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

Information source: Laser Microsurgery Centre, Poland
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bacterial Conjunctivitis

Intervention: 0.5% levofloxacin eye drops (Drug); 0.5% levofloxacin eye drops (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Laser Microsurgery Centre, Poland

Official(s) and/or principal investigator(s):
Jerzy Szaflik, MD,Ph.D., Principal Investigator, Affiliation: Laser Microsurgery Centre; Department of Ophthalmology, Medical University of Warsaw


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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: The primary efficacy endpoint was the clinical cure.

Secondary outcome: The secondary efficacy end point was the microbiological eradication.


Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.


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.

Locations and Contacts

Centrum Mikrochirurgii Oka Laser, Warszawa, Mazowieckie 00-131, Poland
Additional Information

Starting date: September 2004
Last updated: November 28, 2007

Page last updated: August 23, 2015

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