diagnosis of an external ocular inflammation in which the application of antibiotics is advisable
Conditions
Interventions
Trade Name: CortiBiciron N
Product Name: Corti Biciron N
Pharmaceutical Form: Eye ointment
INN or Proposed INN: Dexamethasone- 21-isonicotinate
Concentration unit: mg/kg milligram(s)/kilogram
Concent
Sponsors
S&K Pharma Schumann und Kohl GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: diagnosis of external ocular inflammation in which the application of antibiotics is advisable; CSS of key signs and symptoms of > 7 (for definition please refer to chapter 6.1.1); aged between 18 and 75 years (inclusive); 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 F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: incapability of understanding the language in which the information for the patient is given; presence or history of drug or alcohol abuse; presence of any malignant disease in the past 5 years; women of childbearing potential who do not use a reliable method of contraception; the patient is a pregnant or breast-feeding woman; participation in a concurrent clinical study or in another study within the past 4 weeks;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore the non-inferiority of Corti Biciron N compared to Dexa-Gentamicin;Secondary Objective: none;Primary end point(s): Change of the clinical sum score (CSS) of key signs and symptoms, assessed at the follow-up visit (V2) after 3-5 days of treatment, as compared to the initiation visit (V1) | — |
Countries
Czech Republic
Outcome results
None listed