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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01026831 | Preservative-Free MK2452 (Tafluprost) for Open-Angle Glaucoma/Ocular Hypertension (MK2452-001)(COMPLETED) | PHASE3 | COMPLETED | 643 | — | — | Jan 6, 2010 | Sep 17, 2010 | Jun 21, 2017 | - | — |
IOP was measured using a Goldmann applanation tonometer. The primary evaluation was based on the study eye (the worse eye based on the 0800 hour IOP baseline or the right eye when both eyes had the same IOP). IOP change from baseline was calculated using the baseline IOP at each time point (0800 hours at baseline to 0800 hours at Week 2, 6, and 12; 1000 hours at baseline to 1000 hours at Week 2, 6, and 12; 1600 hours at baseline to 1600 hours at Week 2, 6, and 12). Lowering elevated IOP is a treatment goal of glaucoma.
| Arm | Type | Description |
|---|---|---|
| Tafluprost | EXPERIMENTAL | Preservative-free tafluprost |
| timolol maleate | ACTIVE_COMPARATOR | Preservative-free timolol maleate |
| Name | Type | Description |
|---|---|---|
| Preservative-Free Tafluprost | DRUG | One drop of preservative-free vehicle per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for 12 weeks |
| Comparator: timolol | DRUG | One drop of preservative-free timolol maleate (0.5%) per eye twice daily for 12 weeks |
Inclusion Criteria: * Patient has been diagnosed with primary open-angle glaucoma, pigmentary glaucoma, capsular glaucoma/pseudoexfoliation, or ocular hypertension * Patient has a mean (or median) IOP of \>=23 and =\<36 in at least one eye at the 0800 hours time point at the Baseline Visit. * Patie...
| 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 |