin and Research Hospital
Çorum, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meibomian Gland Dysfunction, run by Erol Olcok Corum Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Schirmer test (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2020.