Bacterial Conjunctivitis
Conditions
Keywords
Bacterial Conjunctivitis, Pink Eye, Conjunctivitis, Eye Infection
Brief summary
The purpose of this study is to evaluate the clinical and microbial efficacy and safety of AzaSite compared to tobramycin for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye are eligible. Subjects will be randomly assigned to the AzaSite group or Tobramycin group. Three visits will be required for the study.
Interventions
DRUGAzaSite
AzaSite ophthalmic solution; one topical drop to the infected eye or eyes twice daily (in the morning and at bedtime) on Days 1 and 2 followed by once daily (in the morning between 7 and 10am) on Days 3 through 5.
DRUGTobramycin
Tobramycin ophthalmic solution; one topical drop to the infected eye or eyes four times daily at 4 to 6 hour intervals (first dose in the morning between 7 and 10am) for 5 days.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years 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 disease or 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 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 |
|---|---|---|
| Number of Participants Who Achieved Clinical Resolution at Visit 3 | Visit 3 (Day 6) | 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 |
|---|---|---|
| Number of Participants Who Achieved Bacterial Eradication at Visit 3 | Visit 3 (Day 6) | Bacterial eradication is defined as 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
subjects who had administered at least one drop of the appropriate study drug, demonstrated evidence of
pathogenic bacteria levels, presented clinical signs of conjunctivitis at Visit 1, and returned for at least one post-first dose clinical assessment) with last observation carried forward. | 159 |
| Tobramycin Per protocol population (defined as all randomized
subjects who had administered at least one drop of the appropriate study drug, demonstrated evidence of
pathogenic bacteria levels, presented clinical signs of conjunctivitis at Visit 1, and returned for at least one post-first dose clinical assessment) with last observation carried forward. | 157 |
| Total | 316 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 9 | 8 |
| Overall Study | Lack of Efficacy | 2 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Other Reason | 4 | 0 |
| Overall Study | Protocol Violation | 4 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 3 |
Baseline characteristics
| Characteristic | AzaSite | Tobramycin | Total |
|---|---|---|---|
| Age, Continuous | 17.9 years STANDARD_DEVIATION 20.23 | 22.8 years STANDARD_DEVIATION 22.61 | 20.4 years STANDARD_DEVIATION 21.55 |
| Sex: Female, Male Female | 81 Participants | 90 Participants | 171 Participants |
| Sex: Female, Male Male | 78 Participants | 67 Participants | 145 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 365 | 0 / 378 |
| serious Total, serious adverse events | 0 / 365 | 0 / 378 |
Outcome results
Primary
Number of Participants Who Achieved Clinical Resolution at Visit 3
Clinical resolution is defined as absence of all three clinical signs (ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection).
Time frame: Visit 3 (Day 6)
Population: Per protocol population (defined as all randomized~subjects who had administered at least one drop of the appropriate study drug, demonstrated evidence of~pathogenic bacteria levels, presented clinical signs of conjunctivitis at Visit 1, and returned for at least one post-first dose clinical assessment) with last observation carried forward.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AzaSite | Number of Participants Who Achieved Clinical Resolution at Visit 3 | 127 Participants |
| Tobramycin | Number of Participants Who Achieved Clinical Resolution at Visit 3 | 123 Participants |
Secondary
Number of Participants Who Achieved Bacterial Eradication at Visit 3
Bacterial eradication is defined as 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)
Population: Per protocol population (defined as all randomized~subjects who had administered at least one drop of the appropriate study drug, demonstrated evidence of~pathogenic bacteria levels, presented clinical signs of conjunctivitis at Visit 1, and returned for at least one post-first dose clinical assessment) with last observation carried forward.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AzaSite | Number of Participants Who Achieved Bacterial Eradication at Visit 3 | 140 Participants |
| Tobramycin | Number of Participants Who Achieved Bacterial Eradication at Visit 3 | 148 Participants |