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

NCT00565123 | Completed Phase 2

• 1 other identifier: LF- 12/2003
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The primary efficacy endpoint was the clinical cure.

  7(+-1) days

Secondary Outcomes (1)

• The secondary efficacy end point was the microbiological eradication.

  7(+-1) days

Study Arms (2)

Group A

EXPERIMENTAL

Experimental dosage

Drug: 0.5% levofloxacin eye drops

Group B

ACTIVE COMPARATOR

Classical dosage

Drug: 0.5% levofloxacin eye drops

Interventions

0.5% levofloxacin eye drops DRUG

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

Group A

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Laser Microsurgery Centre, Poland: lead
• Katedra I Klinika Okulistyki II Wydz. Lek. AM w Warszawie,: collaborator
• University Hospital No 1 Wroclaw: collaborator
• MedSource Polska: collaborator

Study Sites (1)

Centrum Mikrochirurgii Oka Laser

Warsaw, Masovian Voivodeship, 00-131, Poland

Location

MeSH Terms

Conditions

Conjunctivitis, Bacterial

Condition Hierarchy (Ancestors)

Eye Infections, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Eye Infections; Conjunctivitis; Conjunctival Diseases; Eye Diseases

Study Officials

• Jerzy Szaflik, MD,Ph.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 27, 2007
• First Posted: November 29, 2007
• Study Start: September 1, 2004
• Study Completion: January 1, 2006
• Last Updated: November 29, 2007

Record last verified: 2007-11

Locations

PL (1)