A multicenter, double-blind, randomized, parallel arm comparative study for the assessment of the safety and efficacy of azidamfenicol eye drops (Thilocof®/FARMEX) versus tobramycine eye drops (?obrex®/Alcon) in the treatment of patients with infections of the outer layers of the eye.

FARMEX SA0 个研究点开始时间: 2013年5月22日最近更新: 2013年6月3日

试验速览

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•1.Men and women, of = or > 18 years of age
•2.Subjects with a clinical diagnosis of outer eye layer(s) infection (i.e. subjects with a diagnosis of bacterial conjuctivitis, cornea-conjuctivitis, blepharitis or blepharo-conjuctivitis)
•3.Subjects who present conjuctival hyperemia and at least one of the following signs:
•purulent of mucopurulent exudate,
•formation of scabs on eyelashes
•redness & thickness of the free eyelash rim
•eyelashes loss (of various degree)
•4.Subjects willing to and capable of attending the study visits within the visits' allowed time windows.
•5.Subjects who have signed the Informed Consent.
•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 100
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•1.Patients aged <18 years
•2.Patients who present with symptoms for more than 7 days
•3.Patients with typical signs and/or symptoms of chlamydia, viral or fungal infection
•4.Patients with an inflammation of allergic aetiology .
•5.Patients with severe systemic infections
•6.Patients receiving systemic antimicrobial treatment
•7.Patients who underwent treatment with topical, ophthalmic antimicrobial or steroid medications during the last two weeks before their enrollment in the study.
•8.Patients who underwent an ophthalmic surgery during the last 3 months before their enrollment in the study
•9.Patients suffering from other ophthalmic diseases that may interfere with the outcomes of this study.
•10.Patients with a history of severe allergy or known hypersensitivity to the study drugs or known hypersensitivity to any of the study drugs components, especially patients with a history of blood dyscrasias or patients who presented with bone marrow suppression following the administration of azidamfenicol eye drops solution
•11.Pregnant of breast-feeding women.
•12.Women of child-bearing potential who do not use adequate contraceptive measures.
•13.Patients who, according the the investigator's opinion, are unlikely to comply with the study protocol or who are incapable to participate for any other reason or who do not wish to sign the Informed Consent form .

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