NCT05604651

Brief Summary

The study aimed to evaluate 1) if levels of the glycocalyx membrane mucins, including MUC1, MUC4, MUC16 and MUC20, are altered in conjunctival cells of visual display users With and Without Dry Eye Disease, and 2) if mucin levels correlate with dry eye clinical diagnostic data.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 3, 2022

Completed
Last Updated

November 23, 2022

Status Verified

October 1, 2022

Enrollment Period

6 months

First QC Date

October 29, 2022

Last Update Submit

November 20, 2022

Conditions

Keywords

Dry Eye DiseaseMucin

Outcome Measures

Primary Outcomes (1)

  • mucin expression

    The mRNA expression of mucin was measured by Quantitative real-time PCR, which is a laboratory technique of molecular biology to find out how much of a specific section of DNA there is in a sample.

    immediately after meeting the inclusion and exclusion criteria

Study Arms (2)

dry eye disease

Dry eye disease was diagnosed according to the Tear Film and Ocular Surface Society (TFOS) DEWS II criteria: (1) Ocular Surface Disease Index (OSDI) score ≥ 13 and (2) one of these signs; fluorescein tear breakup time (TBUT) \<10 sec; abnormal ocular surface staining (\>5 corneal spots or \> 9 conjunctival spots).

Other: no intervention

control

The controll group enrolled healthy participants without ocular and systemic diseases.

Other: no intervention

Interventions

no intervention

controldry eye disease

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Video display terminals users with and without dry eye disease.

You may qualify if:

  • Participants who exposed to video display terminals for more than 1 year (at least 5 days per week and 6 hours per day) were enrolled and divided into two groups: (1) VDT users with DED and (2) VDT users without DED. DED was diagnosed according to the Tear Film and Ocular Surface Society (TFOS) DEWS II criteria: (1) Ocular Surface Disease Index (OSDI) score ≥ 13 and (2) one of these signs; fluorescein tear breakup time (TBUT) \<10 sec; abnormal ocular surface staining (\>5 corneal spots or \> 9 conjunctival spots).

You may not qualify if:

  • a history of contact lens wear or ocular surgery within 2 year of the study visit; a history of previous ocular disease; topical or systemic therapies other than artificial tears within two weeks before recruitment; and inflammatory ocular diseases, ocular surface diseases, glaucoma and systemic diseases with ocular involvement, such as meibomian gland dysfunction, diabetes, and peripheral neuropathy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, 100191, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Conjunctival impression cytology samples

MeSH Terms

Conditions

Dry Eye SyndromesMedullary cystic kidney disease 1

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Hong Qi, PhD

    Peking University Third Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2022

First Posted

November 3, 2022

Study Start

March 1, 2021

Primary Completion

September 2, 2021

Study Completion

September 2, 2021

Last Updated

November 23, 2022

Record last verified: 2022-10

Locations