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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00061516 | Safety and Efficacy Study of BETAXON 0.5% and AZOPT 1.0% in Pediatric Patients With Glaucoma or Ocular Hypertension | PHASE3 | COMPLETED | 78 | — | — | Jan 1, 2003 | Feb 1, 2006 | Nov 18, 2016 | - | — |
| Arm | Type | Description |
|---|---|---|
| Brinzolamide suspension, 1% | EXPERIMENTAL | Dosed twice daily for 12 weeks |
| Levobetaxolol suspension, 0.5% | EXPERIMENTAL | Dosed twice daily for 12 weeks |
| Name | Type | Description |
|---|---|---|
| BETAXON (levobetaxolol HCl) | DRUG | levobetaxolol suspension, 0.5% |
| AZOPT (brinzolamide) | DRUG | brinzolamide suspension, 1% |
INCLUSION: * Children 5 years old and younger * require treatment for glaucoma or ocular hypertension * vision is 20/80 or better * cup-to-disc ratio of 0.8 or less EXCLUSION: * do not have abnormal fixation * IOP greater than 36 mm Hg * significant retinal disease * penetrating keratoplasty * se...