Comparative Study in the Efficacy of Topical Besifloxocin With Erythromycin for the Management of Acute Blepharitis

Overview

This study looks at the improvements in signs and symptoms in patients with inflammation of the lids, blepharitis, using two different FDA approved topical antibiotic agents, Besifloxocin and Erythromycin. It also evaluates the bacterial cultures in these patients for microbiologic evidence of improvement.

Full Title of Study: “A Comparative Study in the Clinical and Microbial Efficacy of Topical Besifloxocin Ophthalmic Suspension 0.6% With Erythromycin Ophthalmic Ointment 0.5% BID for the Management of Acute Blepharitis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2011

Detailed Description

This is a pilot project involving thirty patients with a specific form of inflammtion of the lids called anterior blepharitis. The patients are graded for their signs a symptoms and then randomized to receive either topical Besifloxocin or Erythromycin in addition to standard lid hygiene measures. All patients have cultures of their eyelids performed prior to initiating therapy and are followed for four weeks. The antibiotics are used for two weeks following which repeat cultures of the lids are obtained. The patients are followed for one additional week to ensure that there is no recurrence of their symptoms once the antibiotics are discontinued. Only adult patients (age 18-100)and women who are not of child bearing potential are included in this study. Then patients have to have symptoms and signs of the disease, blepharitis. Patient who are on unstable antibiotic or steroid regimens and those who cannot discontinue contact lens use are not included in this study.

Interventions

  • Drug: Erythromycin
    • Topical erythromycin ointment twice a day
  • Drug: Besifloxocin
    • Topical Besifloxocin twice a day

Arms, Groups and Cohorts

  • Active Comparator: Besifloxocin
    • Use of topical besifloxocin to treat acute blepharitis
  • Active Comparator: Erythromycin
    • Topical Erythromycin ointment for treatment of acute blepharitis

Clinical Trial Outcome Measures

Primary Measures

  • Improvement in Signs and Symptoms of Blepharitis
    • Time Frame: Four weeks
    • Signs and symptoms of blepharitis were scored and determined before and after treatment with two different antibiotics

Secondary Measures

  • Evaluate Improvement of Bacterial Cultures With Two Different Topical Antibiotics
    • Time Frame: Three weeks
    • Compare improvement of microbial cultures (greater inhibition of bacterial growth) with the two antibiotics used to treat blepharitis

Participating in This Clinical Trial

Inclusion Criteria

Acute blepharitis, age 18-100, Signs and symptoms of blepharitis - Exclusion Criteria:

women of child bearing potential, eye surgery within three months of study, contact lens wear, use of topical or antibacterial agents in past two weeks, use of topical or oral steroids in past two weeks unless stable dosage -

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • John, George, M.D.
  • Collaborator
    • Bausch & Lomb Incorporated
  • Provider of Information About this Clinical Study
    • Principal Investigator: George John, M.D., Prinicipal Investigator – John, George, M.D.

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