AGN-229666 Ophthalmic Solution in Japanese Patients With Allergic Conjunctivitis

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and efficacy of AGN-229666 for the prevention of allergen-mediated conjunctivitis.

Conditions
-----------------
Conjunctivitis, Allergic

Intervention / Treatment
-----------------
* Drug: AGN-229666
* Drug: Vehicle to AGN-229666
* Drug: Olopatadine


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AGN-229666<br>One drop of AGN-229666 in each eye on Days 1 and 15. | Drug: AGN-229666<br>* One drop of AGN-229666 in the eye on Days 1 and 15.<br>|
| Placebo Comparator: Vehicle<br>One drop of Vehicle to AGN-229666 in each eye on Days 1 and 15. | Drug: Vehicle to AGN-229666<br>* One drop of Vehicle to AGN-229666 in the eye on Days 1 and 15.<br>|
| Active Comparator: Olopatadine<br>One drop of olopatadine in each eye on Days 1 and 15. | Drug: Olopatadine<br>* One drop of olopatadine in the eye on Days 1 and 15.<br>* Other names: Patanol®;|
| Other: AGN-229666/Olopatadine<br>One drop of AGN-229666 in one eye and one drop of olopatadine in the other eye on Days 1 and 15. | Drug: AGN-229666<br>* One drop of AGN-229666 in the eye on Days 1 and 15.<br>Drug: Olopatadine<br>* One drop of olopatadine in the eye on Days 1 and 15.<br>* Other names: Patanol®;|
| Other: AGN-229666/Vehicle<br>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. | Drug: AGN-229666<br>* One drop of AGN-229666 in the eye on Days 1 and 15.<br>Drug: Vehicle to AGN-229666<br>* One drop of Vehicle to AGN-229666 in the eye on Days 1 and 15.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Itching Score | 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. | Days 1 and 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conjunctival Hyperemia Score | Hyperemia is the engorgement of the blood vessels (redness) of the eye. Ocular hyperemia was evaluated by the investigator 8 hours after AGN-229666 and vehicle administration and 4 hours after olopatadine administration, 15 minutes post allergen challenge using a 0 to 4 scale with 0.5 grade increments where: 0=none (no hyperemia) to 4.0=extremely severe (large, numerous dilated blood vessels characterized by severe deep red color). Data from Days 1 and 15 were pooled together and averaged. | Days 1 and 15 |