Comparative Study in the Efficacy of Topical Besifloxocin With Erythromycin for the Management of Acute Blepharitis
Information source: John, George, M.D.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Blepharitis
Intervention: Erythromycin (Drug); Besifloxocin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: John, George, M.D.
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Improvement in Signs and Symptoms of Blepharitis
Secondary outcome: Evaluate Improvement of Bacterial Cultures With Two Different Topical Antibiotics
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
-
Locations and Contacts
George John, M.D., Louisville, Kentucky 40205, United States
Additional Information
Starting date: August 2011
Last updated: November 20, 2013
|