Effectiveness of PR013 Topical Ophthalmic Drops Compared to Vehicle for the Treatment of Allergic Conjunctivitis

A Multi-Center, Double-Masked, Randomized, Phase 2 Evaluation of the Effectiveness of PR013
Topical Ophthalmic Drops (0.045% and 0.06%) Compared to Vehicle of PR013 Topical Ophthalmic
Drops for the Treatment of Allergic Conjunctivitis Using a Modified Conjunctival Allergen
Challenge Model (Ora-CAC®)

Inclusion Criteria:

- be at least 10 years of age of either sex and any race

- have a positive history of ocular allergies and a positive skin test reaction to a
perennial allergen (cat dander, dog dander, dust mites, cockroaches) and a seasonal
allergen (trees, grasses, and/or ragweed) as confirmed by an allergic skin test within
the past 24 months.

- have a calculated visual acuity of 0.7 logMAR or better in each eye as measured using
an Early Treatment Diabetic Retinopathy Study (ETDRS) chart

Exclusion Criteria:

- have known contraindications or sensitivities to the use of the investigational
product or any of its components

- have any ocular condition that, in the opinion of the investigator, could affect the
subject's safety or trial parameters (including but not limited to narrow angle
glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis,
pterygium or a diagnosis of dry eye)

- have had ocular surgical intervention within 3 months prior to Visit 1 or during the
study and/or a history of refractive surgery within the past 6 months

- have a known history of retinal detachment, diabetic retinopathy, or active retinal
disease

- have the presence of an active ocular infection (bacterial, viral or fungal) or
positive history of an ocular herpetic infection at any visit

- use any of the disallowed medications* during the period indicated prior to Visit 1
and during the study

- have any significant illness (e.g. any autoimmune disease requiring therapy, severe
cardiovascular disease [including arrhythmias] the investigator feels could be
expected to interfere with the subject's health or with the study parameters and/or
put the subject at any unnecessary risk (includes but is not limited to: poorly
controlled hypertension or poorly controlled diabetes, a history of status
asthmaticus, organ transplants, a known history of persistent moderate or severe
asthma, or a known history of moderate to severe allergic asthmatic reactions to any
of the study allergens;

- have planned surgery (ocular or systemic) during the trial period or within 30 days
after;

- have used an investigational drug or medical device within 30 days of the study or be
concurrently enrolled in another investigational product trial;

- be a female who is currently pregnant, planning a pregnancy, or lactating