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:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-24 @ 5:24 PM
NCT ID:
NCT05264350
Eligibility Criteria:
Inclusion Criteria:
* Signed Informed Consent Form.
* Adult males and females ≥ 18 years old.
* Score of at least 10 as indication for application of moistening nasal sprays per investigator judgement, confirmed with a total Rhinitis Sicca Symptom Score (sensation of dry nose, nasal obstruction, crusting, itching/sneezing attacks, pain in the nose, runny nose, thick nasal discharge, dry throat, impairment of smell and impairment of sleep) using a 5-point severity scale (0=none, 1=mild, 2=moderate, 3=strong, and 4 = very strong.
* Able to use the device independently.
Exclusion Criteria:
* Antiallergy drugs and rhinitis medication, including rescue medication for symptom relief and anti-hyperactivity last week.
* Pregnancy or lactation at time of investigation participation.
* Physical or mental impairment affecting subjects' ability to use the device, per investigator judgement.
* Person not suitable for the investigation according to the investigator judgement.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05264350
Study Brief:
Protocol Section:
NCT05264350