Dry EyeNCT05632887
The Effect of Eyeliner on Tear Composition, Tear Secretion and Tear Film Stability.
An observational study of Dry Eye, run by Zhongnan Hospital at 1 site in China.
Trial summary
Eyeliner is one of the most common eye cosmetics. The main ingredients are titanium oxide, pigment, grease and preservative. The user will apply the eyeliner to the eyelid and eyelash. With the blinking again and again, the components of the eyeliner may enter the tear film and continue to act on the eye surface. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2022to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The main population of our study is the young women who do not have other diseases that affect the health of eye surface and use or do not use eyeliner.
Who may be able to join
- People aged 20-35 who use eyeliner or do not use eyeliner .
- People who use eyeliner have used it for ≥ 1 year; Frequency ≥ 3 times/week.
Who cannot join
- Other serious systemic diseases.
- Other systemic diseases related to ocular surface, such as rheumatoid arthritis, systemic lupus erythematosus, Sjogren's syndrome and other immune system diseases or other eye diseases, history of eye surgery and trauma.
- Lactating women or pregnant women.
- Use electronic products for more than 4 hours every day.
- Patients with circadian rhythm disorder.
- People with radiation exposure history.
- Non permanent residents in Wuhan.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
Yanru Shen, 15635609732, 2017302180062@whu.edu.cn
About this study
Official title: The Effect of Eyeliner on Tear Composition, Tear Secretion and Tear Film Stability：a Prospective Cohort Study.
Eyeliner is one of the most common eye cosmetics. The main ingredients are titanium oxide, pigment, grease and preservative. The user will apply the eyeliner to the eyelid and eyelash. With the blinking again and again, the components of the eyeliner may enter the tear film and continue to act on the eye surface. Therefore, the investigators suspect that the use of eyeliner may be an important factor leading to dry eye disease. In order to explore the relationship between the use of eyeliner and dry eye disease, the investigators plan to collect eye surface characteristic data of the two groups of people who use eyeliner and who do not use it.Then use Raman analysis to explore whether the use of eyeliner will lead to changes in tear composition.The investigators intend to analyze the difference of tear composition between the two groups to understand the relationship between the change of tear composition and tear film stability.So that the investigators can identify the risk factors of dry eye disease, and provide basis for prevention and early treatment.
Read the detailed description
The investigators will include the population according to the inclusion criteria and exclusion criteria.The subjects in the eyeliner group and the control group filled in the survey to score the ocular surface disease index. Tear secretion test and sodium fluorescein staining are conducted in the eyeliner group and the control group, and the results are recorded. The intraocular pressure of the two groups is measured and recorded. Dry eye analysis is conducted for the two groups of people to collect relevant data. Tears are collected by capillary glass tube and stored for further Raman analysis.
- Conditions
- Dry Eye
- Being tested
- no intervention
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| Control | The population who do not use eyeliner. Receives: Other: no intervention | |
| Eyeliner | The population who using eyeliner and the duration and frequency are appropriate。 Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Schirmer's test evaluates aqueous tear production.
Schirmer test is a simple method to measure the amount of tear secretion.It is helpful in the assessment of patients with signs and/or symptoms of dry eye as it can determine whether surface dryness is due to reduced tear production from the lacrimal glands as opposed to some other cause.Normal aqueous tear production is supported by measurements of > 15 mm after 5 minutes.Mild-moderate reduction of aqueous production: 5mm-14mm after 5 minutes.Severe dryness due to reduced tear production is <5mm after 5 minutes.
Measured: baseline
The gland loss assessed by meibography images.
The investigators can observe the morphology of meibomian gland to grade the degree of Dry Eye.The morphology was evaluated by analyzing meibography images obtained with the non-contact infrared meibography system OCULUS Keratograph 5.MG loss in each eyelid was evaluated subjectively using a four-point grading scale (meibograde) of 0-3described as : grade 0: 0-25% loss; grade 1: 26-50% loss; grade 2: 51-75% loss; and grade 3: >75% loss.
Measured: baseline
Evaluation of lipid content and ionic composition in tears by raman analysis.
The investigators can use Raman spectroscopy to compare the changes of tear composition between the two groups.Raman spectroscopy is a technique that detects vibrational motions in molecules and can be used for lipids. It is a powerful technique and often used when analyzing biological samples such as lipids and proteins because it's non-invasive, highly accurate, insignificant amount and provides abundant chemical information.The fatty acids, triglycerides, phospholipids, sphingolipids, cholesterol and carotenoids can be detected.And the investigators can use a special instruments to test Na+,K+,Mg2+ and Cl- those are very important in tear film homeostasis.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start20 Nov 2022
- Primary completion15 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies 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
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Min Ke, Study chair, Ophthalmology Department of Zhongnan Hospital of Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05632887
- Sponsor's protocol ID
- 20220920E
- Status last verified
- Sep 2025
- First submitted
- 9 Oct 2022
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Eyeliner on Tear Composition, Tear Secretion and Tear Film Stability：a Prospective Cohort Study.
- ClinicalTrials.gov ID
- NCT05632887
- Acronym / sponsor ID
- 20220920E
- Conditions
- Dry Eye
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 20 Nov 2022 (actual)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 1 Dec 2022 (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.
Eyeliner is one of the most common eye cosmetics. The main ingredients are titanium oxide, pigment, grease and preservative. The user will apply the eyeliner to the eyelid and eyelash. With the blinking again and again, the components of the eyeliner may enter the tear film and continue to act on the eye surface. Therefore, the investigators suspect that the use of eyeliner may be an important factor leading to dry eye disease. In order to explore the relationship between the use of eyeliner and dry eye disease, the investigators plan to collect eye surface characteristic data of the two groups of people who use eyeliner and who do not use it.Then use Raman analysis to explore whether the use of eyeliner will lead to changes in tear composition.The investigators intend to analyze the difference of tear composition between the two groups to understand the relationship between the change of tear composition and tear film stability.So that the investigators can identify the risk factors of dry eye disease, and provide basis for prevention and early treatment.
Detailed description
The investigators will include the population according to the inclusion criteria and exclusion criteria.The subjects in the eyeliner group and the control group filled in the survey to score the ocular surface disease index. Tear secretion test and sodium fluorescein staining are conducted in the eyeliner group and the control group, and the results are recorded. The intraocular pressure of the two groups is measured and recorded. Dry eye analysis is conducted for the two groups of people to collect relevant data. Tears are collected by capillary glass tube and stored for further Raman analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Other: no interventionThe population who do not use eyeliner. |
| Eyeliner | – | Other: no interventionThe population who using eyeliner and the duration and frequency are appropriate。 |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The main population of our study is the young women who do not have other diseases that affect the health of eye surface and use or do not use eyeliner.
Key inclusion criteria (2 listed)
- People aged 20-35 who use eyeliner or do not use eyeliner .
- People who use eyeliner have used it for ≥ 1 year; Frequency ≥ 3 times/week.
Key exclusion criteria (7 listed)
- Other serious systemic diseases.
- Other systemic diseases related to ocular surface, such as rheumatoid arthritis, systemic lupus erythematosus, Sjogren's syndrome and other immune system diseases or other eye diseases, history of eye surgery and trauma.
- Lactating women or pregnant women.
- Use electronic products for more than 4 hours every day.
- Patients with circadian rhythm disorder.
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 |
|---|---|---|
| no interventionno intervention | Other | Control, Eyeliner |
Primary outcome
The Schirmer's test evaluates aqueous tear production.
Time frame: baseline
Schirmer test is a simple method to measure the amount of tear secretion.It is helpful in the assessment of patients with signs and/or symptoms of dry eye as it can determine whether surface dryness is due to reduced tear production from the lacrimal glands as opposed to some other cause.Normal aqueous tear production is supported by measurements of > 15 mm after 5 minutes.Mild-moderate reduction of aqueous production: 5mm-14mm after 5 minutes.Severe dryness due to reduced tear production is <5mm after 5 minutes.
The gland loss assessed by meibography images.
Time frame: baseline
The investigators can observe the morphology of meibomian gland to grade the degree of Dry Eye.The morphology was evaluated by analyzing meibography images obtained with the non-contact infrared meibography system OCULUS Keratograph 5.MG loss in each eyelid was evaluated subjectively using a four-point grading scale (meibograde) of 0-3described as : grade 0: 0-25% loss; grade 1: 26-50% loss; grade 2: 51-75% loss; and grade 3: >75% loss.
Evaluation of lipid content and ionic composition in tears by raman analysis.
Time frame: baseline
The investigators can use Raman spectroscopy to compare the changes of tear composition between the two groups.Raman spectroscopy is a technique that detects vibrational motions in molecules and can be used for lipids. It is a powerful technique and often used when analyzing biological samples such as lipids and proteins because it's non-invasive, highly accurate, insignificant amount and provides abundant chemical information.The fatty acids, triglycerides, phospholipids, sphingolipids, cholesterol and carotenoids can be detected.And the investigators can use a special instruments to test Na+,K+,Mg2+ and Cl- those are very important in tear film homeostasis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Min Ke study chair
Ophthalmology Department of Zhongnan Hospital of Wuhan University
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 Dry Eye, run by Zhongnan Hospital at 1 site in China.
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 7 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: looking for participants now, as of the sponsor's last update on 29 Sep 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Min Ke (+86 18672395959, keminyk@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Schirmer's test evaluates aqueous tear production. (time frame: baseline). The study lists 3 primary outcomes in all. 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 29 Sep 2025; AzTrials last refreshed its copy on 7 Nov 2026.