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AGN-229666 · 3 trials · 2 indications
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.
The participant evaluated ocular itching in both eyes 5 minutes post conjunctival allergen challenge (CAC) (8 hours post-dose) at Day 1 using a 9-point scale in half-unit increments where: 0=none to 4=incapacitating itch with an irresistible urge to rub. The score for each participant was the average of the score of both eyes.
| 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. |
| AGN-229666 Dose A | EXPERIMENTAL | One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15. |
| AGN-229666 Dose B | EXPERIMENTAL | One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15. |
| vehicle of AGN-229666 | PLACEBO_COMPARATOR | One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 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. |
| vehicle of AGN-229666 | OTHER | One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 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.
AGN-229666 is an investigational ophthalmic small molecule developed for the treatment of allergic conjunctivitis, including seasonal and perennial forms. It is formulated as an ophthalmic solution and has been studied in patients with allergic conjunctivitis in Japan.
AGN-229666 is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. The company has sponsored Phase 2 and Phase 3 clinical trials of the ophthalmic solution in patients with allergic conjunctivitis.
AGN-229666 has completed Phase 3 clinical development. Three trials have been conducted in total, including two Phase 3 studies and one Phase 2 study, all of which are now completed. No active trials of AGN-229666 are currently listed.
AGN-229666 has been evaluated in three completed trials: NCT02161146, a Phase 3 study in Japanese patients with allergic conjunctivitis; NCT02082262, a Phase 3 study in seasonal or perennial allergic conjunctivitis; and NCT01754766, a Phase 2 study in allergic conjunctivitis.
Across the three completed clinical trials, 470 patients were enrolled in total. The Phase 3 study NCT02161146 enrolled 240 patients, the Phase 3 study NCT02082262 enrolled 140 patients, and the Phase 2 study NCT01754766 enrolled 90 patients.
Yes. The AGN-229666 clinical program used randomized, double-blind, placebo-controlled designs. All three trials were conducted in Japan and enrolled patients with allergic conjunctivitis, including both seasonal and perennial forms.