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

Blepharitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01478256
• Other study ID #: SAIRB-11-0007
• Status: Completed
• Phase: Phase 4
• First received: November 21, 2011
• Last updated: November 20, 2013
• Start date: August 2011
• Est. completion date: October 2011

Study information

• Verified date: November 2013
• Source: John, George, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blepharitis

Intervention

Drug:
• Erythromycin
Topical erythromycin ointment twice a day
• Besifloxocin
Topical Besifloxocin twice a day

Locations

Country	Name	City	State
United States	George John, M.D.	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
John, George, M.D.	Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in Signs and Symptoms of Blepharitis	Signs and symptoms of blepharitis were scored and determined before and after treatment with two different antibiotics	Four weeks	No
Secondary	Evaluate Improvement of Bacterial Cultures With Two Different Topical Antibiotics	Compare improvement of microbial cultures (greater inhibition of bacterial growth) with the two antibiotics used to treat blepharitis	Three weeks	No