Open-labeled, randomized, comparative clinical study of efficacy and safety of Levofloxan 0,5% eye drops in patients with Acute Bacterial Conjunctivitis.

Balkanpharma-Razgrad AD0 个研究点开始时间: 2013年1月16日最近更新: 2014年10月7日

适应症

试验速览

暂无简介。

•- Men and women between 18 and 70 years
•- Acute Bacterial Conjunctivitis affecting one or both eyes, determined microbiologicaly and by biomicroscopy
•- Microbiologicaly proven cause sensitive to the action of Levofloxacin
•- Patient is willing to participate and sign an 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 70
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•- Age <18 and > 70
•- Non bacterial Conjunctivitis
•- Bacterial Conjunctivitis lasting more than 3 days
•- Bacterial Conjunctivitis that excludes Levofloxacin monotherapy
•- Superficial infections of the eye, excl. of bacterial conjunctivitis and those due to trauma, presence of foreign body or from wearing contact lenses
•- Corneal inflammation – keratitis, corneal ulcers
•- Hypersensitivity to levofloxacin – other quinolones and/or any of excipients of investigational medicinal products
•- Treatment with systemic quinolones in 30 days before study and/or systemic corticosteroids in 14 days before or during the trial
•- Treatment with NSAIDs, corticosteroids or quinolones for ocular use 7 days before the trial
•- Participation in other clinical trial related to application of antibacterial drugs, NSAIDs and corticosteroids
•- Pregnancy and nursing
•- Result of microbiological examination showing insensitive to levofloxacin cause
•- Occurrence of hypersensitivity reactions
•- Lack of effect on the clinical condition after 3 - 4 days of treatment (visit 2)
•- Refuses to sign informed consent form
•- Non compliance with the protocol
•- Discretion of the principal investigator
•- Occurrence of circumstances unrelated to participation in the trial (eg change of residence

发起方

Balkanpharma-Razgrad AD