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.

aboratoires Thea0 个研究点目标入组 444 人开始时间: 2009年4月2日最近更新: 2015年3月30日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 444

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•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

排除标准

•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)

研究者

发起方

aboratoires Thea

相似试验

进行中（未招募）

1 期

EUCTR2008-003567-39-FRaboratoires Thea444

进行中（未招募）

不适用

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 comparison versus reference product, 2 X 111 evaluable patients.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 conjunctivitis.

EUCTR2008-003567-39-DEaboratoires Thea444

进行中（未招募）

不适用

EUCTR2008-003567-39-BEaboratoires Thea444

进行中（未招募）

不适用

Efficacy and Safety Assessment of Azyter® (T1225) in Peri-Operative Antibio-Prophylaxis (ocular surface decontamination) for Cataract SurgeryPeri-Operative Antibio-Prophylaxis (ocular surface decontamination) for Cataract SurgeryMedDRA version: 9.1Level: PTClassification code 10064736Term: <Manually entered code. Term in E.1.1>

EUCTR2007-006228-36-FRaboratoires Théa75

已完成

不适用

Efficacy and Safety Assessment of Azyter® (T1225) in Peri-Operative Antibio-Prophylaxis (ocular surface decontamination) for Cataract Surgery

ISRCTN41154297aboratoires Thea (France)75