Bacterial Conjunctivitis
Conditions
Brief summary
To evaluate the clinical and microbial efficacy of ISV-403 administered three times a day (TID) for 5 days compared to vehicle three times a day for 5 days in the treatment of bacterial conjunctivitis
Interventions
DRUGISV-403
0.6% TID, 5 days
DRUGVehicle
Vehicle of ISV-403 TID, 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 be at least one year of age. * Must have signature of subject or legally authorized representative (if subject is under 18 years of age) on the informed Consent Form. * Must have signature of subject on the Assent Form if subject is 6 to 17 years of age. * Must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge (crusty or sticky eyelids) and redness in at least one eye. A minimum score of 1 should be present for discharge and a minimum score of 1 for either bulbar or palpebral conjunctival injection. * Must have pinholed visual acuity equal to or better than 20/200 in both eyes. Age appropriate visual acuity testing was to be performed. Every effort was made to obtain a visual acuity measurement in children. If visual acuity was unobtainable in children, it was at the investigator's discretion to meet inclusion criteria. * Must be willing to discontinue contact lens wear for the duration of the study. * Must be willing to avoid disallowed medications during the study period. * Must understand the scope of the study including completion of diary, be willing to follow instructions, and be able to make all required study visits. * If a subject was a female of childbearing potential, she must utilize reliable contraceptive methods and have a negative pregnancy test.
Exclusion criteria
* Any uncontrolled systemic disease or debilitating disease. * Use of topical ophthalmic solutions including tear substitutes within two hours before and during the study. * Use of any ophthalmic topical anti-inflammatory agents within 48 hours before and during the study. * Subjects likely to require antimicrobial therapy with any active respiratory tract infection, urinary tract infection, skin/soft tissue infection, or otitis media. * Pregnant or nursing females. * Known hypersensitivity to SS734 or to any of the ingredients in the study medications. * Known hypersensitivity to fluoroquinolones or to any of the ingredients in the study medications. * Ocular surgery (including laser surgery) in either eye within the past six weeks. * Subjects with suspected viral or allergic conjunctivitis (i.e., severe itching or acute follicular conjunctivitis), or any other disease conditions that could interfere with the efficacy and safety evaluations of the study medication. * Subjects with suspected iritis (i.e., smaller pupil, pain, and photophobia in infected eye). * History of recurrent corneal erosion syndrome, either idiopathic or secondary to previous corneal trauma or dry eye syndrome. * Use of any antibiotic within 72 hours of enrollment. * Any active ulcerative keratitis, specifically any epithelial loss greater than punctate keratitis * Participation in an ophthalmic drug or device research study within the 30 days prior to entry in this study. * Subjects who were immune compromised.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Resolution of Baseline Bacterial Conjunctivitis (Day 8 or 9) | Visit 3 - day 8 or 9 | Resolution of conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection. |
| Eradication of Baseline Pathogens (Day 8 or 9) | Visit 3 - Day 8 or day 9 | Bacterial species eradication of baseline bacterial infection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Resolution of Baseline Bacterial Conjunctivitis Day 4 (+/- 1 Day) | Visit 2 - Day 4 (+/- 1 day) | The absence of conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection. |
| Eradication of Baseline Pathogens Day 4 (+/- 1 Day) | Visit 2 - Day 4 (+/- 1 day) | Bacterial species eradication of baseline bacterial infection |
Participant flow
Recruitment details
Study was started on 12/28/04 and last patient last visit was 6/7/05. This study took place at 35 centers in the US.
Pre-assignment details
270 subjects were enrolled, 269 were randomized(1 subject refused culture), 118 of which had bacteriologically confirmed acute bacterial conjunctivitis at baseline.
Participants by arm
| Arm | Count |
|---|---|
| ISV-403 0.6% ISV-403 | 137 |
| Vehicle Vehicle of ISV-403 | 132 |
| Total | 269 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lack of Efficacy | 1 | 7 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Refusal | 0 | 1 |
| Overall Study | Termination by study sponser | 0 | 1 |
Baseline characteristics
| Characteristic | Vehicle | ISV-403 | Total |
|---|---|---|---|
| Age, Continuous | 35.1 years STANDARD_DEVIATION 22.4 | 33.3 years STANDARD_DEVIATION 22.3 | 34.2 years STANDARD_DEVIATION 22.3 |
| Age, Customized 20 to 59 Years | 71 Participants | 71 Participants | 142 Participants |
| Age, Customized 2 to 19 Years | 37 Participants | 44 Participants | 81 Participants |
| Age, Customized < 2 years | 1 Participants | 2 Participants | 3 Participants |
| Age, Customized >/=60 Years | 23 Participants | 20 Participants | 43 Participants |
| Race/Ethnicity, Customized Asian | 2 participants | 2 participants | 4 participants |
| Race/Ethnicity, Customized Black or African American | 11 participants | 6 participants | 17 participants |
| Race/Ethnicity, Customized Caucasian | 106 participants | 116 participants | 222 participants |
| Race/Ethnicity, Customized Hispanic | 8 participants | 12 participants | 20 participants |
| Race/Ethnicity, Customized Other | 5 participants | 1 participants | 6 participants |
| Sex: Female, Male Female | 76 Participants | 86 Participants | 162 Participants |
| Sex: Female, Male Male | 56 Participants | 51 Participants | 107 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 45 / 137 | 46 / 132 |
| serious Total, serious adverse events | 1 / 137 | 1 / 132 |
Outcome results
Primary
Clinical Resolution of Baseline Bacterial Conjunctivitis (Day 8 or 9)
Resolution of conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection.
Time frame: Visit 3 - day 8 or 9
Population: Intent to treat population, culture confirmed. Missing values and discontinued patients imputed as failures.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ISV-403 | Clinical Resolution of Baseline Bacterial Conjunctivitis (Day 8 or 9) | 37 Participants |
| Vehicle | Clinical Resolution of Baseline Bacterial Conjunctivitis (Day 8 or 9) | 20 Participants |
Primary
Eradication of Baseline Pathogens (Day 8 or 9)
Bacterial species eradication of baseline bacterial infection
Time frame: Visit 3 - Day 8 or day 9
Population: Intent to treat population, culture confirmed. Missing values and discontinued patients imputed as failures.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ISV-403 | Eradication of Baseline Pathogens (Day 8 or 9) | 54 Participants |
| Vehicle | Eradication of Baseline Pathogens (Day 8 or 9) | 38 Participants |
Secondary
Clinical Resolution of Baseline Bacterial Conjunctivitis Day 4 (+/- 1 Day)
The absence of conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection.
Time frame: Visit 2 - Day 4 (+/- 1 day)
Population: Intent to treat population, culture confirmed. Missing values and discontinued patients imputed as failures.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ISV-403 | Clinical Resolution of Baseline Bacterial Conjunctivitis Day 4 (+/- 1 Day) | 14 Participants |
| Vehicle | Clinical Resolution of Baseline Bacterial Conjunctivitis Day 4 (+/- 1 Day) | 8 Participants |
Secondary
Eradication of Baseline Pathogens Day 4 (+/- 1 Day)
Bacterial species eradication of baseline bacterial infection
Time frame: Visit 2 - Day 4 (+/- 1 day)
Population: Intent to treat population, culture confirmed. Missing values and discontinued patients imputed as failures.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ISV-403 | Eradication of Baseline Pathogens Day 4 (+/- 1 Day) | 54 Participants |
| Vehicle | Eradication of Baseline Pathogens Day 4 (+/- 1 Day) | 28 Participants |