Acute Bacterial Conjunctivitis
Conditions
Brief summary
Evaluation of the clinical and microbial efficacy of 0.6% ISV-403, compared to vehicle in the treatment of bacterial conjunctivitis.
Interventions
DRUGISV-403
Subjects with bacterial conjunctivitis were randomized to receive 0.6% ISV-403 eye drops three times a day (TID) for 5 days.
DRUGVehicle
Subjects with bacterial conjunctivitis were randomized to receive vehicle eye drops three times a day (TID) for 5 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
* Must have a diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in at least one eye. * Females of childbearing potential must utilized reliable contraceptive methods and have a negative pregnancy test.
Exclusion criteria
* Pregnant or nursing females. * Known hypersensitivity to fluoroquinolones or to any of the study ingredients. * Use of any antibiotic within 72 hours of treatment. * Any disease or condition that could interfere with the safety and efficacy evaluations of the study medications. * Participation in an ophthalmic drug or device research study within 30 days prior to entry into the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Resolution of Baseline Bacterial Conjunctivitis | Day 5 +/- 1 day | The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection |
| Microbial Eradication of Baseline Bacterial Infection | Day 5 +/- 1 day | Absence (grade 0 on the ordinal scale) of all ocular bacterial species that were present at or above the threshold value for that species from the Cagle list at baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Resolution of Baseline Bacterial Conjunctivitis | Day 8 or 9 | The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection |
| Microbial Eradication of Baseline Bacterial Infection | Day 8 or 9 | Absence (grade 0 on the ordinal scale) of all ocular bacterial species that were present at or above the threshold value for that species from the Cagle list at baseline. |
Participant flow
Recruitment details
First subject enrolled 6/5/2006, last patient exited on 11/7/2007. This study was conducted at multiple sites in the US.
Pre-assignment details
957 Subjects with bacterial conjunctivitis were randomized to receive besifloxacin ophthalmic suspension or its vehicle, 11 subjects were discontinued due to failure to meet enrollment criteria or used disallowed medications.
Participants by arm
| Arm | Count |
|---|---|
| ISV-403 Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days. | 475 |
| Vehicle Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days. | 482 |
| Total | 957 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 5 |
| Overall Study | Did not meet inclusion criteria | 4 | 8 |
| Overall Study | Lack of Efficacy | 3 | 14 |
| Overall Study | Lost to Follow-up | 10 | 9 |
| Overall Study | Withdrawal by Subject | 10 | 16 |
Baseline characteristics
| Characteristic | ISV-403 | Vehicle | Total |
|---|---|---|---|
| Age, Customized 20 to 59 years | 212 participants | 226 participants | 438 participants |
| Age, Customized 2 to 19 years | 196 participants | 196 participants | 392 participants |
| Age, Customized <2 years | 21 participants | 20 participants | 41 participants |
| Age, Customized >=60 years | 46 participants | 40 participants | 86 participants |
| Race/Ethnicity, Customized Asian | 10 Participants | 7 Participants | 17 Participants |
| Race/Ethnicity, Customized Black or African American | 44 Participants | 46 Participants | 90 Participants |
| Race/Ethnicity, Customized Caucasian | 312 Participants | 312 Participants | 624 Participants |
| Race/Ethnicity, Customized Other | 109 Participants | 117 Participants | 226 Participants |
| Region of Enrollment United States | 475 participants | 482 participants | 957 participants |
| Sex: Female, Male Female | 302 Participants | 300 Participants | 602 Participants |
| Sex: Female, Male Male | 173 Participants | 182 Participants | 355 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 741 | 0 / 760 |
| serious Total, serious adverse events | 1 / 442 | 1 / 432 |
Outcome results
Primary
Clinical Resolution of Baseline Bacterial Conjunctivitis
The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection
Time frame: Day 5 +/- 1 day
Population: Modified intent to treat population, culture confirmed, as randomized
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ISV-403 | Clinical Resolution of Baseline Bacterial Conjunctivitis | 90 Participants |
| Vehicle | Clinical Resolution of Baseline Bacterial Conjunctivitis | 63 Participants |
Primary
Microbial Eradication of Baseline Bacterial Infection
Absence (grade 0 on the ordinal scale) of all ocular bacterial species that were present at or above the threshold value for that species from the Cagle list at baseline.
Time frame: Day 5 +/- 1 day
Population: Modified Intent to treat population, culture confirmed, as randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ISV-403 | Microbial Eradication of Baseline Bacterial Infection | 182 Participants |
| Vehicle | Microbial Eradication of Baseline Bacterial Infection | 114 Participants |
Secondary
Clinical Resolution of Baseline Bacterial Conjunctivitis
The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection
Time frame: Day 8 or 9
Population: Modified intent to treat population, culture confirmed, as randomized
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ISV-403 | Clinical Resolution of Baseline Bacterial Conjunctivitis | 168 Participants |
| Vehicle | Clinical Resolution of Baseline Bacterial Conjunctivitis | 132 Participants |
Secondary
Microbial Eradication of Baseline Bacterial Infection
Absence (grade 0 on the ordinal scale) of all ocular bacterial species that were present at or above the threshold value for that species from the Cagle list at baseline.
Time frame: Day 8 or 9
Population: Modified intent to treat population, culture confirmed, as randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ISV-403 | Microbial Eradication of Baseline Bacterial Infection | 176 Participants |
| Vehicle | Microbial Eradication of Baseline Bacterial Infection | 137 Participants |