Safety and Efficacy Study of AL-53817 and AL-78843 Ophthalmic Solutions for Allergic Conjunctivitis

Inclusion Criteria:

- Sign Informed Consent

- Use of condom by sexually active males for the entire duration of the study;

- Best corrected visual acuity of 55 or greater in each eye as measured by ETDRS
(letters read method).

- Able and willing to comply with study protocol and follow protocol instructions.

- Able to avoid any of the topical ocular or systemic excluded medications during the
entire study period.

- At least 1 year subject-reported or physician-diagnosed history (prior to Screen
Visit) of allergic conjunctivitis during the ragweed season.

- Positive skin prick test for short ragweed allergen within 12 months prior to Screen
Visit.

- Significant staff-assessed ocular redness in at least one region in each eye within
the 3 hour period of allergen exposure in the EEC (Screen Visits).

- Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

- Women of childbearing potential, defined as all women physiologically capable of
becoming pregnant, unless they are using highly effective methods of contraception
during dosing and for at least 1 week following the last dose of investigational
product.

- Presence of any ocular infection, history of ocular Herpes (simplex or zoster) or
adenoviral infection in either eye.

- History of any ocular infection, physician or subject diagnosed, within 30 days prior
to Screen Visit.

- Presence of glaucoma, past history of, or diagnosis of glaucoma or ocular
hypertension.

- Presence of blepharitis, active rosacea affecting the ocular adnexa, meibomian gland
dysfunction, follicular conjunctivitis, intraocular inflammation, or preauricular
lymphadenopathy or any other ophthalmic abnormality that may affect the study
outcomes.

- Corneal conditions affecting the corneal structure.

- Unwilling to discontinue contact lens wear during the study period.

- Any ocular surgery including ocular laser procedures within 1 year prior to Screen
Visit.

- Current or recent (<6 months prior to Screen Visit) history of severe, unstable, or
uncontrolled autoimmune, neurological, cardiovascular, hematological, hepatic, renal,
psychological, respiratory, gastrointestinal and/or immunological disease or evidence
of other diseases based upon a review of medical history and/or physical examination
that, in the opinion of the Investigator, would preclude safe subject participation
in the study.

- Receiving treatment for anxiety and/or depression at the Screen Visit; any history of
suicide attempt.

- Participation in any investigational study within 30 days of Screen Visit or
concomitantly with this study.

- Known contraindications or hypersensitivities to any of the study medications or
their components

- Confirmed (by physician or optometrist) diagnosis of dry eye.

- History of sensitivity or adverse reaction to steroids.

- Known allergic reaction that is unresponsive to corticosteroids or non-steroidal
anti-inflammatory drugs (NSAIDS).

- Physician diagnosed asthma (except inactive childhood asthma and exercise-induced
asthma).

- Evidence of active inflammation in the eye as determined by the dilated fundus
examination conducted at Screen C Visit.

- Any corneal swelling or haze as determined by the slitlamp examination conducted at
Screen C Visit.

- Other protocol-defined exclusion criteria may apply.