Study of Efficacy of Levofloxacin 0.5% Ophthalmic Solution Administered Three Times a Day for Bacterial Conjunctivitis

A Single- Centre, Randomised Study Of The Clinical And Microbiological Efficacy Of Decreasing The Dosage Of Levofloxacin 0,5% Eye Drops As Compared To Standard Eye Drop Dosage In Patients With Bacterial Conjunctivitis

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00565123

Enrollment

119

Registered

2007-11-29

Start date

2004-09-30

Completion date

2006-01-31

Last updated

2007-11-29

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

Conditions

Bacterial Conjunctivitis

Keywords

bacterial conjunctivitis levofloxacin fluoroquinolone

Brief summary

The aim of the study is to evaluate the clinical and microbiological efficacies of three times daily administration of levofloxacin 0,5% eye drops as compared to the more frequent dosing (up to 8 times a day during the first 2 days and up to 4 times a day during the next 3 days) in patients with bacterial conjunctivitis.

Interventions

DRUG0.5% levofloxacin eye drops

0.5% levofloxacin eye drops three times daily to each eye for 5 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Male and female patients between 18 and 70 years of age * Patients with Conjunctivitis (defined as the presence of three cardinal signs: conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection) * Patients who have given and signed informed consent * The ability and willingness to comply with all study procedures

Exclusion criteria

* Insulin Dependent Diabetes Mellitus (IDDM) * Patients with keratitis or hordeolum * Glaucoma * Sjogren's Syndrom and Sick Eye's Syndrom. * Ectropion, entropion; * Using contact lenses during the study * Poor visual acuity in the other eye * Prior and concurrent concomitant treatment glycocorticosteroids, immunosupressive therapy, if these treatments have not stopped at least 3 months prior to the start of the study; * Concurrent use of non- steriodal anti- inflammatory drugs (NSAIDs), with the exception of low- dose aspirin. (see par. 11.5) * Prior and concurrent systemic antibiotic treatment during last 7 days before the beginning the study.(see par. 11.5) * Concurrent other eye drops * All ocular surgeries which were performed less than 6 months before the beginning of the study. * Any clinical condition, which, in the opinion of the investigator would not allow safe completion of the protocol. * History of any malignancy within the past 5 years prior to study entry, except basal cell or squamous cell skin carcinoma. * Hypersensitivity to fluoroquinolons and benzalkonium chloride; * Intended or ascertained pregnancy or lactation; * Participation in a clinical trial within last 30 days.

Design outcomes

Primary

Measure	Time frame
The primary efficacy endpoint was the clinical cure.	7(+-1) days

Secondary

Measure	Time frame
The secondary efficacy end point was the microbiological eradication.	7(+-1) days

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026