- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06689397
Investigating Epstein-Barr Virus Associated Conjunctivitis (EBV Conj)
Conjunctivitis means inflammation of the conjunctiva, the thin transparent layer over the white of the eye and under the eyelids. Acute conjunctivitis caused by infection is the most common condition seen in ophthalmic emergency departments, accounting for up to 10% of cases. It is responsible for 41% of eye-related general practice consultations. A diagnosis is usually made on the patient's symptoms and signs, despite this being less reliable than laboratory testing. When a cause is found, it is usually a common cold virus called adenovirus, that gets better with time and does not require treatment.
Through investigating cases of conjunctivitis at Moorfields, it has been discovered that in addition to adenovirus, Epstein Barr virus (EBV) is sometimes detected in conjunctival swabs from individuals with conjunctivitis. EBV is a very common viral infection that 95% of adults have experienced. EBV infection mostly passes unnoticed but when symptoms do occur, they include a sore throat, high temperature, swollen glands and tiredness, often called glandular fever or infectious mononucleosis. Conjunctivitis can also occur. EBV remains in the body after infection and rarely causes further problems. The virus can become active again occasionally, which is known as reactivation.
Reactivation usually passes unnoticed but sometimes is associated with recurrence of symptoms. It is possible that reactivation may cause conjunctivitis. It is not certain, which is will be observed as a part of this study, as it might be the cause of some of the conjunctivitis seen.
Through a collaboration with University College London (UCL), the aim is to gain further insight into infectious conjunctivitis, particularly in relation to EBV. This will be done by taking a swab of the conjunctiva, a single blood test and a tiny (1-2mm) tissue sample from the inner eyelid. Improved knowledge will allow the research team to develop better guidance and treatment for patients with conjunctivitis.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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London, United Kingdom, EC1V 2PD
- Moorfields Eye Hospital NHS Foundation Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Participants shall be considered eligible for inclusion if:
- Aged ≥16 years;
- working diagnosis of infective (viral) follicular conjunctivitis (<4 weeks duration)
- EBV positive conjunctival swab
Exclusion Criteria:
• Present with symptoms/signs such that another diagnosis is deemed more likely, for example topical medication-induced conjunctivitis.
- Participant declines diagnostic tests or appropriate corneal or conjunctival sample(s) not obtained for any reason
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The number of participants with clinically suspected viral conjunctivitis in which EBV DNA is identified on NAAT.
Time Frame: From enrollment to the end of visit 2 which can occur within up to 7 days from enrollment.
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To confirm the proportion of:
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From enrollment to the end of visit 2 which can occur within up to 7 days from enrollment.
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LARF1028
- 342525 (Other Identifier: IRAS)
- 24/YH/0160 (Other Identifier: Research Ethics Committee)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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