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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02420730 | Safety, Tolerability and Systemic Pharmacokinetics of AGN-232411 in Healthy Participants and Participants With Dry Eye | PHASE1 | COMPLETED | 77 | — | — | Jun 1, 2015 | Mar 1, 2016 | Jul 14, 2016 | 3 | United States |
| Arm | Type | Description |
|---|---|---|
| Cohort 1A: AGN-232411 Dose A | EXPERIMENTAL | One drop of AGN-232411 topical ophthalmic solution Dose A administered in the study eye once daily for one day, followed by twice daily for 16 days in healthy participants. |
| Cohort 1B: AGN-232411 Dose B | EXPERIMENTAL | One drop of AGN-232411 topical ophthalmic solution Dose B administered in the study eye once daily for one day, followed by twice daily for 16 days in healthy participants if the safety and tolerability of Dose A in Cohort 1A is acceptable. |
| Cohort 1C: AGN-232411 Dose C | EXPERIMENTAL | One drop of AGN-232411 topical ophthalmic solution Dose C administered in the study eye once daily for one day, followed by twice daily for 16 days in healthy participants if the safety and tolerability of Dose B in Cohort 1B is acceptable. |
| Cohort 1: AGN-232411 Vehicle | PLACEBO_COMPARATOR | One drop of Vehicle for AGN-232411 topical ophthalmic solution administered in the study eye once daily for one day, followed by twice daily for 16 days in healthy participants. |
| Cohort 2A: AGN-232411 Dose A | EXPERIMENTAL | One drop of AGN-232411 topical ophthalmic solution Dose A administered in the study eye once daily for one day, followed by twice daily for 27 days in participants with dry eye disease. |
| Cohort 2B: AGN-232411 Dose B | EXPERIMENTAL | One drop of AGN-232411 topical ophthalmic solution Dose B administered in the study eye once daily for one day, followed by twice daily for 27 days in participants with dry eye disease if the safety and tolerability of Dose A in Cohort 2A is acceptable. |
| Cohort 2C: AGN-232411 Dose C | EXPERIMENTAL | One drop of AGN-232411 topical ophthalmic solution Dose C administered in the study eye once daily for one day, followed by twice daily for 27 days in participants with dry eye disease if the safety and tolerability of Dose B in Cohort 2B is acceptable. |
| Cohort 2: AGN-232411 Vehicle | PLACEBO_COMPARATOR | One drop of Vehicle for AGN-232411 topical ophthalmic solution administered to the study eye once daily for one day, followed by twice daily for 27 days in participants with dry eye disease. |
| Name | Type | Description |
|---|---|---|
| AGN-232411 | DRUG | AGN-232411 topical ophthalmic solution |
| AGN-232411 Vehicle | DRUG | Vehicle for AGN-232411 topical ophthalmic solution. |
Inclusion criteria: Stage 1 -Healthy participants. Stage 2 -Participants with the symptoms of dry eye disease. Exclusion criteria: Stage 1 -Known allergies or sensitivities to study medications, fluorescein, or lissamine green Stage 2 * Known allergies or sensitivities to study medications, ...