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

Bacterial Conjunctivitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00565123
• Other study ID #: LF- 12/2003
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 27, 2007
• Last updated: November 28, 2007
• Start date: September 2004
• Est. completion date: January 2006

Study information

• Verified date: November 2007
• Source: Laser Microsurgery Centre, Poland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Bacterial Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Bacterial

Intervention

Drug:
• 0.5% levofloxacin eye drops
0.5% levofloxacin eye drops three times daily to each eye for 5 days
• 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)

Locations

Country	Name	City	State
Poland	Centrum Mikrochirurgii Oka Laser	Warszawa	Mazowieckie

Sponsors (4)

Lead Sponsor	Collaborator
Laser Microsurgery Centre, Poland	Katedra I Klinika Okulistyki II Wydz. Lek. AM w Warszawie,, MedSource Polska, University Hospital No 1 Wroclaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy endpoint was the clinical cure.		7(+-1) days
Secondary	The secondary efficacy end point was the microbiological eradication.		7(+-1) days