Comparison of efficacy and safety of two drugs in patients with acute conjunctivitis caused by bacteria.

• Conditions: Acute Bacterial Conjunctivitis; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2012-003664-41-BG
• Lead Sponsor: Balkanpharma-Razgrad AD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-16
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- 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

Exclusion Criteria

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified