Bacterial Conjunctivitis
Conditions
Brief summary
This study is being conducted to evaluate the clinical and microbial efficacy of besifloxacin ophthalmic suspension compared with vehicle in the treatment of bacterial conjunctivitis. This study was conducted as a phase IIb study and continued with further enrollment as a phase III study.
Interventions
DRUGBesifloxacin
Besifloxacin 0.6% administered into the study eye two times a day for three days.
Vehicle administered to the study eye two times a day for three days.
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects who are at least one year of age. * Subjects who have a clinical diagnosis of acute bacterial conjunctivitis. * Subjects who are willing to discontinue contact lens wear for the duration of the study.
Exclusion criteria
* Subjects who have any uncontrolled systemic disease or debilitating disease. * Subjects with known sensitivity or contraindications to besifloxacin, fluoroquinolones or any ingredients in study drugs. * Subjects who are expected to require treatment with any disallowed medications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Resolution | Visit 2 | The absence of both conjunctival discharge and bulbar conjunctival injection. |
| Microbial Eradication | Visit 2 | The absence of ocular bacteria that were present at or above pathogenic threshold levels at baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Resolution | Visit 3 | The absence of both conjunctival discharge and bulbar conjunctival injection. |
| Microbial Eradication | Visit 3 | The absence of ocular bacteria that were present at or above pathogenic threshold levels at baseline. |
Countries
United States
Participant flow
Recruitment details
This was a two phase (IIB/III) integrated study. Phase IIb was conducted at 31 sites and Phase III at 28 sites in the United States. The first participant was enrolled in phase IIb on 10/30/2009, and last participant exited the study on 04/09/2010. Phase III enrolled its first participant on 04/05/2010 and last participant exited on 10/13/2010.
Pre-assignment details
A total of 474 participants were enrolled in the integrated study in the intent to treat(ITT) population. 276 participants had culture confirmed bacterial conjunctivitis and were assigned to the modified intent to treat(mITT) population. 464 participants were assigned to the safety population. 446 participants completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Besifloxacin 0.6% ophthalmic suspension | 231 |
| Vehicle Vehicle of besifloxacin ophthalmic suspension | 243 |
| Total | 474 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 2 |
| Overall Study | Lost to Follow-up | 0 | 4 |
| Overall Study | Missed visit | 1 | 0 |
| Overall Study | Physician Decision | 4 | 0 |
| Overall Study | Protocol Violation | 0 | 2 |
| Overall Study | Screening Failure | 2 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 5 |
Baseline characteristics
| Characteristic | Besifloxacin | Total | Vehicle |
|---|---|---|---|
| Age, Customized 12 - 17 years | 19 participants | 39 participants | 20 participants |
| Age, Customized 18 - 29 years | 32 participants | 72 participants | 40 participants |
| Age, Customized 2 - 11 years | 66 participants | 143 participants | 77 participants |
| Age, Customized <2 years | 14 participants | 27 participants | 13 participants |
| Age, Customized 30 - 39 years | 21 participants | 50 participants | 29 participants |
| Age, Customized 40 - 49 years | 23 participants | 37 participants | 14 participants |
| Age, Customized 50 - 59 years | 20 participants | 39 participants | 19 participants |
| Age, Customized >=60 years | 35 participants | 66 participants | 31 participants |
| Age, Customized Missing | 1 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 7 participants | 12 participants | 5 participants |
| Race/Ethnicity, Customized Asian | 7 participants | 14 participants | 7 participants |
| Race/Ethnicity, Customized Black or African American | 45 participants | 103 participants | 58 participants |
| Race/Ethnicity, Customized Missing | 1 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 participants | 2 participants | 2 participants |
| Race/Ethnicity, Customized Other | 4 participants | 9 participants | 5 participants |
| Race/Ethnicity, Customized White | 167 participants | 333 participants | 166 participants |
| Sex: Female, Male Female | 142 Participants | 275 Participants | 133 Participants |
| Sex: Female, Male Male | 89 Participants | 199 Participants | 110 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 228 | 0 / 236 |
| serious Total, serious adverse events | 0 / 228 | 0 / 236 |
Outcome results
Primary
Clinical Resolution
The absence of both conjunctival discharge and bulbar conjunctival injection.
Time frame: Visit 2
Population: Clinical Resolution at Visit 2, (LOCF), mITT Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Besifloxacin | Clinical Resolution | 89 eyes |
| Vehicle | Clinical Resolution | 62 eyes |
Primary
Microbial Eradication
The absence of ocular bacteria that were present at or above pathogenic threshold levels at baseline.
Time frame: Visit 2
Population: Microbial Eradication at Visit 2, (LOCF), mITT Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Besifloxacin | Microbial Eradication | 115 eyes |
| Vehicle | Microbial Eradication | 77 eyes |
Secondary
Clinical Resolution
The absence of both conjunctival discharge and bulbar conjunctival injection.
Time frame: Visit 3
Population: Clinical Resolution at Visit 3, (LOCF) mITT Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Besifloxacin | Clinical Resolution | 103 eyes |
| Vehicle | Clinical Resolution | 94 eyes |
Secondary
Microbial Eradication
The absence of ocular bacteria that were present at or above pathogenic threshold levels at baseline.
Time frame: Visit 3
Population: Microbial Eradication at Visit 3, (LOCF), mITT Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Besifloxacin | Microbial Eradication | 115 eyes |
| Vehicle | Microbial Eradication | 91 eyes |