Skip to main content
OpenTrials
Completed

NCT Number: NCT00565123

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Centrum Mikrochirurgii Oka Laser

Warsaw, Masovian Voivodeship, 00-131, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

0.5% levofloxacin eye drops

Drug

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

Primary outcomes

  1. The primary efficacy endpoint was the clinical cure.

    Time frame: 7(+-1) days

Secondary outcomes

  1. The secondary efficacy end point was the microbiological eradication.

    Time frame: 7(+-1) days

Sponsors and collaborators

Lead sponsor

Laser Microsurgery Centre, Poland

Other

Collaborators

  • Katedra I Klinika Okulistyki II Wydz. Lek. AM w Warszawie,
  • MedSource Polska
  • University Hospital No 1 Wroclaw

Registry information

Official study 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

Important dates

Study start
2004
Study completion
2006
First posted
Nov 29, 2007
Registry last updated
Nov 29, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.