Acute Bacterial Conjunctivitis
Conditions
Brief summary
This is a study to investigate a novel drug candidate for the treatment of bacterial conjunctivitis.
Interventions
DRUGBesifloxacin
Besifloxacin hydrochloride ophthalmic suspension, 0.6% as base, administered TID for 5 days
DRUGMoxifloxacin solution
Moxifloxacin hydrochloride ophthalmic solution 0.5% administered TID for 5 days.
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in at least one eye.
Exclusion criteria
* Pregnant or nursing females. * Use of any antibiotic within 72 hours of enrollment. * Any disease conditions that could interfere with the safety and efficacy evaluations of the study drug. * Participation in an ophthalmic drug or device research study within 30 days prior to entry into this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Resolution | Day 5(+/- 1 day) | Resolution of conjunctival discharge and bulbar conjunctival injection. (mITT, culture confirmed, as treated) |
| Microbial Eradication | Day 5 (+/- 1 day) | eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Resolution | Day 8 or Day 9 | Clinical resolution of conjunctival discharge and bulbar conjunctival injection, modified intent to treat (mITT), culture confirmed, as treated |
| Microbial Eradication | Day 8 or Day 9 | Microbial eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated |
Participant flow
Recruitment details
This study was conducted at 84 sites in the US and Asia. First subject was enrolled 6/6/06, and last subject visit was 7/13/07.
Pre-assignment details
1161 participants were randomized of which 533 had culture confirmed bacterial conjunctivitis.
Participants by arm
| Arm | Count |
|---|---|
| Moxifloxacin Solution Moxifloxacin hydrochloride ophthalmic solution 0.5% | 579 |
| Besifloxacin Suspension Besifloxacin ophthalmic suspension 0.6% | 582 |
| Total | 1,161 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse event probably related to study | 1 | 0 |
| Overall Study | Adverse event - unrelated to study drug | 0 | 1 |
| Overall Study | Dissallowed Meds - possibly releated | 1 | 1 |
| Overall Study | Dissallowed Meds - unlikley related | 1 | 1 |
| Overall Study | Dissallowed Meds - unrelated to study | 1 | 3 |
| Overall Study | Lack of Efficacy | 1 | 1 |
| Overall Study | Lost to Follow-up | 8 | 10 |
| Overall Study | Other | 7 | 4 |
| Overall Study | Withdrawal by Subject | 4 | 1 |
| Overall Study | Worsening of BC - Unlikely related | 1 | 2 |
| Overall Study | Worsening of BC - Unrelated to study | 0 | 3 |
Baseline characteristics
| Characteristic | Moxifloxacin Solution | Total | Besifloxacin Suspension |
|---|---|---|---|
| Age, Customized 10 to 19 years | 81 participants | 156 participants | 75 participants |
| Age, Customized 20 to 29 years | 73 participants | 166 participants | 93 participants |
| Age, Customized 2 to 9 years | 90 participants | 181 participants | 91 participants |
| Age, Customized <2 years | 15 participants | 37 participants | 22 participants |
| Age, Customized 30 to 39 years | 76 participants | 147 participants | 71 participants |
| Age, Customized 40 to 49 years | 59 participants | 127 participants | 68 participants |
| Age, Customized 50 to 59 years | 65 participants | 128 participants | 63 participants |
| Age, Customized >/= 60 years | 120 participants | 219 participants | 99 participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 6 participants | 9 participants | 3 participants |
| Race/Ethnicity, Customized Asian | 89 participants | 176 participants | 87 participants |
| Race/Ethnicity, Customized Black or African American | 63 participants | 136 participants | 73 participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 2 participants | 7 participants | 5 participants |
| Race/Ethnicity, Customized Other | 28 participants | 57 participants | 29 participants |
| Race/Ethnicity, Customized White | 391 participants | 776 participants | 385 participants |
| Sex: Female, Male Female | 323 Participants | 655 Participants | 332 Participants |
| Sex: Female, Male Male | 256 Participants | 506 Participants | 250 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 855 | 0 / 865 |
| serious Total, serious adverse events | 1 / 579 | 1 / 582 |
Outcome results
Primary
Clinical Resolution
Resolution of conjunctival discharge and bulbar conjunctival injection. (mITT, culture confirmed, as treated)
Time frame: Day 5(+/- 1 day)
Population: modified intent to treat (mITT), culture confirmed, as treated
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Moxifloxacin Solution | Clinical Resolution | 167 Participants |
| Besifloxacin Suspension | Clinical Resolution | 147 Participants |
Primary
Microbial Eradication
eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated
Time frame: Day 5 (+/- 1 day)
Population: modified intent to treat (mITT), culture confirmed, as treated
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Moxifloxacin Solution | Microbial Eradication | 256 Participants |
| Besifloxacin Suspension | Microbial Eradication | 235 Participants |
Secondary
Clinical Resolution
Clinical resolution of conjunctival discharge and bulbar conjunctival injection, modified intent to treat (mITT), culture confirmed, as treated
Time frame: Day 8 or Day 9
Population: modified intent to treat (mITT), culture confirmed, as treated
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Moxifloxacin Solution | Clinical Resolution | 236 Participants |
| Besifloxacin Suspension | Clinical Resolution | 213 Participants |
Secondary
Microbial Eradication
Microbial eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated
Time frame: Day 8 or Day 9
Population: modified intent to treat (mITT), culture confirmed, as treated
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Moxifloxacin Solution | Microbial Eradication | 238 Participants |
| Besifloxacin Suspension | Microbial Eradication | 220 Participants |