ADenoVirus Initiative Study in Epidemiology in Spain

NicOx

Status: Completed

Conditions: Viral Conjunctivitis

Study type: Observational

Funder types: Industry

Identifiers

NCT02254330

ADVISE Spain

Details and patient eligibility

About

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.

Full 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 Spain. The planned duration of the study is one year from the first patient visit to the last patient visit.

Enrollment: 386 patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

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.