The objective of this study is to evaluate the safety of Besivance (besifloxacin ophthalmic suspension, 0.6%) compared to vehicle.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
518
Bausch & Lomb, Inc.
Rochester, New York, United States
Ocular Treatment Emergent Adverse Events
Ocular Treatment-Emergent Adverse Events on the Study Eye
Time frame: At each visit - 7 days
Non-Ocular Treatment-Emergent Adverse Events
Non-Ocular Treatment-Emergent Adverse Events on the Study Eye
Time frame: 7 days
Clinical Resolution
The absence of both conjunctival discharge and bulbar conjunctival injection, after seven days of treatment. Participants with non-missing data
Time frame: Day 8 (Visit 2)
Clinical Resolution
The absence of both conjunctival discharge and bulbar conjunctival injection, after seven days of treatment.
Time frame: Day 11 (Visit 3)
Microbial Eradication
The absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after seven days of treatment.
Time frame: Days 8 (Visit 2)
Microbial Eradication
The absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after seven days of treatment.
Time frame: Days 11 (Visit 3)
Microbial Outcome With Clinical Resolution
At each follow-up visit for the accepted ocular bacterial species that were present at or above threshold at baseline
Time frame: Day 8 (Visit 2)
Microbial Outcome With Clinical Resolution
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
At each follow-up visit for the accepted ocular bacterial species that were present at or above threshold at baseline
Time frame: Day 11 (Visit 3)
Individual Clinical Outcomes - Ocular Discharge
ocular conjunctival discharge measured as absent, mild, moderate or severe
Time frame: At day 1 (Vist 1)
Individual Clinical Outcomes - Ocular Discharge
ocular conjunctival discharge measured as absent, mild, moderate or severe
Time frame: At day 8 (Vist 2)
Individual Clinical Outcomes - Ocular Discharge
ocular conjunctival discharge measured as absent, mild, moderate or severe
Time frame: At day 11 (Vist 3)
Individual Clinical Outcomes - Bulbar Injection
Bulbar conjunctival injection measured as normal, mild, moderate or severe
Time frame: At day 1 (Vist 1)
Individual Clinical Outcomes - Bulbar Injection
Bulbar conjunctival injection measured as normal, mild, moderate or severe
Time frame: At day 8 (Vist 2)
Individual Clinical Outcomes - Bulbar Injection
Bulbar conjunctival injection measured as normal, mild, moderate or severe
Time frame: At day 11 (Vist 3)