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:

• Have a positive history of ocular allergies
• Have a positive bilateral conjunctival allergen challenge (CAC) reaction

Exclusion criteria

Subjects MUST NOT:

• Have known contraindications or sensitivities to study medication or its components
• Have any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters
• Use a disallowed medication during the period indicated prior to the enrollment or during the study
• Be a female who is currently pregnant, planning a pregnancy, lactating, or not using a medically acceptable form of birth control