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

Phase 4

Completed

• Conditions: Blepharitis
• Interventions: Drug: Besifloxocin; Drug: Erythromycin

• Registration Number: NCT01478256
• Lead Sponsor: John, George, M.D.

Brief Summary

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.

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.

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Study First Submitted: 2011-11-21
• Study First Submitted QC: 2011-11-22
• Study First Posted: 2011-11-23
• Results First Submitted: 2013-04-09
• Results First Submitted QC: 2013-09-17
• Status Verified: 2013-11
• Results First Posted: 2013-11-20
• Last Update Submitted: 2013-11-20
• Last Update Posted: 2013-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Besifloxocin	Besifloxocin	Use of topical besifloxocin to treat acute blepharitis
Erythromycin	Erythromycin	Topical Erythromycin ointment for treatment of acute blepharitis

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

George John, M.D.; 🇺🇸 Louisville, Kentucky, United States