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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.
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 Italy. The planned duration of the study is one year from the first patient visit to the last patient visit.
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| Measure | Description | Time Frame |
|---|---|---|
| Frequency of patients with adenovirus conjunctivitis | 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. | During the visit to the ophthalmologist (one visit) |
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| Measure | Description | Time Frame |
|---|---|---|
| data collection: Seasonality and geographic repartition observed. | 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). | One day during the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit) |
Inclusion Criteria:
Exclusion Criteria:
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Any female and male patients from one year of age with signs and symptoms of acute conjunctivitis either seen during ophthalmology consultations or who are in the emergency room or hospitalized, can be enrolled in the study
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| Name | Affiliation | Role |
|---|---|---|
| Paolo Fogagnolo, MD | Ospedale san Paolo Blocco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica oculistica / Ospedale san Paolo | Milan | 85 20142 | Italy |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 7, 2017 | |
| Reset | Apr 18, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 7, 2017 | Apr 18, 2017 |
| ID | Term |
|---|---|
| D003236 | Conjunctivitis, Viral |
| ID | Term |
|---|---|
| D015828 | Eye Infections, Viral |
| D015817 | Eye Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
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| Percentage of each eye signs and symptoms measured by questionnaire | The percentage of each eye signs and symptoms for both the patients with positive and negative AdenoPlus® tests | One day during the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit) |
| Duration of the disease measured by questionnaire | the mean duration of the disease for both the patients with positive and negative AdenoPlus® tests | One day during the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit) |
| Number of follow-up visits done measured by questionnaire | The number or follow-up visit done | One day during the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit) |
| Diagnosis measured by questionnaire | The correlation between the initial diagnosis (before AdenoPlus® test results) and the final diagnosis (post AdenoPlus® test results). | One day during the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit) |
| Resource utilization during the treatment | Estimation of resource utilized during course of treatment (use of drugs, number of visits done by the patient…), . | On day 1: at least once during the single visit to the ophthalmologist and if any also during the follow-up visit(s) at latest one year following visit 1 |
| Evaluation of the costs of resource utilization during the treatment | associated costs of resources used during the treatment (use of drugs, number of visits done by the patient…), (which would be calculated by applying unit costs to resource use). | On day 1: at least once during the single visit to the ophthalmologist and if any also during the follow-up visit(s) at latest one year following visit 1 |
| Patient/parent absenteeism linked to this disease measured by questionnaire | Number of days out of work and/or out of school 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) at latest one year following visit 1 |
| Safety assessment measured by data collection | Number of adverse incidents (AIs) and events that are of significant (SEs) reported to Nicox | On day 1: at least once during the single visit to the ophthalmologist and if any also during the follow-up visit(s) at latest one year following visit 1 |
| D003231 |
| Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |