ConjunctivitisEBV ConjNCT06689397
Investigating Epstein-Barr Virus Associated Conjunctivitis
An observational study of Conjunctivitis and EBV Infection, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Conjunctivitis, EBV Infection
- How many people
- 5 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Oct 2024to 2 Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants will be recruited from Moorfields A\&E. Eligible patients will be identified by a member of the clinical triage team. All eligible patients will be enrolled during the study period.
Who may be able to join
- 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
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Moorfields Eye Hospital NHS Foundation Trust
London, EC1V 2PD
About this study
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.
Read more
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.
- Conditions
- Conjunctivitis, EBV Infection
- Medical subject headings
- Conjunctivitis, Epstein-Barr Virus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants with clinically suspected viral conjunctivitis in which EBV DNA is identified on NAAT.
To confirm the proportion of:
- participants with clinically suspected viral conjunctivitis in which EBV DNA is identified on NAAT.
- EBV NAAT-positive participants who have a new EBV infection versus those with a reactivation of earlier disease.
- participants in whom EBV is confirmed the cause of conjunctivitis on further investigation.
Measured: From enrollment to the end of visit 2 which can occur within up to 7 days from enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start9 Oct 2024
- Primary completion2 Jun 2025 (estimated)
- Study completion2 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConjunctivitisStudies of the same condition, open and under way.
- 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
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06689397
- Sponsor's protocol ID
- LARF1028
- Other IDs
- 342525, 24/YH/0160
- Acronym
- EBV Conj
- Status last verified
- Nov 2024
- First submitted
- 8 Sep 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- 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 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Epstein-Barr Virus Associated Conjunctivitis
- ClinicalTrials.gov ID
- NCT06689397
- Acronym / sponsor ID
- EBV Conj / LARF1028
- Conditions
- Conjunctivitis, EBV Infection
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- 9 Oct 2024 (actual)
- Primary completion
- 2 Jun 2025 (estimated)
- Study completion
- 2 Jun 2025 (estimated)
- First posted
- 14 Nov 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants will be recruited from Moorfields A\&E. Eligible patients will be identified by a member of the clinical triage team. All eligible patients will be enrolled during the study period.
Key inclusion criteria (4 listed)
- Participants shall be considered eligible for inclusion if:
Key exclusion criteria (2 listed)
- • Present with symptoms/signs such that another diagnosis is deemed more likely, for example topical medication-induced conjunctivitis.
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
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.
To confirm the proportion of: * participants with clinically suspected viral conjunctivitis in which EBV DNA is identified on NAAT. * EBV NAAT-positive participants who have a new EBV infection versus those with a reactivation of earlier disease. * participants in whom EBV is confirmed the cause of conjunctivitis on further investigation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- 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.
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 Conjunctivitis and EBV Infection, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.
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 4 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 14 Nov 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 United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
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?
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.). 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 14 Nov 2024.