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The purpose of the study is to compare the effect of Polytrim Ophthalmic Solution and Moxifloxacin Ophthalmic Solution in treating your child's pink eye. Both these medications are approved by the Food and Drug Administration, for treatment of conjunctivitis. This study will investigate if both of the medications are equally good.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moxifloxacin Opthalmic solution | Active Comparator |
| |
| Polymyxin B-trimethoprim opthalmic solution | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| moxifloxacin | Drug | 1-2 drops three times a day for 8-10 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Normal Physical Examination of the Eye | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Negative Bacterial Culture | Conjunctival swab specimens were inoculated onto tryptic soy agar with 5% sheep blood and GC II agar supplemented with hemoglobin and isovialex with incubation at 35 degrees C in ambient air supplemented with 5% carbon dioxide for 48 hours. S pneumoniae, H influenzai and M Catarrhalis were identified. | 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francis Gigliotti, MD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14642 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Polytrim Group | Randomization to polytrim : 1-2 drops four times a day for 8-10 days. |
| FG001 | Moxifloxin Group | Randomization to topical moxifloxacin 1-2 drops 3x/day for 8-10 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Polytrim Ophthalmic Solution | randomization to topical polytrim |
| BG001 | Moxifloxacin Ophthalmic Solution | randomization to topical moxifloxacin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With Normal Physical Examination of the Eye | Posted | Number | participants | 10 days |
|
|
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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 | Moxifloxacin Treatment Group |
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No adverse events
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Franci Gigilotti | University of Rochester, Strong Mem orial Hospital | 585 275-0588 | francis_gigilotti@urmc.rochester.edu |
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| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| ID | Term |
|---|---|
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| C056487 | Polytrim eyedrops |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| polytrim | Drug | 1-2 drops four times a day for 8-10 days. |
|
| BG002 | Total | Total of all reporting groups |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Number of Participants With a Negative Bacterial Culture | Conjunctival swab specimens were inoculated onto tryptic soy agar with 5% sheep blood and GC II agar supplemented with hemoglobin and isovialex with incubation at 35 degrees C in ambient air supplemented with 5% carbon dioxide for 48 hours. S pneumoniae, H influenzai and M Catarrhalis were identified. | Only participants who were culture positive at baseline were tested at day 10. 20 participants were negative at baseline in the polytrim group and 11 participants were negative in the moxifloxin group. | Posted | Number | participants | 10 days |
|
|
|
| 0 |
| 62 |
| 0 |
| 62 |
| EG001 | Polytrim Treatment Group | 0 | 62 | 0 | 62 |
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| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |