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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01528111 | Study to Evaluate the Safety, Tolerability, and Efficacy of LX7101 in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension | PHASE1 | COMPLETED | 63 | — | — | Mar 1, 2012 | Jun 1, 2012 | Sep 14, 2015 | 5 | United States |
| Arm | Type | Description |
|---|---|---|
| Low dose LX7101 | EXPERIMENTAL | Days 1-3: once daily dose in study eye (eye with highest IOP); Days 4-7: once daily dose in study eye (eye with highest IOP) and fellow eye (other eye); Days 8-14: twice daily dose in study eye (eye with highest IOP) and fellow eye (other eye) |
| High dose LX7101 | EXPERIMENTAL | Days 1-3: once daily dose in study eye (eye with highest IOP); Days 4-7: once daily dose in study eye (eye with highest IOP) and fellow eye (other eye); Days 8-14: twice daily dose in study eye (eye with highest IOP) and fellow eye (other eye) |
| LX7101 Vehicle | PLACEBO_COMPARATOR | Days 1-3: once daily dose in study eye (eye with highest IOP); Days 4-7: once daily dose in study eye (eye with highest IOP) and fellow eye (other eye); Days 8-14: twice daily dose in study eye (eye with highest IOP) and fellow eye (other eye) |
| Name | Type | Description |
|---|---|---|
| LX7101 (0.125%) | DRUG | Subjects will receive 0.125% LX7101 |
| LX7101 (0.25%) | DRUG | Subjects will receive 0.25% LX7101 |
| LX7101 Vehicle | DRUG | Subjects will receive vehicle |
Inclusion Criteria: * Adults ≥18 years of age * Documented diagnosis of POAG or OHT, in both eyes * Willing and able to provide written informed consent Exclusion Criteria: * History of any form of glaucoma in either eye, other than POAG * Subjects who are unwilling or unable to discontinue conta...