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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00449956 | MK0507A Clinical Study in Patients With Glaucoma and Ocular Hypertension (0507A-149)(COMPLETED) | PHASE3 | COMPLETED | 474 | — | — | Mar 12, 2007 | Feb 16, 2008 | Jun 20, 2017 | - | — |
| NCT00546286 | A Study to Evaluate the Effectiveness of Cosopt® as First Line Therapy (MK-0507A-153) | PHASE3 | COMPLETED | 170 | — | — | May 31, 2006 | Aug 23, 2007 | Apr 4, 2017 | - | — |
Change from baseline to 8 weeks in Intraocular Pressure (IOP) assessed 2 hours after ocular instillation (at Hour 2)
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | combination of dorzolamide hydrochloride and timolol maleate |
| 2 | ACTIVE_COMPARATOR | Concomitant use of dorzolamide hydrochloride and timolol maleate |
| 3 | ACTIVE_COMPARATOR | timolol maleate |
| Name | Type | Description |
|---|---|---|
| dorzolamide hydrochloride (+) timolol maleate | DRUG | Dorzolamide hydrochloride 1% + timolol 0.5%, 8-week |
| Comparator: timolol maleate | DRUG | timolol maleate 0.5%, 8-week |
| Comparator: dorzolamide hydrochloride | DRUG | dorzolamide hydrochloride 1%, 8-week |
| Comparator: dorzolamide HCl/timolol maleate + prostaglandin | DRUG | Combination treatment of dorzolamide HCl (2%)/timolol maleate(0.5%) BID for six weeks in patients with open-angle glaucoma or ocular hypertension. For patients not achieving target IOP at 6 weeks, a prostaglandin is added for another 6 weeks. |
Inclusion Criteria: * Patients with glaucoma and ocular hypertension Exclusion Criteria: * History of ocular surgery within 3 months * Administration contradiction to timolol and dorzolamide