ADenoVirus Initiative Study in Epidemiology in Spain

Completed

• Conditions: Viral Conjunctivitis

• Registration Number: NCT02254330
• Lead Sponsor: NicOx

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

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-09-29
• Study First Submitted QC: 2014-09-29
• Study First Posted: 2014-10-01
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-09
• Last Update Posted: 2017-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 386

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (25)

Instituto de Microcirugía Ocular; 🇪🇸 Barcelona, Spain

Clinica Barraquer; 🇪🇸 Barcelona, Spain

Hospital La Paz; 🇪🇸 Madrid, Spain

Hospital La Arruzafa; 🇪🇸 Córdoba, Spain

Ocumed Clinica Oftalmologica; 🇪🇸 Madrid, Spain

Fundacion Jimenez Diaz; 🇪🇸 Madrid, Spain

Hospital Clinico; 🇪🇸 Valencia, Spain

Hospital Ramon Y Cajal; 🇪🇸 Madrid, Spain

Hospital La Fe; 🇪🇸 Valencia, Spain

Instituto Clínico Quirúrgico de Oftalmología; 🇪🇸 Bilbao, Spain

Hospital de Villalba; 🇪🇸 Madrid, Spain

Hospital Infanta Leonor-Vallecas; 🇪🇸 Madrid, Spain

Hospital Quiron; 🇪🇸 Madrid, Spain

Instituto Oftalmologico Fernandez-Vega; 🇪🇸 Oviedo, Spain

Clinica Universitaria de Navarra; 🇪🇸 Pamplona, Spain

Hospital Universitario de Canarias; 🇪🇸 Tenerife, Spain

Hospital Clinico Santiago de Compostela; 🇪🇸 Santiago de Compostela, Spain

Hospital Clinico de Valladolid; 🇪🇸 Valladolid, Spain

Instituto Oftalmobiologia Aplicada; 🇪🇸 Valladolid, Spain

Hospital Torrejon; 🇪🇸 Madrid, Spain

VISSUM; 🇪🇸 Alicante, Spain

Hospital Clinic; 🇪🇸 Barcelona, Spain

Alcazar de San Juan; 🇪🇸 Ciudad Real, Spain

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain

Hospital de Cruces, Baracaldo; 🇪🇸 Vizcaya, Spain