Efficacy and Safety of an Ophthalmic Solution in Patients With Allergic Conjunctivitis

Phase 3, Efficacy and Safety Study of AL-4943A Ophthalmic Solution, 0.77% in Patients With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge (CAC) Model

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.

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.

Inclusion Criteria:

• Able to be dosed in both eyes, able and willing to make the required study visits and to follow instructions.
• Negative urine pregnancy test if female of childbearing potential and use adequate birth control throughout the study period.
• Diagnostic skin test indicative of allergy for cat hair, cat dander, grasses, ragweed, dust mite, dog dander, cockroach and/or trees within 24 months prior to Visit 1 or at Visit 1.
• History of seasonal or perennial allergic conjunctivitis for at least 1 year prior to Visit 1.
• Best-corrected visual acuity of 55 or greater in each eye as measured by ETDRS (letters read method).
• Manifest a positive bilateral Conjunctival Allergen Challenge (CAC) test response.
• Willing to discontinue contact lens wear for at least 72 hours prior to Visit 1 and throughout the study.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Known history or presence of persistent dry eye syndrome, or currently requires frequent use of artificial tears, gels or lubricants, presence of punctal plugs, use of Restasis®, or topical ocular corticosteroids for dryness of eyes.
• Presence of an ocular condition that may affect the study outcomes.
• History or evidence of ocular surgery (including refractive procedures such as LASIK, PRK and RK) within 6 months of Visit 1.
• Presence of signs/symptoms of active allergic conjunctivitis at the start of Visits 1, 2, 3A, or 4.
• History of anaphylactic reaction to any allergens used in this study.
• Current evidence or recent (within 6 months) history of severe, unstable, or uncontrolled medical conditions and/or other relevant systemic diseases.
• Use of any disallowed medication without protocol-specified washout period prior to Visit 1, or during the study.
• Other protocol-defined exclusion criteria may apply.