Bacterial Conjunctivitis
Conditions
Brief summary
To evaluate the clinical and microbial efficacy of besifloxacin ophthalmic suspension, 0.6% (Besifloxacin) administered BID for 3 days compared to vehicle in the treatment of bacterial conjunctivitis.
Interventions
DRUGBesifloxacin
one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days.
DRUGVehicle
one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 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
* Have a clinical diagnosis of acute bacterial conjunctivitis and exhibit mucopurulent/purulent conjunctival discharge (crusty or sticky eyelids) and redness in at least 1 eye. A minimum score of 1 should be present for both discharge and for bulbar conjunctival injection. * Have monocular pin-holed Snellen visual acuity (VA) equal to or better than 20/200 in both eyes. Age appropriate VA testing will be performed. Every effort should be made to obtain a VA measurement in children. If VA is unobtainable in children, it is at the Investigator's discretion to include the subject in the study. * Be willing to discontinue contact lens wear for the duration of the study.
Exclusion criteria
* Have a severe/serious ocular condition or history/presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result(s) of the study. * Have a known hypersensitivity or contraindications to besifloxacin, fluoroquinolones, or any of the ingredients in the study drugs. * Be expected to require treatment with systemic or ocular (either eye) nonsteroidal anti-inflammatory drugs (NSAIDs), antihistamines, or corticosteroids during the study or have used any of these medications within 2 days prior to study start. * Be expected to require concurrent ocular therapy in either eye with any ophthalmic solutions (unless specified below), including tear substitutes, during the study or have used any ophthalmic solutions within 2 hours prior to study start. Be expected to require concurrent ocular therapy (either eye) with mast cell stabilizers or decongestants during the study or have used any of the above within 2 days prior to study start. * Be expected to require concurrent systemic or ocular therapy with immunosuppressants (eg, Restasis) during the study or have used systemic or ocular immunosuppressants within 30 days prior to study start. * Be expected to require treatment with systemic or ocular (either eye) antibacterials (other than study drug) during the study or have used any systemic or ocular antibacterial within 3 days prior to study start. * Be likely to require antimicrobial therapy for conditions such as respiratory tract infection, urinary tract infection, skin/soft tissue infection, or otitis media during the study. * Have had ocular surgery (including laser surgery) in either eye within 6 weeks prior to entry into this study. * Have suspected viral or allergic conjunctivitis or any other disease conditions that could interfere with the efficacy and safety evaluations of the study medication. * Have suspected iritis * Have a history of recurrent corneal erosion syndrome, either idiopathic or secondary to previous corneal trauma or dry eye syndrome. * Have any active ulcerative keratitis, specifically any epithelial loss greater than punctate keratitis. * Be immune compromised.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Resolution | Visit 2 (Day 4 or 5) | Absence of both conjunctival discharge and bulbar conjunctival injection, after 3 days of treatment with besifloxacin ophthalmic suspension 0.6% |
| Microbial Eradication | Visit 2 (Day 4 or 5) | Absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after 3 days of treatment with besifloxacin ophthalmic suspension 0.6% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Resolution | Visit 3 (Day 6, 7, or 8) | Absence of both conjunctival discharge and bulbar conjunctival injection, after 3 days of treatment with besifloxacin ophthalmic suspension 0.6% |
| Microbial Eradication | Visit 3 (Day 6, 7, or 8) | Absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after 3 days of treatment with besifloxacin ophthalmic suspension 0.6% |
Other
| Measure | Time frame | Description |
|---|---|---|
| Ocular Conjunctival Discharge | At each follow-up visit (Visit 1, Visit 2 and Visit 3) | Ocular conjunctival discharge measures on a scale of 0-3 where 0 = Absent, 1 = Mild, 2 = Moderate and 3 = Severe |
| Bulbar Conjunctival Injection | At each follow-up visit (Visit 1, Visit 2 and Visit 3) | Bulbar conjunctival injection measured on a scale of 0-3 where 0 = Normal, 1 = Mild, 2 = Moderate and 3 = Severe |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Besifloxacin besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis
Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days. | 64 |
| Vehicle vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis
Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days. | 72 |
| Total | 136 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Physician Decision | 2 | 6 |
| Overall Study | Subjects missing data, completed | 41 | 36 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Vehicle | Total | Besifloxacin |
|---|---|---|---|
| Age, Continuous | 50.6 years STANDARD_DEVIATION 21.36 | 47.8 years STANDARD_DEVIATION 22.03 | 44.6 years STANDARD_DEVIATION 22.52 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 11 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 11 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) White | 56 Participants | 107 Participants | 51 Participants |
| Sex: Female, Male Female | 44 Participants | 88 Participants | 44 Participants |
| Sex: Female, Male Male | 28 Participants | 48 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 64 | 3 / 72 |
| serious Total, serious adverse events | 0 / 64 | 0 / 72 |
Outcome results
Primary
Clinical Resolution
Absence of both conjunctival discharge and bulbar conjunctival injection, after 3 days of treatment with besifloxacin ophthalmic suspension 0.6%
Time frame: Visit 2 (Day 4 or 5)
Population: Analysis population is only Subjects with non-missing data, Clinical Resolution (LOCF \[Last Observation Carried Forward\])
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Besifloxacin | Clinical Resolution | YES | 4 participants |
| Besifloxacin | Clinical Resolution | NO | 14 participants |
| Vehicle | Clinical Resolution | YES | 5 participants |
| Vehicle | Clinical Resolution | NO | 23 participants |
Primary
Microbial Eradication
Absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after 3 days of treatment with besifloxacin ophthalmic suspension 0.6%
Time frame: Visit 2 (Day 4 or 5)
Population: Analysis population is only Subjects with non-missing data, Microbial Eradication (LOCF \[Last Observation Carried Forward\])
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Besifloxacin | Microbial Eradication | YES | 17 participants |
| Besifloxacin | Microbial Eradication | NO | 1 participants |
| Vehicle | Microbial Eradication | YES | 13 participants |
| Vehicle | Microbial Eradication | NO | 15 participants |
Secondary
Clinical Resolution
Absence of both conjunctival discharge and bulbar conjunctival injection, after 3 days of treatment with besifloxacin ophthalmic suspension 0.6%
Time frame: Visit 3 (Day 6, 7, or 8)
Population: Analysis population is only Subjects with non-missing data, Clinical Resolution (LOCF \[Last Observation Carried Forward\])
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Besifloxacin | Clinical Resolution | YES | 6 participants |
| Besifloxacin | Clinical Resolution | NO | 12 participants |
| Vehicle | Clinical Resolution | YES | 13 participants |
| Vehicle | Clinical Resolution | NO | 15 participants |
Secondary
Microbial Eradication
Absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after 3 days of treatment with besifloxacin ophthalmic suspension 0.6%
Time frame: Visit 3 (Day 6, 7, or 8)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Besifloxacin | Microbial Eradication | YES | 14 participants |
| Besifloxacin | Microbial Eradication | NO | 4 participants |
| Vehicle | Microbial Eradication | YES | 16 participants |
| Vehicle | Microbial Eradication | NO | 12 participants |
Other Pre-specified
Bulbar Conjunctival Injection
Bulbar conjunctival injection measured on a scale of 0-3 where 0 = Normal, 1 = Mild, 2 = Moderate and 3 = Severe
Time frame: At each follow-up visit (Visit 1, Visit 2 and Visit 3)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Besifloxacin | Bulbar Conjunctival Injection | Visit 1: Normal | 0 participants |
| Besifloxacin | Bulbar Conjunctival Injection | Visit 1: Mild | 3 participants |
| Besifloxacin | Bulbar Conjunctival Injection | Visit 1: Moderate | 14 participants |
| Besifloxacin | Bulbar Conjunctival Injection | Visit 1: Severe | 1 participants |
| Besifloxacin | Bulbar Conjunctival Injection | Visit 2: Normal | 4 participants |
| Besifloxacin | Bulbar Conjunctival Injection | Visit 2: Mild | 13 participants |
| Besifloxacin | Bulbar Conjunctival Injection | Visit 2: Moderate | 1 participants |
| Besifloxacin | Bulbar Conjunctival Injection | Visit 2: Severe | 0 participants |
| Besifloxacin | Bulbar Conjunctival Injection | Visit 3: Normal | 7 participants |
| Besifloxacin | Bulbar Conjunctival Injection | Visit 3: Mild | 11 participants |
| Besifloxacin | Bulbar Conjunctival Injection | Visit 3: Moderate | 0 participants |
| Besifloxacin | Bulbar Conjunctival Injection | Visit 3: Severe | 0 participants |
| Vehicle | Bulbar Conjunctival Injection | Visit 3: Moderate | 5 participants |
| Vehicle | Bulbar Conjunctival Injection | Visit 1: Normal | 0 participants |
| Vehicle | Bulbar Conjunctival Injection | Visit 2: Moderate | 8 participants |
| Vehicle | Bulbar Conjunctival Injection | Visit 1: Mild | 6 participants |
| Vehicle | Bulbar Conjunctival Injection | Visit 3: Mild | 6 participants |
| Vehicle | Bulbar Conjunctival Injection | Visit 1: Moderate | 18 participants |
| Vehicle | Bulbar Conjunctival Injection | Visit 2: Severe | 0 participants |
| Vehicle | Bulbar Conjunctival Injection | Visit 1: Severe | 4 participants |
| Vehicle | Bulbar Conjunctival Injection | Visit 3: Severe | 1 participants |
| Vehicle | Bulbar Conjunctival Injection | Visit 2: Normal | 7 participants |
| Vehicle | Bulbar Conjunctival Injection | Visit 3: Normal | 12 participants |
| Vehicle | Bulbar Conjunctival Injection | Visit 2: Mild | 12 participants |
Other Pre-specified
Ocular Conjunctival Discharge
Ocular conjunctival discharge measures on a scale of 0-3 where 0 = Absent, 1 = Mild, 2 = Moderate and 3 = Severe
Time frame: At each follow-up visit (Visit 1, Visit 2 and Visit 3)
Population: Analysis population is only Subjects with non-missing data, Ocular Discharge Evaluated on the Baseline-Designated Study Eye
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Besifloxacin | Ocular Conjunctival Discharge | Visit 1: Absent | 0 participants |
| Besifloxacin | Ocular Conjunctival Discharge | Visit 1: Mild | 6 participants |
| Besifloxacin | Ocular Conjunctival Discharge | Visit 1: Moderate | 10 participants |
| Besifloxacin | Ocular Conjunctival Discharge | Visit 1: Severe | 2 participants |
| Besifloxacin | Ocular Conjunctival Discharge | Visit 2: Absent | 9 participants |
| Besifloxacin | Ocular Conjunctival Discharge | Visit 2: Mild | 8 participants |
| Besifloxacin | Ocular Conjunctival Discharge | Visit 2: Moderate | 1 participants |
| Besifloxacin | Ocular Conjunctival Discharge | Visit 2: Severe | 0 participants |
| Besifloxacin | Ocular Conjunctival Discharge | Visit 3: Absent | 14 participants |
| Besifloxacin | Ocular Conjunctival Discharge | Visit 3: Mild | 4 participants |
| Besifloxacin | Ocular Conjunctival Discharge | Visit 3: Moderate | 0 participants |
| Besifloxacin | Ocular Conjunctival Discharge | Visit 3: Severe | 0 participants |
| Vehicle | Ocular Conjunctival Discharge | Visit 3: Moderate | 3 participants |
| Vehicle | Ocular Conjunctival Discharge | Visit 1: Absent | 0 participants |
| Vehicle | Ocular Conjunctival Discharge | Visit 2: Moderate | 2 participants |
| Vehicle | Ocular Conjunctival Discharge | Visit 1: Mild | 9 participants |
| Vehicle | Ocular Conjunctival Discharge | Visit 3: Mild | 5 participants |
| Vehicle | Ocular Conjunctival Discharge | Visit 1: Moderate | 16 participants |
| Vehicle | Ocular Conjunctival Discharge | Visit 2: Severe | 0 participants |
| Vehicle | Ocular Conjunctival Discharge | Visit 1: Severe | 3 participants |
| Vehicle | Ocular Conjunctival Discharge | Visit 3: Severe | 0 participants |
| Vehicle | Ocular Conjunctival Discharge | Visit 2: Absent | 10 participants |
| Vehicle | Ocular Conjunctival Discharge | Visit 3: Absent | 16 participants |
| Vehicle | Ocular Conjunctival Discharge | Visit 2: Mild | 15 participants |