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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00347932 | A Study to Determine if 0.6% ISV-403 is Safe and Effective in the Treatment of Bacterial Conjunctivitis. | PHASE3 | COMPLETED | 957 | — | — | Jun 1, 2006 | Nov 1, 2007 | Mar 24, 2015 | - | — |
The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection
Absence (grade 0 on the ordinal scale) of all ocular bacterial species that were present at or above the threshold value for that species from the Cagle list at baseline.
| Arm | Type | Description |
|---|---|---|
| ISV-403 | EXPERIMENTAL | 0.6% ISV-403 ophthalmic suspension |
| Vehicle | PLACEBO_COMPARATOR | Vehicle of ISV-403 ophthalmic suspension |
| Name | Type | Description |
|---|---|---|
| ISV-403 | DRUG | Subjects with bacterial conjunctivitis were randomized to receive 0.6% ISV-403 eye drops three times a day (TID) for 5 days. |
| Vehicle | DRUG | Subjects with bacterial conjunctivitis were randomized to receive vehicle eye drops three times a day (TID) for 5 days. |
Inclusion Criteria: * Must have a diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in at least one eye. * Females of childbearing potential must utilized reliable contraceptive methods and have a negative pregnancy test. Exclusion Criteria: * Pre...