E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial |
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
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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) |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the clinical cure on Day 3. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 15 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 15 |
E.8.9.2 | In all countries concerned by the trial days | 0 |