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

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 occurs. 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 during the period indicated prior to Visit 1.

- Other protocol-defined exclusion criteria may apply.