Bacterial Conjunctivitis
Conditions
Keywords
Bacterial Conjunctivitis, Pink Eye, Conjunctivitis, Eye Infection, Eye Discharge
Brief summary
The purpose of this study is to evaluate the clinical and microbial efficacy and safety of AzaSite compared to vehicle for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye may be eligible. Subjects will be randomly assigned to receive either 1.0 % AzaSite or Vehicle. Three visits will be required for this study.
Interventions
DRUGAzaSite
1.0% AzaSite contains 1.0% azithromycin, sodium hydroxide, mannitol, poloxamer 407, citric acid anhydrous, sodium citrate, DuraSite® (polycarbophil, sodium chloride, EDTA disodium and water for injection) and benzalkonium chloride 0.003%. AzaSite was prescribed as a single topical drop to the infected eye(s) for 5 days, twice on the first two days (once in the morning and at bedtime) and once a day in the morning (between 7-10 AM) for the following three days.
OTHERVehicle
Vehicle contains sodium hydroxide, mannitol, poloxamer 407, citric acid anhydrous, sodium citrate, DuraSite® (polycarbophil, sodium chloride, EDTA disodium and water for injection) and benzalkonium chloride 0.003%. Vehicle was prescribed as a single topical drop to the infected eye(s) for 5 days, twice on the first two days (once in the morning and at bedtime) and once a day in the morning (between 7-10 AM) for the following three days.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Months to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female subject, of any race, who is at least 1 year of age. * Subjects must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit mucopurulent or purulent conjunctival discharge (crusty or sticky eyelids, globular and yellow discharge) and redness in at least one eye. * The symptoms of bacterial conjunctivitis must be present for 3 days (approximately 72 hours) or less. * Must be willing to discontinue contact lens wear for the duration of the study.
Exclusion criteria
* Any uncontrolled, systemic, debilitating disease. * Use of topical ophthalmic solutions including tear substitutes within 2 hours before and during the study. * Use of any topical ophthalmic anti-inflammatory agents within 48 hours before and during the study. * Any active upper respiratory tract infection. * Pregnant or nursing females. * Use of any antibiotic (topical or systemic) within 72 hours of enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants Who Achieved Clinical Resolution | Visit 3 (Days 6-7) | Clinical Resolution is defined as absence of all three clinical signs: ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants Who Achieved Bacteriological Eradication | Visit 3 (Day 6-7) | Bacterial eradication is defined as the eradication of the causative pathogens as indicated by the absence of growth (0 colony forming units/mL) of the original infecting organism(s). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AzaSite Per protocol population defined as all randomized participants who had administered at least one drop of study drug, who had eye cultures indicating pathogenic bacteria levels as well as the clinical signs of conjunctivitis at Visit 1 and had at least one post first dose clinical assessment. | 130 |
| Vehicle Per protocol population defined as all randomized participants who had administered at least one drop of study drug, who had eye cultures indicating pathogenic bacteria levels as well as the clinical signs of conjunctivitis at Visit 1 and had at least one post first dose clinical assessment. | 149 |
| Total | 279 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 5 |
| Overall Study | Lack of Efficacy | 7 | 15 |
| Overall Study | Lost to Follow-up | 5 | 1 |
| Overall Study | Other Reason | 0 | 2 |
| Overall Study | Protocol Violation | 1 | 4 |
| Overall Study | Treatment unmasked | 1 | 0 |
| Overall Study | Withdrawal by Subject | 6 | 6 |
Baseline characteristics
| Characteristic | AzaSite | Vehicle | Total |
|---|---|---|---|
| Age Continuous | 25.6 years STANDARD_DEVIATION 24.49 | 30.8 years STANDARD_DEVIATION 28.07 | 28.4 years STANDARD_DEVIATION 26.54 |
| Sex: Female, Male Female | 82 Participants | 78 Participants | 160 Participants |
| Sex: Female, Male Male | 48 Participants | 71 Participants | 119 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 333 | 0 / 350 |
| serious Total, serious adverse events | 0 / 333 | 2 / 350 |
Outcome results
Primary
Participants Who Achieved Clinical Resolution
Clinical Resolution is defined as absence of all three clinical signs: ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection.
Time frame: Visit 3 (Days 6-7)
Population: Per protocol population (defined as all randomized participants who had administered at least one drop of study drug, who had eye cultures indicating pathogenic bacteria levels as well as the clinical signs of conjunctivitis at Visit 1 and had at least one post first dose clinical assessment) with last observation carried forward.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AzaSite | Participants Who Achieved Clinical Resolution | 82 Participants |
| Vehicle | Participants Who Achieved Clinical Resolution | 74 Participants |
Secondary
Participants Who Achieved Bacteriological Eradication
Bacterial eradication is defined as the eradication of the causative pathogens as indicated by the absence of growth (0 colony forming units/mL) of the original infecting organism(s).
Time frame: Visit 3 (Day 6-7)
Population: Per protocol population (defined as all randomized participants who had administered at least one drop of study drug, who had eye cultures indicating pathogenic bacteria levels as well as the clinical signs of conjunctivitis at Visit 1 and had at least one post first dose clinical assessment) with last observation carried forward.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AzaSite | Participants Who Achieved Bacteriological Eradication | 115 Participants |
| Vehicle | Participants Who Achieved Bacteriological Eradication | 99 Participants |