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

This study has been completed.
Katedra I Klinika Okulistyki II Wydz. Lek. AM w Warszawie,
University Hospital No 1 Wroclaw
MedSource Polska
Information provided by:
Laser Microsurgery Centre, Poland Identifier:
First received: November 27, 2007
Last updated: November 28, 2007
Last verified: November 2007
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.

Condition Intervention Phase
Bacterial Conjunctivitis Drug: 0.5% levofloxacin eye drops Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Laser Microsurgery Centre, Poland:

Primary Outcome Measures:
  • The primary efficacy endpoint was the clinical cure. [ Time Frame: 7(+-1) days ]

Secondary Outcome Measures:
  • The secondary efficacy end point was the microbiological eradication. [ Time Frame: 7(+-1) days ]

Enrollment: 119
Study Start Date: September 2004
Study Completion Date: January 2006
Arms Assigned Interventions
Experimental: Group A
Experimental dosage
Drug: 0.5% levofloxacin eye drops
0.5% levofloxacin eye drops three times daily to each eye for 5 days
Active Comparator: Group B
Classical dosage
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)


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00565123

Centrum Mikrochirurgii Oka Laser
Warszawa, Mazowieckie, Poland, 00-131
Sponsors and Collaborators
Laser Microsurgery Centre, Poland
Katedra I Klinika Okulistyki II Wydz. Lek. AM w Warszawie,
University Hospital No 1 Wroclaw
MedSource Polska
Principal Investigator: Jerzy Szaflik, MD,Ph.D. Laser Microsurgery Centre; Department of Ophthalmology, Medical University of Warsaw
  More Information Identifier: NCT00565123     History of Changes
Other Study ID Numbers: LF- 12/2003
Study First Received: November 27, 2007
Last Updated: November 28, 2007

Keywords provided by Laser Microsurgery Centre, Poland:
bacterial conjunctivitis levofloxacin fluoroquinolone

Additional relevant MeSH terms:
Conjunctivitis, Bacterial
Conjunctival Diseases
Eye Diseases
Eye Infections, Bacterial
Bacterial Infections
Eye Infections
Ophthalmic Solutions
Pharmaceutical Solutions
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors processed this record on September 20, 2017