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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02161146 | AGN-229666 Ophthalmic Solution in Japanese Patients With Allergic Conjunctivitis | PHASE3 | COMPLETED | 240 | — | — | Jun 4, 2014 | Dec 20, 2014 | Apr 17, 2019 | 1 | Japan |
| NCT02082262 | AGN-229666 Ophthalmic Solution for the Treatment of Seasonal or Perennial Allergic Conjunctivitis | PHASE3 | COMPLETED | 140 | — | — | Mar 1, 2014 | Jul 1, 2014 | Mar 14, 2016 | 1 | Japan |
Ocular itching was assessed by the participant 8 hours after AGN-229666 and vehicle administration and 4 hours after olopatadine administration, 5 minutes post allergen challenge using a 0 to 4 scale with 0.5 grade increments where: 0=none (no itching) to 4.0=incapacitating itch with an irresistible urge to rub (worst). Data from Days 1 and 15 were pooled together and averaged.
Ocular itching frequency is assessed on a 6-poing scale, where 0 = did not occur, 1 = once in 3 days, 2 = twice in 3 days, 3 = once every day, 4 = 2 or more times every day, and 5 = virtually all the time over the past 3 days. Ocular itching frequency is evaluated over the 3 days prior to the visit. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
| Arm | Type | Description |
|---|---|---|
| AGN-229666 | EXPERIMENTAL | One drop of AGN-229666 in each eye on Days 1 and 15. |
| Vehicle | PLACEBO_COMPARATOR | One drop of Vehicle to AGN-229666 in each eye on Days 1 and 15. |
| Olopatadine | ACTIVE_COMPARATOR | One drop of olopatadine in each eye on Days 1 and 15. |
| AGN-229666/Olopatadine | OTHER | One drop of AGN-229666 in one eye and one drop of olopatadine in the other eye on Days 1 and 15. |
| AGN-229666/Vehicle | OTHER | One drop of AGN-229666 in one eye and one drop of Vehicle to AGN-229666 in the other eye on Days 1 and 15. |
| Name | Type | Description |
|---|---|---|
| AGN-229666 | DRUG | One drop of AGN-229666 in the eye on Days 1 and 15. |
| Vehicle to AGN-229666 | DRUG | One drop of Vehicle to AGN-229666 in the eye on Days 1 and 15. |
| Olopatadine | DRUG | One drop of olopatadine in the eye on Days 1 and 15. |
Inclusion Criteria: -Japanese patients living in Japan with a history of allergic conjunctivitis. Exclusion Criteria: * Presence of active eye infection (bacterial, viral, or fungal) * History of an eye herpetic infection.