Acute rhinosinusitis
Conditions
Interventions
Trade Name: Kloramfenikol Santen 5mg/ml eye drops, solution
Pharmaceutical Form: Eye drops, solution
Pharmaceutical form of the placebo: Eye drops, solution
Route of administration of the placebo: Ocu
Sponsors
University of Oslo, Faculty of Medicine, Institute of Health and Society
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant is willing and able to give informed consent for participation in the trial. This will include the ability to understand the study information in Norwegian. 2. Male or Female, aged 18 – 64 years. 3. Diagnosed by their GP with probable acute sinusitis, according to usual diagnostic criteria used by the GP, and according to Norwegian guidelines. 4. In the Investigator’s opinion, is able and willing to comply with all trial requirements. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 400 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Chronic sinusitis; symptoms of the current infection must not exceed four weeks. Participants with recurrent sinusitis are eligible, provided they are symptom free between episodes of sinusitis. 2. Patients having had previous sinus surgery. Patients having had only rhinosurgery are eligible. 3. Significant renal or hepatic impairment. 4. Scheduled elective surgery or other procedures requiring general anaesthesia during the trial. 5. Participant with life expectancy of less than 6 months. 6. Female participant who is pregnant, lactating or planning pregnancy during the course of the trial. 7. Patients with any of the following eye conditions: o Eye injury, eye surgery or laser treatment in the previous 6 months o Recurrent bacterial conjunctivitis (more than 2 episodes last 2 years) o Chronic ongoing eye infection or inflammation, including the need of steroid eye drops o Known allergy to any of the IMPs o The use of contact lenses where the patient is not willing or able to uses glasses instead of contact lenses for the IMP treatment period. 5. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial. This includes any condition in which the IMP, the artificial tears used and/or systemic phenoxymethylpenicillin is contraindicated. 8. Participants who have participated in another research trial involving an investigational product in the past 12 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. Does use of antibiotic eye drops have an effect on symptom resolution compared to placebo (artificial tears) eye drops in people with acute sinusitis? 2. Does the use of placebo (artificial tears) eye drops have an effect on symptom resolution compared to usual care in people with acute sinusitis ;Secondary Objective: Does use of antibiotic eye drops have an effect on symptom resolution compared to usual care in people with acute sinusitis. Does use of eye drops lead to a reduction in oral antibiotic use? Does use of eye drops lead to a reduction in oral antibiotic prescription dispensing? Does use of eye drops lead to better disease-specific quality of life at 1 and 2 weeks? Does the use of eye drops lead to better general quality of life at 1 and 2 weeks? Is there a difference in use of concomitant medication? Is there a difference in incidence of adverse effects? ;Primary end point(s): The primary end point is time to symptom resolution, defined as a 30% reduction in time for patients treated with A-Chloramphenicol eye drops compared to placebo, and B-Placebo eye drops compared to usual care. Symptom resolution is defined as the day on which all symptoms on the major symptom score (MSS) have been rated as mild (1) or none (0) for two days in a row;Timepoint(s) of evaluation of this end point: Major Symptom Score will be measured at inclusion (day 0) and every day in a patient diary up until day 28. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The proportion of patients reporting that they consumed one or more doses of systemic antibiotics. The proportion of patients redeeming a prescription for systemic antibiotics. Sino-nasal outcome test (SNOT-25) score. EQ-5D-5L score. Adverse events like nausea, vomiting, diarrhoea, abdominal pain, rash, eye-itching or others recorded in the patient diary ;Timepoint(s) of evaluation of this end point: Daily, in patient diary Registry follow-up (redeeming antibiotic prescription) Days 0, 7, 14 and 28 (SNOT-25 and EQ-5D-5L) | — |
Countries
Norway
Contacts
Public ContactDepartment of General Practice
University of Oslo, Faculty of Medicine, Institute of Health and Society
Outcome results
None listed