Evaluation of the Onset and Duration of Action of RX-10045 in Allergic Conjunctivitis

Allergies are relatively common among the general population. Ocular signs and symptoms
include itching, discomfort, redness, chemosis, tearing, and eyelid swelling. Allergic
reactions can vary from a mild, self-limiting disease, to a debilitating condition that
significantly impairs the quality of life of allergen-sensitive individuals.

Currently approved treatments for ocular allergy reduce the signs and symptoms of the early
phase reaction; however, evidence suggests that many patients suffer from the persistent
late phase reaction. Manifestations of the late phase reaction occur 6 to 24 hours after
allergen exposure and are characterized by an influx of acute inflammatory cells into the
conjunctivae. Administration of anti-inflammatory agents decreases allergy signs and
symptoms in both the early and late phase reactions.

RX-10045 has been shown to be efficacious in multiple pre-clinical dry eye disease models
and in a pre-clinical model of allergic conjunctivitis. The objective of this clinical study
is to assess the safety and efficacy of RX-10045 ophthalmic solution for the treatment of
the signs and symptoms of allergic conjunctivitis induced in the Conjunctival Allergen
Challenge Model of allergic conjunctivitis at 15 minutes and 8 hours after medication
instillation. It is anticipated that RX-10045 has therapeutic potential for the treatment of
allergic conjunctivitis and an acceptable risk-benefit profile.

Inclusion Criteria:

Subjects MUST:

1. Have a positive history of ocular allergies

2. Have a positive bilateral conjunctival allergen challenge (CAC) reaction

Exclusion Criteria:

Subjects MUST NOT:

1. Have known contraindications or sensitivities to study medication or its components

2. Have any ocular condition that, in the opinion of the investigator, could affect the
subject's safety or trial parameters

3. Use a disallowed medication during the period indicated prior to the enrollment or
during the study

4. Be a female who is currently pregnant, planning a pregnancy, lactating, or not using
a medically acceptable form of birth control