Back to results

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

Primary Purpose

Blepharitis

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Erythromycin

Besifloxocin

About this trial

This is an interventional treatment trial for Blepharitis focused on measuring blepharitis, topical erythromycin, topical besifloxocin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

George John, M.D.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Besifloxocin

Erythromycin

Arm Description

Use of topical besifloxocin to treat acute blepharitis

Topical Erythromycin ointment for treatment of acute blepharitis

Outcomes

Primary Outcome Measures

Improvement in Signs and Symptoms of Blepharitis

Signs and symptoms of blepharitis were scored and determined before and after treatment with two different antibiotics

Secondary Outcome Measures

Evaluate Improvement of Bacterial Cultures With Two Different Topical Antibiotics

Compare improvement of microbial cultures (greater inhibition of bacterial growth) with the two antibiotics used to treat blepharitis

Full Information

NCT ID

NCT01478256

First Posted

November 21, 2011

Last Updated

November 20, 2013

Sponsor

John, George, M.D.

Collaborators

Bausch & Lomb Incorporated

1. Study Identification

Unique Protocol Identification Number

NCT01478256

Brief Title

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

Official Title

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

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Completed

Study Start Date

August 2011 (undefined)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

John, George, M.D.

Collaborators

Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Blepharitis

Keywords

blepharitis, topical erythromycin, topical besifloxocin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Besifloxocin

Arm Type

Active Comparator

Arm Description

Use of topical besifloxocin to treat acute blepharitis

Arm Title

Erythromycin

Arm Type

Active Comparator

Arm Description

Topical Erythromycin ointment for treatment of acute blepharitis

Intervention Type

Drug

Intervention Name(s)

Erythromycin

Intervention Description

Topical erythromycin ointment twice a day

Intervention Type

Drug

Intervention Name(s)

Besifloxocin

Other Intervention Name(s)

Besivance

Intervention Description

Topical Besifloxocin twice a day

Primary Outcome Measure Information:

Title

Improvement in Signs and Symptoms of Blepharitis

Description

Signs and symptoms of blepharitis were scored and determined before and after treatment with two different antibiotics

Time Frame

Four weeks

Secondary Outcome Measure Information:

Title

Evaluate Improvement of Bacterial Cultures With Two Different Topical Antibiotics

Description

Compare improvement of microbial cultures (greater inhibition of bacterial growth) with the two antibiotics used to treat blepharitis

Time Frame

Three weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 -

Facility Information:

Facility Name

George John, M.D.

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40205

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs