The Effect of Eyeliner on Tear Composition, Tear Secretion and Tear Film Stability.

NCT ID: NCT05632887

Last Updated: 2025-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-20

Study Completion Date

2026-09-30

Brief Summary

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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

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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

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Dry Eye

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Control

The population who do not use eyeliner.

no intervention

Intervention Type OTHER

no intervention

Eyeliner

The population who using eyeliner and the duration and frequency are appropriate。

no intervention

Intervention Type OTHER

no intervention

Interventions

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no intervention

no intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Zhongnan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Min Ke

Role: STUDY_CHAIR

Ophthalmology Department of Zhongnan Hospital of Wuhan University

Locations

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Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Min Ke

Role: CONTACT

+86 18672395959

Facility Contacts

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Yanru Shen

Role: primary

15635609732

Other Identifiers

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20220920E

Identifier Type: -

Identifier Source: org_study_id

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