Conjunctivitis
Conditions
Brief summary
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.
Interventions
DRUGmoxifloxacin
1-2 drops three times a day for 8-10 days.
DRUGpolytrim
1-2 drops four times a day for 8-10 days.
Sponsors
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* 1 - 18 years of age with presumed bacterial conjunctivitis.
Exclusion criteria
* Previous antibiotics or to receive systemic antibiotic.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Normal Physical Examination of the Eye | 10 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Negative Bacterial Culture | 10 days | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Polytrim Ophthalmic Solution randomization to topical polytrim | 62 |
| Moxifloxacin Ophthalmic Solution randomization to topical moxifloxacin | 62 |
| Total | 124 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 9 | 21 |
| Overall Study | they met an exclusion criteria | 2 | 2 |
Baseline characteristics
| Characteristic | Polytrim Ophthalmic Solution | Moxifloxacin Ophthalmic Solution | Total |
|---|---|---|---|
| Age, Continuous | 73.4 months STANDARD_DEVIATION 50 | 70.3 months STANDARD_DEVIATION 48 | 71.3 months STANDARD_DEVIATION 49 |
| Region of Enrollment United States | 62 participants | 62 participants | 124 participants |
| Sex: Female, Male Female | 39 Participants | 28 Participants | 67 Participants |
| Sex: Female, Male Male | 23 Participants | 34 Participants | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 62 | 0 / 62 |
| serious Total, serious adverse events | 0 / 62 | 0 / 62 |
Outcome results
Primary
Number of Participants With Normal Physical Examination of the Eye
Time frame: 10 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Polytrim Arm | Number of Participants With Normal Physical Examination of the Eye | 49 participants |
| Moxifloxacin | Number of Participants With Normal Physical Examination of the Eye | 37 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.
Time frame: 10 days
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Polytrim Arm | Number of Participants With a Negative Bacterial Culture | 22 participants |
| Moxifloxacin | Number of Participants With a Negative Bacterial Culture | 19 participants |