Comparative Study in the Efficacy of Topical Besifloxocin With Erythromycin for the Management of Acute Blepharitis
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.
|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|
- 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
- Evaluate improvement of bacterial cultures with two different topical antibiotics [ Time Frame: Three weeks ] [ Designated as safety issue: No ]Compare improvement of microbial cultures with the two antibiotics used to treat blepharitis
|Study Start Date:||August 2011|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Active Comparator: Besifloxocin
Use of topical besifloxocin to treat acute blepharitis
Topical Besifloxocin twice a day
Other Name: Besivance
Active Comparator: Erythromycin
Topical Erythromycin ointment for treatment of acute blepharitis
Topical erythromycin ointment twice a day
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.