Blepharitis
Conditions
Keywords
blepharitis, topical erythromycin, topical besifloxocin
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.
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.
Interventions
DRUGErythromycin
Topical erythromycin ointment twice a day
DRUGBesifloxocin
Topical Besifloxocin twice a day
Sponsors
Bausch & Lomb Incorporated
John, George, M.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Besifloxocin Use of topical besifloxocin twice a day to treat acute blepharitis | 15 |
| Erythromycin Topical Erythromycin ointment twice a day for treatment of acute blepharitis | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Erythromycin | Besifloxocin | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 5 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 20 Participants |
| Age, Continuous | 50 years STANDARD_DEVIATION 12 | 48 years STANDARD_DEVIATION 10 | 49 years STANDARD_DEVIATION 11 |
| Region of Enrollment United States | 15 participants | 15 participants | 30 participants |
| Sex: Female, Male Female | 7 Participants | 8 Participants | 15 Participants |
| Sex: Female, Male Male | 8 Participants | 7 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
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
Time frame: Four weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Besifloxocin | Improvement in Signs and Symptoms of Blepharitis | 15 participants |
| Erythromycin | Improvement in Signs and Symptoms of Blepharitis | 15 participants |
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
Time frame: Three weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Besifloxocin | Evaluate Improvement of Bacterial Cultures With Two Different Topical Antibiotics | 15 participants |
| Erythromycin | Evaluate Improvement of Bacterial Cultures With Two Different Topical Antibiotics | 15 participants |