Assessment of Fluticasone Propionate on Ocular Allergy Symptoms
Condition: Allergic Rhinitis; Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: Fluticasone propionate; Placebo
Intervention description: Nasal spray formulation (200 mcg/day); Vehicle for Fluticasone propionate aqueous nasal spray
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 3
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 626.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is designed to investigate the efficacy of fluticasone propionate (FP) on ocular
      symptoms associated with allergic rhinitis (AR).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participants with good general health (in the opinion of the investigator) with no
             clinically significant and relevant abnormalities of medical history

          2. Participants with diagnosis of seasonal allergic rhinitis

               1. 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.

               2. 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).

          3. Participants with allergic rhinitis symptom of at least moderate severity for
             randomization:

               1. An iTOSS of ≥ 4 and an iNCSS of ≥2 on the morning of randomization (Visit
                  3/Baseline).

               2. An averaged (rTOSS) of ≥ 4, and an averaged rNCSS of ≥2 for three of the five
                  days during the placebo lead in

          4. Participant residing within a geographical environment where exposure to mountain
             cedar pollen is significant during the entire study period.

          5. 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:

          1. Participants with known or suspected intolerance or hypersensitivity to the study
             materials (or closely related compounds) or any of their stated ingredients.

          2. Participants with nasal disorders like:

               1. injury or surgery to their nose that the investigator believes would interfere
                  with participation in the study.

               2. 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.

               3. Rhinitis medicamentosa

          3. 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.

          4. Presence of or symptoms of an active bacterial or viral infection.

          5. Participants who have conjunctivitis caused by an infectious agent.

          6. Participants with current, single eye or bilateral cataracts or participants who had
             cataract surgery within/less than 3 months