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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01001091 | AL-38583 Ophthalmic Solution for Allergic Conjunctivitis Associated Inflammation | PHASE2 | COMPLETED | 312 | — | — | Dec 1, 2009 | Apr 1, 2010 | Jul 17, 2014 | - | — |
| Arm | Type | Description |
|---|---|---|
| AL-38583 0.01% | EXPERIMENTAL | AL-38583 ophthalmic solution, 1 drop instilled in each eye 3 times per day for 2 weeks |
| AL-38583 0.05% | EXPERIMENTAL | AL-38583 ophthalmic solution, 1 drop instilled in each eye 3 times per day for 2 weeks |
| AL-38583 0.2% | EXPERIMENTAL | AL-38583 ophthalmic solution, 1 drop instilled in each eye 3 times per day for 2 weeks |
| AL-38583 Vehicle | PLACEBO_COMPARATOR | AL-38583 ophthalmic solution vehicle, 1 drop instilled in each eye 3 times per day for 2 weeks |
| MAXIDEX | ACTIVE_COMPARATOR | Dexamethasone ophthalmic suspension, 0.1%, 1 drop instilled in each eye 3 times per day for 2 weeks |
| Name | Type | Description |
|---|---|---|
| AL-38583 ophthalmic solution | DRUG | - |
| AL-38583 ophthalmic solution vehicle | DRUG | Inactive ingredients used as a placebo comparator |
| Dexamethasone ophthalmic suspension, 0.1% | DRUG | - |
Inclusion Criteria: * Presence of signs and symptoms of ocular inflammation in both eyes. * Have a positive CAC response at Visit 1. * Able to avoid the use of disallowed medications as well as contact lens wear for the specified period prior to Visit 1, and for the duration of the study. * Other p...