Bacterial Conjunctivitis
Conditions
Keywords
Ocular infections, bacterial
Brief summary
The objective of this study is to evaluate the safety and efficacy of Besivance (besifloxacin 0.6%) ophthalmic suspension compared to gatifloxacin 0.3% ophthalmic solution when administered three times daily (TID) for seven days to neonatal subjects who are 31 days or younger on the day of randomization (Visit 1).
Interventions
DRUGBesivance
Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days
DRUGGatifloxacin
Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Days to 31 Days
Healthy volunteers
No
Inclusion criteria
* Subjects who have a clinical diagnosis of acute bacterial conjunctivitis and exhibit conjunctival discharge and redness in at least one eye. A minimum score of 1 should be present for discharge and a minimum score of 1 for conjunctival hyperemia in the same eye.
Exclusion criteria
* Subjects with conjunctivitis signs and/or symptoms suggestive of fungal, protozoal, or viral etiology in either eye. * Subjects who require or are expected to require (other than study medication) use of any topical ocular medication in either eye, or systemic medications during the course of the study or prior to Day 1 specified in the protocol as ineligible. * Subjects with any abnormality of the ocular anatomy or ocular disease/disorder specified in the protocol as ineligible. * Subjects with systemic disease/disorder specified in the protocol as ineligible. * Subjects who have a known or suspected poor tolerance, sensitivity, or allergy to the study medications or any of their components. * Subjects who have a condition or are in a situation which in the investigator's opinion may impact their safety or would negatively affect the conduct or outcome of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Resolution | Visit 5 (Day 8+1) | Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Resolution | Visit 3 (Day 3) | Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia. |
| Microbial Eradication | Visit 5 (Day 8+1) | Eradication defined as the absence of all accepted ocular bacterial species (as measured on the ordinal scale) that were present at or above threshold at baseline |
| Microbial Outcome | Visit 3 (Day 3) and Visit 5 (Day 8+1) | Microbial outcome for the following groups of accepted ocular bacterial species that were present at or above threshold at baseline: * over all bacterial species * over all and individual gram-positive bacterial species * over all and individual gram-negative bacterial species |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Besivance Besifloxacin 0.6% ophthalmic suspension
Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days | 16 |
| Gatifloxacin Gatifloxacin 0.3% ophthalmic solution
Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days | 17 |
| Total | 33 |
Baseline characteristics
| Characteristic | Gatifloxacin | Total | Besivance |
|---|---|---|---|
| Age, Continuous | 14 days | 14 days | 17 days |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) White | 12 Participants | 24 Participants | 12 Participants |
| Sex: Female, Male Female | 7 Participants | 19 Participants | 12 Participants |
| Sex: Female, Male Male | 10 Participants | 14 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 5 / 17 |
| serious Total, serious adverse events | 0 / 16 | 0 / 17 |
Outcome results
Primary
Clinical Resolution
Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia.
Time frame: Visit 5 (Day 8+1)
Population: The analysis population only includes those for whom the outcome was measured within the specified time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Besivance | Clinical Resolution | 12 participants |
| Gatifloxacin | Clinical Resolution | 12 participants |
Secondary
Clinical Resolution
Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia.
Time frame: Visit 3 (Day 3)
Population: The analysis population only includes those for whom the outcome was measured within the specified time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Besivance | Clinical Resolution | 3 participants |
| Gatifloxacin | Clinical Resolution | 5 participants |
Secondary
Microbial Eradication
Eradication defined as the absence of all accepted ocular bacterial species (as measured on the ordinal scale) that were present at or above threshold at baseline
Time frame: Visit 5 (Day 8+1)
Population: The analysis population only includes those for whom the outcome was measured within the specified time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Besivance | Microbial Eradication | 12 participants |
| Gatifloxacin | Microbial Eradication | 8 participants |
Secondary
Microbial Outcome
Microbial outcome for the following groups of accepted ocular bacterial species that were present at or above threshold at baseline: * over all bacterial species * over all and individual gram-positive bacterial species * over all and individual gram-negative bacterial species
Time frame: Visit 3 (Day 3) and Visit 5 (Day 8+1)
Population: The analysis population only includes those for whom the outcome was measured within the specified time frame. A subject may have tested positive for multiple bacterial species (up to 5 species).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Besivance | Microbial Outcome | Visit 3 (Day 3) Gram-Positive | 16 events |
| Besivance | Microbial Outcome | Visit 3 (Day 3) Gram-Negative | 6 events |
| Besivance | Microbial Outcome | Visit 5 (Day 8) Gram-Positive | 17 events |
| Besivance | Microbial Outcome | Visit 5 (Day8) Gram-Negative | 6 events |
| Gatifloxacin | Microbial Outcome | Visit 5 (Day8) Gram-Negative | 4 events |
| Gatifloxacin | Microbial Outcome | Visit 3 (Day 3) Gram-Positive | 6 events |
| Gatifloxacin | Microbial Outcome | Visit 5 (Day 8) Gram-Positive | 12 events |
| Gatifloxacin | Microbial Outcome | Visit 3 (Day 3) Gram-Negative | 3 events |