ADenoVirus Initiative Study in Epidemiology in Spain
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|ClinicalTrials.gov Identifier: NCT02254330|
Recruitment Status : Completed
First Posted : October 1, 2014
Last Update Posted : January 10, 2017
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||386 participants|
|Official Title:||Epidemiological, Prospective, Multicentric, Open Study To Assess The Characteristics And Frequency Of Adenoviral Conjunctivitis As Diagnosed With The Point Of Care AdenoPlus® Test In Patients Suffering From Acute Conjunctivitis|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2015|
- Frequency of patients with adenovirus conjunctivitis [ Time Frame: 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.
- Seasonality and geographic repartition observed. [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02254330
|Instituto de Microcirugía Ocular|
|Instituto Clínico Quirúrgico de Oftalmología|
|Alcazar de San Juan|
|Ciudad Real, Spain|
|Hospital La Arruzafa|
|Ocumed Clinica Oftalmologica|
|Madrid, Spain, 28023|
|Fundacion Jimenez Diaz|
|Hospital Clinico San Carlos|
|Hospital de Villalba|
|Hospital Infanta Leonor-Vallecas|
|Hospital La Paz|
|Hospital Ramon Y Cajal|
|Instituto Oftalmologico Fernandez-Vega|
|Clinica Universitaria de Navarra|
|Hospital Clinico Santiago de Compostela|
|Santiago de Compostela, Spain|
|Hospital Universitario de Canarias|
|Hospital La Fe|
|Hospital Clinico de Valladolid|
|Instituto Oftalmobiologia Aplicada|
|Hospital de Cruces, Baracaldo|
|Principal Investigator:||Jose Manuel Benitez Del Castillo, MD||Ocumed Clinica Oftalmologica|