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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00586625 | Safety Study for Bepotastine Besilate Ophthalmic Solution in Normal Volunteers | PHASE3 | COMPLETED | 861 | — | — | Oct 1, 2007 | - | Feb 15, 2013 | - | — |
A 4-step grading scale with half unit (1-step) increments allowed: 0=Comfortable;discomfort absent; 1.0=Generally comfortable; mild discomfort; 2.0=Some discomfort but tolerable; moderate comfort; 3.0=Severely uncomfortable or intolerable
| Arm | Type | Description |
|---|---|---|
| Bepreve | EXPERIMENTAL | bepotastine besilate ophthalmic solution 1.5% |
| Placebo | PLACEBO_COMPARATOR | vehicle |
| Name | Type | Description |
|---|---|---|
| Bepreve | DRUG | One drop, both eyes, twice a day |
| Placebo | DRUG | One drop, both eyes, twice a day |
Inclusion Criteria: * Subjects must be at least 3 years of age, and have ocular health within normal limits Exclusion Criteria: * No active ocular disease