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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01670266 | Single and Multiple Dose Escalation and Two-sequence Crossover Study of ONO-9054 in Patients With Ocular Hypertension or Mild Open-angle Glaucoma | PHASE1 | COMPLETED | 60 | — | — | Aug 1, 2012 | - | Jun 3, 2013 | 3 | United States |
Safety and tolerability of ONO-9054 will be measured using vital signs, ECGs, laboratory tests, ocular exams, physical examination and incidence/severity of adverse events over a dosing period of up to 14 days
| Arm | Type | Description |
|---|---|---|
| Experimental Arm 1 | EXPERIMENTAL | Experimental Eye drops 3.0 µg/mL QD both eyes on Day 1, 5-18 |
| Experimental Arm 2 | EXPERIMENTAL | Experimental Eye drops 10.0 µg/mL QD both eyes on Day 1, 5-18 |
| Experimental Arm 3 | EXPERIMENTAL | Experimental Eye drop 30.0 µg/mL QD both eyes on day 1, 5-18 |
| Experimental Arm 4 | EXPERIMENTAL | Experimental Eye drop, 2 sequence crossover Cohort \[1 dose; 1-30 µg/mL\]to be determined and placebo |
| Placebo Arm | PLACEBO_COMPARATOR | Matched placebo eye drops dosed in same manner as ONO-9054 |
| Name | Type | Description |
|---|---|---|
| ONO-9054 | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: * Male or female subjects age 18-80 (inclusive) with confirmed diagnosis of OHT or OAG * Confirmed diagnosis of bilateral OHT or chronic open-angle glaucoma * Able to undergo washout of all ocular drugs * An IOP ≥ 22mmHg at 8:00 AM and ≥ 21 mmHg at 10:00 AM in at least one eye; ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 2 | PHASE3 | Bimatoprost, AGN-193408 |
| SpyGlass Pharma, Inc. | SGP | 4 | PHASE3 | Bimatoprost System, Timolol , 0.5% |
| Amneal Pharmaceuticals, Inc. Class A | AMRX | 2 | PHASE3 | Test - Bimatoprost 0.01%, Reference - LUMIGAN, Bimatoprost , 0.01%, LUMIGAN 0.01% |
| Glaukos Corp | GKOS | 1 | — | Travoprost |