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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02743780 | A Three Part Study of MGV354 in Ocular Hypertension or Glaucoma | PHASE1 | COMPLETED | 191 | — | — | Mar 2, 2016 | Sep 20, 2016 | Jul 2, 2018 | - | — |
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. Diurnal IOP was defined as the average of the five time points measured (8 AM, 10 AM, noon, 4 PM, and 8 PM). Baseline diurnal IOP was the average of IOP measurements obtained at the 2 eligibility visits. Change from baseline was calculated by taking the change at each time point from baseline to Day 8 and averaging the available changes. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye (study eye) contributed to the analysis.
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. Baseline IOP was the average of IOP measurements obtained at the 2 eligibility visits. Change from baseline was calculated by taking the change at each time point from baseline to Day 8. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye (study eye) contributed to the analysis.
| Arm | Type | Description |
|---|---|---|
| MGV354 | EXPERIMENTAL | Part 3: MGV354 ophthalmic suspension, 1 drop in both eyes once per day for 7 days |
| Placebo | PLACEBO_COMPARATOR | Part 3: MGV354 placebo, 1 drop in both eyes once per day for 7 days |
| Name | Type | Description |
|---|---|---|
| MGV354 ophthalmic suspension | DRUG | - |
| MGV354 placebo | DRUG | Inactive ingredients used as placebo comparator |
Inclusion Criteria: * Documented informed consent. * Part 1: 18 to 70 years of age; * Parts 2 and 3: 18 years of age or older; * Able to communicate well with the investigator and understand and comply with the requirements of the study; * Body Mass Index (BMI) between 18 and 39; * In case of conta...
| 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 |