Dry EyeADECNCT06621446
The Beijing Adult Dry Eye Cohort Study
An observational study of Dry Eye, run by Beijing Tongren Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- Comprehensive intervention model
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2023to 31 Aug 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This is a population-based study. Study population are residents (adults aged above 18) of sampled communities.
Who may be able to join
- Aged 18 or above, resident population of sample community, able to complete dry eye examination, informed consent signed
Who cannot join
- Mental illness, mobility difficulties, can not participate in follow-up
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Specifically, it is planned to carry out cluster random sampling in Jianguomen community, Yongdingmenwai community, and Jiaodaokou community in Dongcheng District, Beijing, and select adults over the age of 18 to enter the queue for observation; In order to ensure the accuracy of the prevalence survey, people with mobility difficulties or mental problems are not excluded. The subjects will be examined by ophthalmology and OSDI questionnaire to determine whether these people have dry eyes. Then the prevalence of dry eye would be expolored. Then through one-year and two-year follow-up, the incidence would be explored.
- Conditions
- Dry Eye
- Being tested
- Comprehensive intervention model
- Keywords
- Prevalence, Incidence, Risk Factor, Dry Eye, Adult
- 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.
Comprehensive intervention modelOther
A dry eye intervention strategy: including health education, the use of eye drops, and regular review.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: two years
Secondary outcomes (1)
Prevalence of Dry Eye
The prevalence of dry eye is the secondary outcome. The prevalence will be defined as number of dry eye cases, divided by total participants. Dry eye will be measured relying on questionnaire and tear break-up time examination.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start15 Jul 2023
- Primary completion31 Aug 2023
- Study completion31 Aug 2025 (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.
- More trials run by Beijing Tongren HospitalThe sponsor's other registered studies.
- 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
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Jie, MD, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06621446
- Sponsor's protocol ID
- BeijingTH TREC2024-KY084
- Other IDs
- Xue Ke Dai Tou Ren-02-22, Xue Ke Dai Tou Ren-02-22
- Acronym
- ADEC
- Status last verified
- Oct 2024
- First submitted
- 23 Sep 2024
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Beijing Adult Dry Eye Cohort Study
- ClinicalTrials.gov ID
- NCT06621446
- Acronym / sponsor ID
- ADEC / BeijingTH TREC2024-KY084
- Conditions
- Dry Eye
- Keywords
- Prevalence, Incidence, Risk Factor, Dry Eye, Adult
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 1 Oct 2024 (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.
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.
Detailed description
Specifically, it is planned to carry out cluster random sampling in Jianguomen community, Yongdingmenwai community, and Jiaodaokou community in Dongcheng District, Beijing, and select adults over the age of 18 to enter the queue for observation; In order to ensure the accuracy of the prevalence survey, people with mobility difficulties or mental problems are not excluded. The subjects will be examined by ophthalmology and OSDI questionnaire to determine whether these people have dry eyes. Then the prevalence of dry eye would be expolored. Then through one-year and two-year follow-up, the incidence would be explored.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This is a population-based study. Study population are residents (adults aged above 18) of sampled communities.
Key inclusion criteria (1 listed)
- Aged 18 or above, resident population of sample community, able to complete dry eye examination, informed consent signed
Key exclusion criteria (1 listed)
- Mental illness, mobility difficulties, can not participate in follow-up
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 |
|---|---|---|
| Comprehensive intervention modelA dry eye intervention strategy: including health education, the use of eye drops, and regular review. | Other | – |
Primary outcome
Incidence of Dry eye
Time frame: two years
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
1 secondary outcome
Prevalence of Dry Eye
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Beijing Tongren 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 1 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 9 Oct 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dry eye (time frame: two years). 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 9 Oct 2024.