Assessment of Fluticasone Propionate on Ocular Allergy Symptoms

Inclusion Criteria

• Participants with good general health (in the opinion of the investigator) with no clinically significant and relevant abnormalities of medical history
• Participants with diagnosis of seasonal allergic rhinitis
• A clinical history (written or verbal confirmation) of allergic rhinitis with the seasonal onset and offset of nasal and ocular allergy symptoms during each of the last 2 mountain cedar pollen allergy seasons.
• A positive skin test reaction to (at least) the relevant allergen, mountain cedar pollen, as determined by the skin pricks method performed within 12 months of Visit 1).
• Participants with allergic rhinitis symptom of at least moderate severity for randomization:
• An iTOSS of ≥ 4 and an iNCSS of ≥2 on the morning of randomization (Visit 3/Baseline).
• An averaged (rTOSS) of ≥ 4, and an averaged rNCSS of ≥2 for three of the five days during the placebo lead in
• Participant residing within a geographical environment where exposure to mountain cedar pollen is significant during the entire study period.
• Participant demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent/assent and has received a signed and dated copy of the informed consent/assent form. Children, ages 12 to 17 will be required to sign an assent form as part of the informed consent process.

Exclusion Criteria

• Participants with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
• Participants with nasal disorders like:
• injury or surgery to their nose that the investigator believes would interfere with participation in the study.
• previously diagnosed with a severe physical obstruction of the nose (e.g., deviated septum) that could affect the deposition of double-blind intranasal study drug.
• Rhinitis medicamentosa
• Participants who have historical or current evidence of clinically significant uncontrolled disease like asthma, cardiac arrhythmias, hypertension, diabetes mellitus, ocular herpes, glaucoma, hepatic or renal disease, malignancy etc.
• Presence of or symptoms of an active bacterial or viral infection.
• Participants who have conjunctivitis caused by an infectious agent.
• Participants with current, single eye or bilateral cataracts or participants who had cataract surgery within/less than 3 months