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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01749904 | Comparing Safety and Efficacy of BOL-303259-X With Timolol Maleate in Subjects With Open-Angle Glaucoma or Ocular Hypertension | PHASE3 | COMPLETED | 420 | — | — | Jan 31, 2013 | Sep 30, 2015 | Nov 7, 2018 | 1 | United States |
| NCT01749930 | Comparing the Safety and Efficacy of BOL-303259-X Ophthalmic Solution With Timolol Maleate Ophthalmic Solution in Subjects With Open-Angle Glaucoma or Ocular Hypertension | PHASE3 | COMPLETED | 420 | — | — | Jan 1, 2013 | May 1, 2015 | Nov 21, 2018 | 1 | United States |
Mean intraocular pressure (IOP) in study eye measured at the specified time points: 8 AM, 12 PM, and 4 PM at Visit 4(Week 2), Visit 5 (Week 6), and Visit 6 (Month 3).
| Arm | Type | Description |
|---|---|---|
| BOL-303259-X | EXPERIMENTAL | BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) administered for 3 months (Visit 6) into the study eye(s). |
| Timolol | ACTIVE_COMPARATOR | Timolol maleate ophthalmic solution, 0.5%, administered BID for 3 months (Visit 6) into study eye(s). |
| Name | Type | Description |
|---|---|---|
| BOL-303259-X | DRUG | Topical ocular BOL-303259-X will be administered QD in the evening and its vehicle administered QD in the morning for 3 months (visit 6). |
| Timolol | DRUG | Timolol will be administered BID once in the morning and once in the evening for 3 months (Visit 6) |
Inclusion Criteria: * Participants must have a diagnosis of OAG (including pigmentary or pseudoexfoliative) or OHT in 1 or both eyes. * Participants must meet the following IOP requirements at Visit 3 * mean/median IOP ≥ 24 mmHg at a minimum of 2 time points in the same eye * IOP ≤ 36 mmHg at all 3...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Glaukos Corp | GKOS | 3 | PHASE4 | Travoprost Intraocular |
| Amneal Pharmaceuticals, Inc. Class A | AMRX | 1 | PHASE4 | Test - Bimatoprost 0.01%, Reference - LUMIGAN |
| AbbVie, Inc. | ABBV | 1 | PHASE4 | Bimatoprost |
| United Therapeutics Corporation | UTHR | 1 | PHASE4 | Nicotinomide |
| Alcon AG | ALC | 3 | PHASE4 | Undisclosed |