NCT06621446

Brief Summary

To investigate the prevalence of dry eye in adults in Beijing, and explore the extremely dangerous factors of dry eye in adults in Beijing through two years follow-up, and establish a prediction model of dry eye; On this basis, the prevention and treatment strategy of dry eye disease suitable for Chinese people is put forward, and its actual effect is verified.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

July 15, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 1, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

October 9, 2024

Status Verified

October 1, 2024

Enrollment Period

2 months

First QC Date

September 23, 2024

Last Update Submit

October 7, 2024

Conditions

Dry Eye

Keywords

PrevalenceIncidenceRisk FactorDry EyeAdult

Outcome Measures

Primary Outcomes (1)

  • Incidence of Dry eye

    The incidence of dry eye is the primary outcome, and will be calculated by number of newly developed dry eye cases divided by total number of those who didn\'t have dry eye in last year. The presence of dry eye will be measured relying on the following examinations: questionnaire, tear break-up time examination

    two years

Secondary Outcomes (1)

  • Prevalence of Dry Eye

    one year

Interventions

Comprehensive intervention modelOTHER

A dry eye intervention strategy: including health education, the use of eye drops, and regular review.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This is a population-based study. Study population are residents (adults aged above 18) of sampled communities.

You may qualify if:

  • Aged 18 or above, resident population of sample community, able to complete dry eye examination, informed consent signed

You may not qualify if:

  • Mental illness, mobility difficulties, can not participate in follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing

Beijing, Beijing Municipality, 100005, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tears

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

September 23, 2024

First Posted

October 1, 2024

Study Start

July 15, 2023

Primary Completion

August 31, 2023

Study Completion

August 31, 2025

Last Updated

October 9, 2024

Record last verified: 2024-10

Locations

CN(1)