This trial will be performed on children aged from one day of life to 18 years old. The medical conditions that will be observed is the purulent bacterial conjonctivitis.
Conditions
Interventions
Trade Name: AZYTER
Pharmaceutical Form: Eye drops, solution
Trade Name: Tobrex 0,3%
Product Name: Tobramycine
Pharmaceutical Form: Eye drops, solution
Sponsors
Laboratoires Thea
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: patients will be eligible for inclusion in this study if all these criteria are respected: - Age superior than one day life (newborn, infant, child, adult)* and less than 18 years *(definition of new born's age= 0-2 months old) -Ability to provide written informed consent by the patient and his/her legally acceptable representatives (mother and father, or tutor or witness) -Ability to comply with the study-specified visit schedule and procedures -PURULENT BACTERIAL CONJUNCTIVITIS (unilateral or bilateral) defined by the following both cardinal signs in at least one eye: - a rating of at least 1 (grade 1,2 or 3) for conjunctival purulent discharge. AND - a rating of at least 1 (grades 1,2 or 3) for bulbar conjunctival injection Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Ophthalmic non-inclusion criteria (in either eye) - Risk factors of complication: . Diagnosis of bacterial conjunctivitis of more than 7 days at Day 0. . Bacterial infection after trauma or presence of foreign body. . Dacryocystitis. . Corneal ulceration or keratitis. - Other aetiologies of red eyes: . Suspicion of viral conjunctivitis: - Viral epidemic context. - Clinical feature suggestive of viral ocular infection. . Suspicion of closed angle glaucoma crisis. . Suspicion of acute allergy conjunctivitis. -Ocular criteria for ethics purpose: . Presence of clinically significant abnormality in the cornea, iris or anterior/ posterior segment. . Organic amblyopia, monophthalmia. . Vision not correctable to at least 20/100 with the Snellen Chart or the equivalent with another optotype adapted to the age of the child (and usually used by the ophthalmologist department) . Contact lens wearer Systemic/non ophthalmic non-inclusion criteria - Known or suspected hypersensitivity to one of the components of the study medications, or to any other macrolide antibiotic or to test products - Any medical or surgical history, disorder or disease (such as acute or chronic severe organic disease: hepatic, endocrine, neoplasic, haematological; immunosuppressive, infectious diseases [like malaria, AIDS,…], severe psychiatric illness, relevant cardiovascular abnormalities, etc.) and/or any complicating factor or structural abnormality, judged by the investigator to be incompatible with the study. - Newborn not born at term (< 37 weeks of amenorrhea) Specific non-inclusion criteria for women - childbearing potential girl (menstruated girl) who is not using oral contraceptive method Non-inclusion criteria related to general conditions - Inability of patient and/or relatives to understand the study procedures. - Non compliant patient and/or relatives (e.g. not willing to attend the follow-up visits, way of life interfering with compliance). - Participation in another clinical study within the last 3 months. - Already included once in this study. - Patient not covered by the French Social Security scheme (for French patients only). Non-inclusion criteria related to previous and concomitant medications / non-product therapies Patient using any of the following previous and concomitant medication / treatment (according to the described periods) will not be included in the study: -Ocular surgery (12months before inclusion) -Systemic macrolide antibiotic medications (one month before inclusion) -Systemic steriods (2 weeks before inclusion) -Topical ocular macrolide antibiotics, when available in the country (1 week before inclusion) -Topical ocular steroids and /or nonteroidal anti inflammatories (1 week before inclusion) -Topical (ocular, nasal, bronchial, ...) treatment except nasal 0,9% eye drops (1 day before inclusion) -Systemic NSAIDs (1 day before inclusion) -Immunosupressive treatment (till inclusion) -Systemic antibiotic medication (till inclusion)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the efficacy of Azyter, in comparaison to tobramycine eye drops, for the treatment of purulent bacterial conjunctivitis of children aged from one day of life to 18 years old, and to assess the safety. The primary efficacy variable is the CLINICAL CURE on Day 3, in the "worse eye" for patients with Day-0 positive cultures. The clinical outcome will be evaluated on the basis of the two cardinal ocular signs: -a score 0 for bulbar conjunctival injection, -AND a score 0 for conjunctival discharge;Secondary Objective: Clinical efficacy criteria - At Day 3: 1. Clinical improvement with residual conjunctival injection / other at Day 3 for the “worse eye” 2. Clinical status at Day 3 for the “other eye” for “both eye” - At Day 7 ± 1: Clinical status for the “worse eye” Clinical status for the “other eye” Clinical status for “both eyes”. - Ocular signs and symptoms: - Judgement on the global efficacy by the investigator Bacteriological efficacy: - Bacterial outcome (resolved/not resolved) Ocular and systemic safety ;Primary end point(s): The primary endpoint is the clinical cure on Day 3. | — |
Countries
Belgium, France, Germany, Portugal, Spain
Outcome results
None listed