Comparative Study in the Efficacy of Topical Besifloxocin With Erythromycin for the Management of Acute Blepharitis
Study Details
Study Description
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 |
---|---|---|
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Besifloxocin Use of topical besifloxocin to treat acute blepharitis |
Drug: Besifloxocin
Topical Besifloxocin twice a day
Other Names:
|
Active Comparator: Erythromycin Topical Erythromycin ointment for treatment of acute blepharitis |
Drug: Erythromycin
Topical erythromycin ointment twice a day
|
Outcome Measures
Primary Outcome Measures
- Improvement in Signs and Symptoms of Blepharitis [Four weeks]
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 [Three weeks]
Compare improvement of microbial cultures (greater inhibition of bacterial growth) with the two antibiotics used to treat blepharitis
Eligibility Criteria
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
-
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | George John, M.D. | Louisville | Kentucky | United States | 40205 |
Sponsors and Collaborators
- John, George, M.D.
- Bausch & Lomb Incorporated
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SAIRB-11-0007
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Besifloxocin | Erythromycin |
---|---|---|
Arm/Group Description | Use of topical besifloxocin twice a day to treat acute blepharitis | Topical Erythromycin ointment twice a day for treatment of acute blepharitis |
Period Title: Overall Study | ||
STARTED | 15 | 15 |
COMPLETED | 15 | 15 |
NOT COMPLETED | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Besifloxocin | Erythromycin | Total |
---|---|---|---|
Arm/Group Description | Use of topical besifloxocin twice a day to treat acute blepharitis | Topical Erythromycin ointment twice a day for treatment of acute blepharitis | Total of all reporting groups |
Overall Participants | 15 | 15 | 30 |
Age (Count of Participants) | |||
<=18 years |
0
0%
|
0
0%
|
0
0%
|
Between 18 and 65 years |
10
66.7%
|
10
66.7%
|
20
66.7%
|
>=65 years |
5
33.3%
|
5
33.3%
|
10
33.3%
|
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
48
(10)
|
50
(12)
|
49
(11)
|
Sex: Female, Male (Count of Participants) | |||
Female |
8
53.3%
|
7
46.7%
|
15
50%
|
Male |
7
46.7%
|
8
53.3%
|
15
50%
|
Region of Enrollment (participants) [Number] | |||
United States |
15
100%
|
15
100%
|
30
100%
|
Outcome Measures
Title | Improvement in Signs and Symptoms of Blepharitis |
---|---|
Description | Signs and symptoms of blepharitis were scored and determined before and after treatment with two different antibiotics |
Time Frame | Four weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Besifloxocin | Erythromycin |
---|---|---|
Arm/Group Description | Use of topical besifloxocin to treat acute blepharitis | Topical Erythromycin ointment for treatment of acute blepharitis |
Measure Participants | 15 | 15 |
Number [participants] |
15
100%
|
15
100%
|
Title | Evaluate Improvement of Bacterial Cultures With Two Different Topical Antibiotics |
---|---|
Description | Compare improvement of microbial cultures (greater inhibition of bacterial growth) with the two antibiotics used to treat blepharitis |
Time Frame | Three weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Besifloxocin | Erythromycin |
---|---|---|
Arm/Group Description | Use of topical besifloxocin twice a day to treat acute blepharitis | Topical Erythromycin ointment twice a day for treatment of acute blepharitis |
Measure Participants | 15 | 15 |
Number [participants] |
15
100%
|
15
100%
|
Adverse Events
Time Frame | ||||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Besifloxocin | Erythromycin | ||
Arm/Group Description | Use of topical besifloxocin to treat acute blepharitis | Topical Erythromycin ointment for treatment of acute blepharitis | ||
All Cause Mortality |
||||
Besifloxocin | Erythromycin | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
Besifloxocin | Erythromycin | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/15 (0%) | 0/15 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Besifloxocin | Erythromycin | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/15 (0%) | 0/15 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | George John |
---|---|
Organization | George John MD |
Phone | 5028949757 |
grjohn777@yahoo.com |
- SAIRB-11-0007