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

Sponsor
John, George, M.D. (Industry)
Overall Status
Completed
CT.gov ID
NCT01478256
Collaborator
Bausch & Lomb Incorporated (Industry)
30
1
2
2
15

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Aug 1, 2011
Actual Primary Completion Date :
Oct 1, 2011
Actual Study Completion Date :
Oct 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Besifloxocin

Use of topical besifloxocin to treat acute blepharitis

Drug: Besifloxocin
Topical Besifloxocin twice a day
Other Names:
  • Besivance
  • Active Comparator: Erythromycin

    Topical Erythromycin ointment for treatment of acute blepharitis

    Drug: Erythromycin
    Topical erythromycin ointment twice a day

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 George John, M.D. Louisville Kentucky United States 40205

    Sponsors and Collaborators

    • John, George, M.D.
    • Bausch & Lomb Incorporated

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    George John, M.D., Prinicipal Investigator, John, George, M.D.
    ClinicalTrials.gov Identifier:
    NCT01478256
    Other Study ID Numbers:
    • SAIRB-11-0007
    First Posted:
    Nov 23, 2011
    Last Update Posted:
    Dec 19, 2013
    Last Verified:
    Nov 1, 2013
    Keywords provided by George John, M.D., Prinicipal Investigator, John, George, M.D.
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Besifloxocin Erythromycin
    Arm/Group Description Use of topical besifloxocin twice a day to treat acute blepharitis Topical Erythromycin ointment twice a day for treatment of acute blepharitis
    Period Title: Overall Study
    STARTED 15 15
    COMPLETED 15 15
    NOT COMPLETED 0 0

    Baseline Characteristics

    Arm/Group Title Besifloxocin Erythromycin Total
    Arm/Group Description Use of topical besifloxocin twice a day to treat acute blepharitis Topical Erythromycin ointment twice a day for treatment of acute blepharitis Total of all reporting groups
    Overall Participants 15 15 30
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    10
    66.7%
    10
    66.7%
    20
    66.7%
    >=65 years
    5
    33.3%
    5
    33.3%
    10
    33.3%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    48
    (10)
    50
    (12)
    49
    (11)
    Sex: Female, Male (Count of Participants)
    Female
    8
    53.3%
    7
    46.7%
    15
    50%
    Male
    7
    46.7%
    8
    53.3%
    15
    50%
    Region of Enrollment (participants) [Number]
    United States
    15
    100%
    15
    100%
    30
    100%

    Outcome Measures

    1. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Besifloxocin Erythromycin
    Arm/Group Description Use of topical besifloxocin to treat acute blepharitis Topical Erythromycin ointment for treatment of acute blepharitis
    Measure Participants 15 15
    Number [participants]
    15
    100%
    15
    100%
    2. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Besifloxocin Erythromycin
    Arm/Group Description Use of topical besifloxocin twice a day to treat acute blepharitis Topical Erythromycin ointment twice a day for treatment of acute blepharitis
    Measure Participants 15 15
    Number [participants]
    15
    100%
    15
    100%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Besifloxocin Erythromycin
    Arm/Group Description Use of topical besifloxocin to treat acute blepharitis Topical Erythromycin ointment for treatment of acute blepharitis
    All Cause Mortality
    Besifloxocin Erythromycin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Besifloxocin Erythromycin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/15 (0%) 0/15 (0%)
    Other (Not Including Serious) Adverse Events
    Besifloxocin Erythromycin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/15 (0%) 0/15 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title George John
    Organization George John MD
    Phone 5028949757
    Email grjohn777@yahoo.com
    Responsible Party:
    George John, M.D., Prinicipal Investigator, John, George, M.D.
    ClinicalTrials.gov Identifier:
    NCT01478256
    Other Study ID Numbers:
    • SAIRB-11-0007
    First Posted:
    Nov 23, 2011
    Last Update Posted:
    Dec 19, 2013
    Last Verified:
    Nov 1, 2013