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

This study has been completed.
Sponsor:
Collaborators:
Katedra I Klinika Okulistyki II Wydz. Lek. AM w Warszawie,
University Hospital No 1 Wroclaw
MedSource Polska
Information provided by:
Laser Microsurgery Centre, Poland
ClinicalTrials.gov Identifier:
NCT00565123
First received: November 27, 2007
Last updated: November 28, 2007
Last verified: November 2007

November 27, 2007
November 28, 2007
September 2004
Not Provided
The primary efficacy endpoint was the clinical cure. [ Time Frame: 7(+-1) days ]
Same as current
Complete list of historical versions of study NCT00565123 on ClinicalTrials.gov Archive Site
The secondary efficacy end point was the microbiological eradication. [ Time Frame: 7(+-1) days ]
Same as current
Not Provided
Not Provided
 
Study of Efficacy of Levofloxacin 0.5% Ophthalmic Solution Administered Three Times a Day for Bacterial Conjunctivitis
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

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Bacterial Conjunctivitis
  • Drug: 0.5% levofloxacin eye drops
    0.5% levofloxacin eye drops three times daily to each eye for 5 days
  • 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)
  • Experimental: Group A
    Experimental dosage
    Intervention: Drug: 0.5% levofloxacin eye drops
  • Active Comparator: Group B
    Classical dosage
    Intervention: Drug: 0.5% levofloxacin eye drops
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
119
January 2006
Not Provided

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Poland
 
NCT00565123
LF- 12/2003
No
Not Provided
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
Laser Microsurgery Centre, Poland
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP