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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT02254330
Date of registration: 29/09/2014
Prospective Registration: No
Primary sponsor: NicOx
Public title: ADenoVirus Initiative Study in Epidemiology in Spain
Scientific 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
Date of first enrolment: July 2014
Target sample size: 386
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02254330
Study type:  Observational
Study design:   
Phase:  N/A
Countries of recruitment
Spain
Contacts
Name:     Jose Manuel Benitez Del Castillo, MD
Address: 
Telephone:
Email:
Affiliation:  Ocumed Clinica Oftalmologica
Key inclusion & exclusion criteria

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.



Age minimum: 1 Year
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Viral Conjunctivitis
Intervention(s)
Primary Outcome(s)
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)]
Secondary Outcome(s)
Secondary ID(s)
ADVISE Spain
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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