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

Last updated: November 28, 2007
Sponsor: Laser Microsurgery Centre, Poland
Overall Status: Completed

Phase

2/3

Condition

Bacterial Conjunctivitis

Allergy

Eye Disorders/infections

Treatment

N/A

Clinical Study ID

NCT00565123
LF- 12/2003
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 conjunctivalinjection)

  • Patients who have given and signed informed consent

  • The ability and willingness to comply with all study procedures

Exclusion

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, immunosupressivetherapy, if these treatments have not stopped at least 3 months prior to the start ofthe study;

  • Concurrent use of non- steriodal anti- inflammatory drugs (NSAIDs), with the exceptionof low- dose aspirin. (see par. 11.5)

  • Prior and concurrent systemic antibiotic treatment during last 7 days before thebeginning the study.(see par. 11.5)

  • Concurrent other eye drops

  • All ocular surgeries which were performed less than 6 months before the beginning ofthe study.

  • Any clinical condition, which, in the opinion of the investigator would not allow safecompletion of the protocol.

  • History of any malignancy within the past 5 years prior to study entry, except basalcell 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

Total Participants: 119
Study Start date:
September 01, 2004
Estimated Completion Date:
January 31, 2006

Connect with a study center

  • Centrum Mikrochirurgii Oka Laser

    Warszawa, Mazowieckie 00-131
    Poland

    Site Not Available

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