Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-25 @ 3:23 AM
NCT ID:
NCT02870205
Eligibility Criteria:
Inclusion Criteria:
* Males and non-pregnant females who are 12 years of age and older.
* Documented clinical history of SAR (for at least 2 years preceding the Screening Visit \[Visit 1\]) with exacerbations (clinical evidence of active symptoms) for the relevant seasonal allergen during the Fall or mountain cedar allergy seasons (e.g., ragweed or mountain cedar pollen)
* A 12-hour rTNSS ≥8 out of a possible 12 and a congestion score ≥2 for the AM assessment at the Screening Visit (Visit 1).
Exclusion Criteria:
* Pregnant or lactating women.
* History of anaphylaxis and/or other severe local reaction(s) to skin testing.
* History of positive test for HIV, Hepatitis B or Hepatitis C infection.
* Documented evidence of acute or significant chronic sinusitis or chronic purulent postnasal drip.
* Subjects with an active pulmonary disorder or infection.
* Subjects with posterior subcapsular cataracts or glaucoma
* Plans to travel outside the known pollen area for the investigational site for 24 hours or longer during the last 7 days of the run-in period.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT02870205
Study Brief:
Protocol Section:
NCT02870205