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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00767793 | A Placebo-Controlled Study of INS117548 Ophthalmic Solution in Subjects With Glaucoma (P08650) | PHASE1 | COMPLETED | 84 | — | — | Sep 1, 2008 | May 1, 2009 | Oct 2, 2015 | - | — |
| Arm | Type | Description |
|---|---|---|
| Arm 1 | PLACEBO_COMPARATOR | One drop in each eye every 12 hours for seven days |
| Arm 2 | EXPERIMENTAL | One drop of Concentration #1 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days |
| Arm 3 | EXPERIMENTAL | One drop of Concentration #2 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days |
| Arm 4 | EXPERIMENTAL | One drop of Concentration #3 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | One drop in each eye every 12 hours for seven days |
| INS117548 | DRUG | One drop of Concentration #1 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days |
Inclusion Criteria: * Have a diagnosis of bilateral ocular hypertension or early primary open angle glaucoma * Have best corrected visual acuity in both eyes of at least +0.5 or better Exclusion Criteria: * Are diagnosed with closed angle glaucoma, exfoliation syndrome or exfoliation glaucoma, an...