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| Name | Class |
|---|---|
| Bausch & Lomb Incorporated | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Besifloxocin | Active Comparator | Use of topical besifloxocin to treat acute blepharitis |
|
| Erythromycin | Active Comparator | Topical Erythromycin ointment for treatment of acute blepharitis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erythromycin | Drug | Topical erythromycin ointment twice a day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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
-
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| George John, M.D. | Louisville | Kentucky | 40205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Besifloxocin | Use of topical besifloxocin twice a day to treat acute blepharitis |
| FG001 | Erythromycin | Topical Erythromycin ointment twice a day for treatment of acute blepharitis |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Besifloxocin | Use of topical besifloxocin twice a day to treat acute blepharitis |
| BG001 | Erythromycin | Topical Erythromycin ointment twice a day for treatment of acute blepharitis |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Number | participants | Four weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Besifloxocin | Use of topical besifloxocin to treat acute blepharitis |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| George John | George John MD | 5028949757 | grjohn777@yahoo.com |
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| ID | Term |
|---|---|
| D001762 | Blepharitis |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D004917 | Erythromycin |
| C522124 | besifloxacin |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Besifloxocin |
| Drug |
Topical Besifloxocin twice a day |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| 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 | Posted | Number | participants | Three weeks |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Erythromycin | Topical Erythromycin ointment for treatment of acute blepharitis | 0 | 15 | 0 | 15 |
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