An observational study in Viral Conjunctivitis, sponsored by NicOx. Completed at 13 sites in Germany. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2017-01-11.
Sponsored by NicOx · Observational
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 Germany. The planned duration of the study is one year from the first patient visit to the last patient visit.
361 studies on the registry are indexed under Conjunctivitis; 17 are open to participants now.
This study's enrollment of 240 is above the median of 152 across 47 observational studies indexed under Conjunctivitis.
Browse Conjunctivitis studies →NicOx is the lead sponsor of 15 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
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.
Time frame: During the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit)
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).
Time frame: During the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit)
Clinical profiles of the patients
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).
Time frame: 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 and evaluation of the costs
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).
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)
Patient/parent absenteeism linked to this disease.
Number of days out of work and/or out of school 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)
Safety assessment
Number of adverse incidents (AIs) and events that are of significant (SEs) reported to Nicox
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)
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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Conjunctivitis, Viral
NicOx