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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-003664-41-BG
Enrollment
Unknown
Registered
2013-01-16
Start date
2013-07-04
Completion date
Unknown
Last updated
2014-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Bacterial Conjunctivitis

Interventions

Trade Name: LEVOFLOXAN eye drops, solution, 5 ml Pharmaceutical Form: Eye drops, solution INN or Proposed INN: LEVOFLOXACIN CAS Number: 100986-85-4 Concentration unit: mg/ml milligram(s)/millilitre Co

Sponsors

Balkanpharma-Razgrad AD
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: - Age 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

Design outcomes

Primary

MeasureTime frame
Main Objective: - Evaluation of therapeutically effect of Levofloxan 0,5% eye drops in patients with Acute Bacterial Conjunctivitis. - Comparative evaluation of efficacy of Levofloxan 0,5% eye drops with respect to the comparator ;Secondary Objective: - Evaluation of tolerability and safety of Levofloxan 0,5% eye drops - Comparative evaluation of tolerability and safety of Levofloxan 0,5% eye drops with respect to the comparator ;Primary end point(s): Microbiological finding, eradication rate, biomicroscopy data;Timepoint(s) of evaluation of this end point: Visit 1, Visit 3—

Secondary

MeasureTime frame
Secondary end point(s): Clinical symptoms (redness, irritation, itching, feeling presence of foreign body, secretion, photosensitivity);Timepoint(s) of evaluation of this end point: ?????? 1, ?????? 2, ?????? 3—

Countries

Bulgaria

Contacts

Public ContactResearch and Development

Balkanpharma-Razgrad AD

office@razgrad.bg+35984613303

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026