Viral Conjunctivitis
Conditions
Keywords
Adenoviral conjunctivitis diagnosed with AdenoPlus™ Test
Brief summary
The objectives of this study is to assess the characteristics and frequency of adenovirus conjunctivitis in a population of male and female patients from one year of age who present signs and symptoms of acute conjunctivitis.
Detailed description
Epidemiological, prospective, open, multicentric trial in patients suffering from acute conjunctivitis who will undergo a rapid diagnostic test for adenoviral conjunctivitis at the time of their visit to the ophthalmologist office, at the emergency room or during hospitalization. This epidemiological study will include approximately 500 patients in the United Kingdom. The planned duration of the study is one year from the first patient visit to the last patient visit.
Interventions
None listed
Sponsors
NicOx
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or Female patients of at least one year of age presenting acute (for less than 7 days) conjunctivitis signs and symptoms. * Patient or / and legal representative (if patient below 18 years of age) must be able to provide oral consent for the collection and treatment of the questionnaire data. * No history of hypersensitivity to corn starch, talcum powder or Dacron (sampling fleece components).
Exclusion criteria
* Current use or having received (within the last 7 days) local antiviral therapies such as povidone iodine or ganciclovir, or topical steroids or immunomodulators such as cyclosporine which may interfere with the test result. * Previous enrolment in the present study. * Any direct involvement with the study conduct at site or any family link with study site staff.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of patients with adenovirus conjunctivitis | During the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit) | The percentage of patients with adenovirus conjunctivitis documented by a positive AdenoPlus® test over the tested population of male and female patients who present signs and symptoms of acute conjunctivitis. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Seasonality and geographic repartition observed. | During the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit) | The number of patients with adenovirus conjunctivitis who visited the ophthalmologist in spring, summer, autumn and winter and their geographic area (e.g. by hospital, by area). |
| Clinical profiles of the patients | During the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit) | The percentage of each eye signs and symptoms, the mean duration of the disease for both the patients with positive and negative AdenoPlus® tests, the number or follow-up visit done and the correlation between the initial diagnosis (before AdenoPlus® test results) and the final diagnosis (post AdenoPlus® test results). |
| Resource utilization during the treatment and evaluation of the costs | On day 1: at least once during the single visit to the ophthalmologist and if any also during the follow-up visit(s) | Estimation of resource utilized during course of treatment (use of drugs, number of visits done by the patient…), and associated costs (which would be calculated by applying unit costs to resource use). |
| Patient/parent absenteeism linked to this disease. | On day 1: at least once during the single visit to the ophthalmologist and if any also during the follow-up visit(s) | Number of days out of work and/or out of school linked to this disease. |
| Safety assessment | On day 1: at least once during the single visit to the ophthalmologist and if any also during the follow-up visit(s) | Number of adverse incidents (AIs) and events that are of significant (SEs) reported to Nicox |
Countries
United Kingdom
Outcome results
None listed