Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01175590 | Safety of Besivance™ (Besifloxacin Ophthalmic Suspension) 0.6% Compared to Vehicle | PHASE3 | COMPLETED | 518 | — | — | Jun 1, 2010 | Feb 1, 2012 | May 1, 2013 | 1 | United States |
Ocular Treatment-Emergent Adverse Events on the Study Eye
Non-Ocular Treatment-Emergent Adverse Events on the Study Eye
| Arm | Type | Description |
|---|---|---|
| Besivance | EXPERIMENTAL | besifloxacin ophthalmic suspension 0.6% |
| Vehicle | PLACEBO_COMPARATOR | Vehicle of Besivance |
| Name | Type | Description |
|---|---|---|
| Besivance | DRUG | Ocular administration to affected eye for 7 days |
| Vehicle | DRUG | Vehicle of Besivance administered to affected eye for 7 days |
Inclusion Criteria: * Subjects 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. * Subjects who are willing to discontinue contact lens wear for the duration of the study. * Subjec...