clinical efficacy and safety of azyter (azythromycin 1,5%) versus tobramycin 0,3% eye drops in the treatment of purulent bacterial conjonctivitis of children.multicenter, international, investigator-masked, randomised, phase IIIB study, parallel comparaison versus reference product, 2 X 111 evaluable patients.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 444

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

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)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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