Conjunctivitis, Bacterial
Conditions
Brief summary
This is a multi-center, open-label, single dose/multiple dose, pharmacokinetic study in participants with bacterial conjunctivitis. The purpose of this study is to determine the extent of systemic exposure to BOL-303224-A following single and multiple topical administration of BOL-303224-A in participants with suspected bacterial conjunctivitis.
Interventions
DRUGBOL-303224-A
1 drop in each eye, TID for 5 days at approximately 6 h intervals, with a final, single dose on the morning of Visit 7 (Day 6).
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* must be at least 18 years of age, any race * must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in both eyes * women of childbearing potential must utilize reliable contraceptive methods and have a negative pregnancy test
Exclusion criteria
* Pregnant or nursing women * known hypersensitivity to fluoroquinolones or to any of the ingredients in the study medication * use of any antibiotic within 72 hours of enrollment * participation in an ophthalmic drug or devise research study within 30 days prior to entry in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of systemic pharmacokinetics following a single dose and steady-state pharmacokinetics after multiple TID dosing | Blood samples will be collected from 0 to 6 hours on Day 1 and from 0 to 12 hours on Day 6. There will be additional sampling times at 0 hours on Day 2-5. |
Secondary
| Measure | Time frame |
|---|---|
| Investigator ratings of ocular discharge and bulbar conjunctival injection, Visual Acuity, ophthalmoscopy findings and Adverse event collection | Througout the study |
Countries
United States
Outcome results
None listed