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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01291108 | Safety and Efficacy of AGN-210669 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension | PHASE2 | COMPLETED | 125 | — | — | Apr 1, 2011 | Oct 1, 2011 | Nov 6, 2013 | 1 | United States |
| NCT01001195 | Safety and Efficacy of Three Formulations of AGN-210669 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution | PHASE2 | COMPLETED | 165 | — | — | Nov 1, 2009 | Apr 1, 2010 | Oct 18, 2013 | 1 | United States |
IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes are used for the analyses. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). Data are recorded at Hours 0, 4, 8, and 12.
IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes is used for the analyses. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening).
| Arm | Type | Description |
|---|---|---|
| AGN-210669 | EXPERIMENTAL | AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1. |
| AGN-210669 + bimatoprost | EXPERIMENTAL | AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% applied as 1 drop of each treatment in both eyes every evening during Month 2. |
| AGN-210669 + bimatoprost vehicle | EXPERIMENTAL | AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2. |
| bimatoprost | ACTIVE_COMPARATOR | bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1. |
| bimatoprost + AGN-210669 | EXPERIMENTAL | bimatoprost ophthalmic solution 0.03% + AGN-210669 0.05% applied as 1 drop of each treatment in both eyes every evening during Month 2. |
| bimatoprost + bimatoprost vehicle | OTHER | bimatoprost ophthalmic solution 0.03% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2. |
| AGN-210669 ophthalmic solution, 0.1% | EXPERIMENTAL | One drop of AGN-210669 ophthalmic solution, 0.1% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29. |
| AGN-210669 ophthalmic solution, 0.075% | EXPERIMENTAL | One drop of AGN-210669 ophthalmic solution, 0.075% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29. |
| AGN-210669 ophthalmic solution, 0.05% | EXPERIMENTAL | One drop of AGN-210669 ophthalmic solution, 0.05% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29. |
| bimatoprost ophthalmic solution 0.03% | ACTIVE_COMPARATOR | One drop of bimatoprost ophthalmic solution 0.03% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29. |
| Name | Type | Description |
|---|---|---|
| AGN-210669 | DRUG | AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1 or Month 2. |
| bimatoprost | DRUG | bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1 or Month 2. |
| bimatoprost vehicle | DRUG | bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop in both eyes every evening during Month 2. |
| AGN-210669 ophthalmic solution, 0.1% | DRUG | One drop of AGN-210669 ophthalmic solution, 0.1% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29. |
| AGN-210669 ophthalmic solution, 0.075% | DRUG | One drop of AGN-210669 ophthalmic solution, 0.075% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29. |
| AGN-210669 ophthalmic solution, 0.05% | DRUG | One drop of AGN-210669 ophthalmic solution, 0.05% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29. |
| bimatoprost ophthalmic solution 0.03% | DRUG | One drop of bimatoprost ophthalmic solution 0.03% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29. |
Inclusion Criteria: * Diagnosis of primary open-angle glaucoma or ocular hypertension in each eye * Requires bilateral treatment with an IOP-lowering medication * Best corrected visual acuity of 20/100 or better in each eye Exclusion Criteria: * Use of oral, intramuscular, intravenous or topical ...