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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00061542 | Safety and Efficacy Study of BETOPTIC S 0.25% and Timolol Gel-forming Solution 0.25% and 0.5% in Pediatric Patients With Glaucoma or Ocular Hypertension | PHASE3 | COMPLETED | 105 | — | — | Jan 1, 2003 | Nov 1, 2006 | Nov 18, 2016 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Betaxolol | EXPERIMENTAL | Two doses daily for 12 weeks |
| TGFS 0.25% | EXPERIMENTAL | Two doses daily for 12 weeks |
| TGFS 0.5% | EXPERIMENTAL | Two doses daily for 12 weeks |
| Name | Type | Description |
|---|---|---|
| BETOPTIC S (betaxolol HCl) | DRUG | betaxolol HC) |
| Timolol Gel-forming Solution (TGFS) | DRUG | timolol maleate 0.25% and 0.5% |
INCLUSION: * Children 5 years old and younger * require treatment for glaucoma or ocular hypertension * whose vision is 20/80 or better * have a 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 kera...