Allergic ConjunctivitisNCT03812952
China Red Eye Study on Allergic Conjunctivitis
An observational study of Allergic Conjunctivitis, run by Sun Yat-sen University at 1 site in China.
Trial summary
This study is the first multi-center cross-sectional study on the diagnosis and misdiagnosis of allergic conjunctivitis in the ophthalmology clinic in China. It provides a clinical basis for the standardized diagnosis and treatment of allergic eye diseases. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Allergic Conjunctivitis
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2018to 31 Dec 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients whose clinical diagnosis is allergic conjunctivitis.
Who may be able to join
- Patients whose clinical diagnosis is allergic conjunctivitis.
Who cannot join
- The investigator believes that there are any unsuitable reasons for participating in the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Ophthalmic Center of Sun yat-sen Universtiy
Guangzhou, Guangdong, 510000
About this study
Official title: Current Status of Diagnosis and Treatment of Allergic Conjunctivitis in Chinese Ophthalmology Clinic
This study is the first multi-center cross-sectional study on the diagnosis and misdiagnosis of allergic conjunctivitis in the ophthalmology clinic in China. It provides a clinical basis for the standardized diagnosis and treatment of allergic eye diseases.
Read the detailed description
Allergic conjunctivitis is a common disease in ophthalmology. The European Allergy Association, Japan, the United States and other countries have clear diagnostic criteria or guidelines for the definition and diagnosis of allergic diseases and allergic conjunctivitis. However, China is currently lacking related guidelines. Allergic conjunctivitis has some of the same symptoms and signs as other infections/non-infectious conjunctival inflammation. When the symptoms and signs are atypical, it is prone to missed diagnosis and misdiagnosis, resulting in prolonged disease duration, drug abuse and waste of medical resources.
The current abuse of antibiotics is considered to be a huge problem in the treatment of ocular surface diseases. A study in our country believes that the rate of misdiagnosis of dry eye is as high as 66.2%, and most of them are misdiagnosed as chronic conjunctivitis, resulting in frequent using a variety of antibiotic eye drops. At present, the misdiagnosis of allergic conjunctivitis and the abuse of antibiotics caused by misdiagnosis in China are still unclear, therefore clinical research is urgently needed. We intend to use this study to understand the status of diagnosis and treatment of allergic conjunctivitis in China, and provide clinical evidence for the standard diagnosis and treatment of allergic eye diseases.
- Conditions
- Allergic Conjunctivitis
- Keywords
- misdiagnose, mistreatment, antibiotics
- Medical subject headings
- Conjunctivitis, Allergic
What is being measured
The primary outcome is the main question the study is designed to answer.
Specific diagnosis of the patients
the investigators record the patients' specific diagnosis (such as seasonal allergic conjunctivitis, perennial allergic conjunctivitis, vernal keratoconjunctivitis，and etc) on questionnaire when the patient come
Measured: Until the study completion, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start1 Aug 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic ConjunctivitisStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaofeng Lin, Sun Yat-sen University
- Investigators
- Xiaofeng Lin, Study chair, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03812952
- Sponsor's protocol ID
- Xiaofeng Lin
- Status last verified
- Jan 2019
- First submitted
- 8 Nov 2018
- Last updated
- 23 Jan 2019
- Results posted
- 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 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Current Status of Diagnosis and Treatment of Allergic Conjunctivitis in Chinese Ophthalmology Clinic
- ClinicalTrials.gov ID
- NCT03812952
- Acronym / sponsor ID
- Xiaofeng Lin
- Conditions
- Allergic Conjunctivitis
- Keywords
- misdiagnose, mistreatment, antibiotics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 23 Jan 2019 (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.
This study is the first multi-center cross-sectional study on the diagnosis and misdiagnosis of allergic conjunctivitis in the ophthalmology clinic in China. It provides a clinical basis for the standardized diagnosis and treatment of allergic eye diseases.
Detailed description
Allergic conjunctivitis is a common disease in ophthalmology. The European Allergy Association, Japan, the United States and other countries have clear diagnostic criteria or guidelines for the definition and diagnosis of allergic diseases and allergic conjunctivitis. However, China is currently lacking related guidelines. Allergic conjunctivitis has some of the same symptoms and signs as other infections/non-infectious conjunctival inflammation. When the symptoms and signs are atypical, it is prone to missed diagnosis and misdiagnosis, resulting in prolonged disease duration, drug abuse and waste of medical resources.
The current abuse of antibiotics is considered to be a huge problem in the treatment of ocular surface diseases. A study in our country believes that the rate of misdiagnosis of dry eye is as high as 66.2%, and most of them are misdiagnosed as chronic conjunctivitis, resulting in frequent using a variety of antibiotic eye drops. At present, the misdiagnosis of allergic conjunctivitis and the abuse of antibiotics caused by misdiagnosis in China are still unclear, therefore clinical research is urgently needed. We intend to use this study to understand the status of diagnosis and treatment of allergic conjunctivitis in China, and provide clinical evidence for the standard diagnosis and treatment of allergic eye diseases.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients whose clinical diagnosis is allergic conjunctivitis.
Key inclusion criteria (1 listed)
- Patients whose clinical diagnosis is allergic conjunctivitis.
Key exclusion criteria (1 listed)
- The investigator believes that there are any unsuitable reasons for participating in the trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Specific diagnosis of the patients
Time frame: Until the study completion, up to 1 year
the investigators record the patients' specific diagnosis (such as seasonal allergic conjunctivitis, perennial allergic conjunctivitis, vernal keratoconjunctivitis，and etc) on questionnaire when the patient come
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
- 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. This study is not recruiting at the moment.
Xiaofeng Lin study chair
Zhongshan Ophthalmic Center, Sun Yat-sen 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 Allergic Conjunctivitis, run by Sun Yat-sen University 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 23 Jan 2019. 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?
Specific diagnosis of the patients (time frame: Until the study completion, up to 1 year). 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 23 Jan 2019.