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Trial record 12 of 182 for:    ERYTHROMYCIN

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01478256
Recruitment Status : Completed
First Posted : November 23, 2011
Results First Posted : November 20, 2013
Last Update Posted : December 19, 2013
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
George John, M.D., 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.

Condition or disease Intervention/treatment Phase
Blepharitis Drug: Erythromycin Drug: Besifloxocin 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.

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Study Type : Interventional  (Clinical Trial)
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 : August 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01478256

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

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Responsible Party: George John, M.D., Prinicipal Investigator, John, George, M.D. Identifier: NCT01478256     History of Changes
Other Study ID Numbers: SAIRB-11-0007
First Posted: November 23, 2011    Key Record Dates
Results First Posted: November 20, 2013
Last Update Posted: December 19, 2013
Last Verified: November 2013
Keywords provided by George John, M.D., John, George, M.D.:
topical erythromycin
topical besifloxocin
Additional relevant MeSH terms:
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Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin stearate
Eyelid Diseases
Eye Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action