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

This study has been completed.
Sponsor:
Collaborator:
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
George John, M.D., John, George, M.D.
ClinicalTrials.gov Identifier:
NCT01478256
First received: November 21, 2011
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Blepharitis
Drug: Erythromycin
Drug: Besifloxocin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by John, George, M.D.:

Primary Outcome Measures:
  • Improvement in Signs and Symptoms of Blepharitis [ Time Frame: Four weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Three weeks ] [ Designated as safety issue: No ]
    Compare improvement of microbial cultures (greater inhibition of bacterial growth) with the two antibiotics used to treat blepharitis


Enrollment: 30
Study Start Date: August 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Besifloxocin
Use of topical besifloxocin to treat acute blepharitis
Drug: Besifloxocin
Topical Besifloxocin twice a day
Other Name: Besivance
Active Comparator: Erythromycin
Topical Erythromycin ointment for treatment of acute blepharitis
Drug: Erythromycin
Topical erythromycin ointment twice a day

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01478256

Locations
United States, Kentucky
George John, M.D.
Louisville, Kentucky, United States, 40205
Sponsors and Collaborators
John, George, M.D.
Bausch & Lomb Incorporated
  More Information

No publications provided

Responsible Party: George John, M.D., Prinicipal Investigator, John, George, M.D.
ClinicalTrials.gov Identifier: NCT01478256     History of Changes
Other Study ID Numbers: SAIRB-11-0007
Study First Received: November 21, 2011
Results First Received: April 9, 2013
Last Updated: November 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by John, George, M.D.:
blepharitis
topical erythromycin
topical besifloxocin

Additional relevant MeSH terms:
Blepharitis
Eyelid Diseases
Eye Diseases
Erythromycin stearate
Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on April 23, 2014