A Study Comparing the Efficacy of Pataday® Once Daily Relief Extra Strength to Flonase® Allergy Relief in Subjects With Allergic Conjunctivitis

A Single-Center, Randomized, Double-Masked, Parallel Study Comparing the Efficacy of Pataday® Once Daily Relief Extra Strength to Flonase® Allergy Relief in Reducing Ocular Itching in Subjects With Allergic Conjunctivitis

This is a single-center, randomized, double-masked, parallel study.

At Visit 1, subjects will sign the informed consent and an allergic skin test will be performed, if required. Each qualifying subject will undergo a bilateral conjunctival allergen challenge (Ora-CAC®) titration using an allergen they had a positive reaction to on their skin test. Subjects who elicit a positive reaction post-CAC will undergo the confirmation CAC at Visit 2 using the same allergen they qualified with at Visit 1.

For subjects who continue to qualify following the confirmation CAC, treatment will begin at Visit 3. Subjects will be randomized to receive the following treatment at a 1:1 ratio:

• Pataday® Once Daily Relief Extra Strength and Saline Nasal Spray (n = 30)
• Tears Naturale® II and Flonase® Allergy Relief (n = 30)

At Visit 3, subjects will receive in-office administration of the assigned treatment. A trained study technician will observe subjects self-administer one drop of the assigned eyedrop (Pataday® Once Daily Relief Extra Strength or Tears Naturale® II) bilaterally. Within 5 minutes of administration of the eyedrop, a trained study technician will observe the subject self-administer two sprays of the assigned nasal spray (Flonase® Allergy Relief or saline nasal spray) in each nostril. Subjects will then undergo CAC 15 minutes following administration of the assigned nasal spray. Subjects will be dispensed the assigned study treatment to be used once daily beginning the day after Visit 3 up until the day before Visit 4 (Day 2 through Day 14). Subjects will also be dispensed a diary to record their daily dosing.

At Visit 4a, subjects will receive in-office administration of the assigned treatment. A trained study technician will observe subjects self-administer one drop of the assigned eyedrop (Pataday® Once Daily Relief Extra Strength or Tears Naturale® II) bilaterally. Within 5 minutes of administration of the eyedrop, a trained study technician will observe the subject self-administer two sprays of the assigned nasal spray (Flonase® Allergy Relief or saline nasal spray) in each nostril. Subjects will then return the next day for Visit 4b and will undergo CAC 24 hours following administration of the assigned nasal spray at Visit 4a.

Inclusion Criteria:

1. Be at least 18 years of age at Visit 1 of either gender and any race;
2. Provide written informed consent and sign the HIPAA form;
3. Be willing and able to follow all instructions and attend all study visits;
4. Be able to self-administer eyedrops and nasal spray satisfactorily or have a caregiver at home routinely available for this purpose;
5. Have a history of ocular allergies and a positive skin test reaction to a seasonal (grass, ragweed, and/or tree pollen) or perennial (cat dander, dog dander, dust mites, cockroach) allergen as confirmed by an allergic skin test conducted at Visit 1 or within the last 24 months;
6. Be able and willing to avoid all disallowed medications for the appropriate washout period and during the study (see exclusion 6);
7. Be able and willing to discontinue wearing contact lenses for at least 72 hours prior to Visit 1 and during the study trial period;
8. (for females capable of becoming pregnant) agree to have urine pregnancy testing performed at screening (must be negative) and exit visit; must not be lactating; and must agree to use a medically acceptable form of birth control throughout the study duration. Women considered capable of becoming pregnant include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy);
9. Have a calculated best-corrected visual acuity of 0.7 logMAR or better in each eye as measured using an ETDRS chart;
10. Have a positive bilateral post-CAC reaction (defined as having scores of ≥2 ocular itching and ≥2 conjunctival redness) within 10 (±2) minutes of instillation of the last titration of allergen at Visit 1;
11. Have a positive bilateral post-CAC reaction (defined as having scores of ≥2 ocular itching and ≥2 conjunctival redness) for at least two out of the first three time points following the challenge at Visit 2.

Exclusion Criteria:

1. Have known contraindications or sensitivities to the use of the investigational product or any of its components;
2. 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, history of corneal transplantation or a diagnosis of dry eye);
3. Have had ocular surgical intervention within three (3) months prior to Visit 1 or during the study and/or a history of refractive surgery within the past six (6) months;
4. Have a known history of retinal detachment, diabetic retinopathy, or active retinal disease;
5. Have the presence of an active ocular infection (bacterial, viral, or fungal) or positive history of an ocular herpetic infection at any visit;
6. Use any of the following disallowed medications during the period indicated prior to Visit 1 and during the study:

7 Days

• systemic or ocular H1-antihistamine, H1-antihistamine/mast cell stabilizers, H1-antihistamine-vasoconstrictor drug combinations;

• decongestants;

• monoamine oxidase inhibitors

• all other topical ophthalmic preparations (including artificial tears)

• lid scrubs;

• topical prostaglandins or prostaglandin derivatives

• ocular, topical, or systemic nonsteroidal anti-inflammatory drugs (NSAIDs, including baby aspirin (81 mg)) 14 Days

• inhaled, ocular, topical, or systemic corticosteroids or mast cell stabilizers

• ritonavir or other potent cytochrome P450 3A4 inhibitors; 45 Days

• depo-corticosteroids; Note: Currently marketed over-the-counter anti-allergy eye drops (i.e. anti-histamine/vasoconstrictor combination products such as Visine®-A®) may be administered to subjects by trained study personnel at the end of Visits 1, 2 and 4b after all evaluations are completed.

  7. 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;

  8. Have received allergy immunotherapy within the last 2 years;

  9. Manifest signs or symptoms of clinically active allergic conjunctivitis in either eye at the start of Visits 1, 2, or 3 (defined as the presence of any itching or >1 [greater than 1] redness in any vessel bed);

  10. Have a history of glaucoma;

  11. Have planned surgery (ocular or systemic) during the trial period or within 30 days after;

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

  13. Be a female who is currently pregnant, planning a pregnancy, or lactating.