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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00348348 | A Study to Investigate the Safety and Efficacy of BOL-303224 in the Treatment of Bacterial Conjunctivitis | PHASE3 | COMPLETED | 1,161 | — | — | Jun 1, 2006 | Jul 1, 2007 | Mar 24, 2015 | - | — |
Resolution of conjunctival discharge and bulbar conjunctival injection. (mITT, culture confirmed, as treated)
eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated
| Arm | Type | Description |
|---|---|---|
| Moxifloxacin solution | ACTIVE_COMPARATOR | Moxifloxacin hydrochloride ophthalmic solution 0.5% |
| Besifloxacin Suspension | EXPERIMENTAL | Besifloxacin hydrochloride ophthalmic suspension 0.6% |
| Name | Type | Description |
|---|---|---|
| Besifloxacin | DRUG | Besifloxacin hydrochloride ophthalmic suspension, 0.6% as base, administered TID for 5 days |
| Moxifloxacin solution | DRUG | Moxifloxacin hydrochloride ophthalmic solution 0.5% administered TID for 5 days. |
Inclusion Criteria: * Clinical diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in at least one eye. Exclusion Criteria: * Pregnant or nursing females. * Use of any antibiotic within 72 hours of enrollment. * Any disease conditions that could int...