NCT06689397

Brief 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. 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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

October 9, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 14, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2025

Completed
Last Updated

November 14, 2024

Status Verified

November 1, 2024

Enrollment Period

8 months

First QC Date

September 8, 2024

Last Update Submit

November 13, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    From enrollment to the end of visit 2 which can occur within up to 7 days from enrollment.

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Aged ≥16 years;
  • working diagnosis of infective (viral) follicular conjunctivitis (\<4 weeks duration)
  • EBV positive conjunctival swab

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moorfields Eye Hospital NHS Foundation Trust

London, EC1V 2PD, United Kingdom

Location

MeSH Terms

Conditions

ConjunctivitisEpstein-Barr Virus Infections

Condition Hierarchy (Ancestors)

Conjunctival DiseasesEye DiseasesHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus Infections

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2024

First Posted

November 14, 2024

Study Start

October 9, 2024

Primary Completion

June 2, 2025

Study Completion

June 2, 2025

Last Updated

November 14, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations