Conditions: Allergic Conjunctivitis
Keywords: Allergic conjunctivitis Olopatadine HCl solution Conjunctival Allergen Challenge Itching eyes Ocular allergies PATADAY PATANOL
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 902
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate an ophthalmic solution for the treatment of ocular itching associated with allergic conjunctivitis using the Conjunctival Allergen Challenge (CAC) model.

Detailed description:
Enrolled participants will be tested for the presence of common allergies using the Conjunctival Allergen Challenge (CAC) model. Drops of increasing concentration of a solubilized allergen will be instilled in both eyes until a positive reaction occurred. The test will be repeated to confirm the allergic reaction. Participants with confirmed reactions will be administered the test article (Day 0) and undergo a CAC 24 hours post-instillation (Day 1). On Day 14, participants will be administered the test article and undergo an additional CAC.

Arms:
arm 1: AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14 arm 2: Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14 arm 3: Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14 arm 4: AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14

Interventions: intervention 1: AL-4943A ophthalmic solution intervention 2: Olopatadine hydrochloride ophthalmic solution, 0.2% intervention 3: Olopatadine hydrochloride ophthalmic solution, 0.1% intervention 4: AL-4943A ophthalmic solution vehicle
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol document: