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

NCT ID: NCT00565123

Last Updated: 2007-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2006-01-31

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.

Conditions

Bacterial Conjunctivitis

Keywords

bacterial conjunctivitis levofloxacin fluoroquinolone

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A

Experimental dosage

Group Type: EXPERIMENTAL

0.5% levofloxacin eye drops

Intervention Type: DRUG

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

Group B

Classical dosage

Group Type: ACTIVE_COMPARATOR

0.5% levofloxacin eye drops

Intervention Type: DRUG

0.5% levofloxacin eye drops 2 hours on days 1 and 2, and then every 4 hours on days 3-5 (up to 4 times per day)

Interventions

0.5% levofloxacin eye drops

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

Intervention Type: DRUG

0.5% levofloxacin eye drops

0.5% levofloxacin eye drops 2 hours on days 1 and 2, and then every 4 hours on days 3-5 (up to 4 times per day)

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Katedra I Klinika Okulistyki II Wydz. Lek. AM w Warszawie,

UNKNOWN

Sponsor Role: collaborator

University Hospital No 1 Wroclaw

OTHER

Sponsor Role: collaborator

MedSource Polska

INDUSTRY

Sponsor Role: collaborator

Laser Microsurgery Centre, Poland

OTHER

Sponsor Role: lead

Principal Investigators

Jerzy Szaflik, MD,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Laser Microsurgery Centre; Department of Ophthalmology, Medical University of Warsaw

Locations

Centrum Mikrochirurgii Oka Laser

Warsaw, Masovian Voivodeship, Poland

Countries

Poland

Other Identifiers

LF- 12/2003

Identifier Type: -

Identifier Source: org_study_id