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 @ 3:24 AM
Ignite Modification Date:
2025-12-25 @ 3:24 AM
NCT ID:
NCT01454505
Eligibility Criteria:
Stage A Inclusion Criteria:
* Willing and able to give written informed consent.
* In good health in the opinion of an appropriately qualified physician.
* Females of childbearing potential (who are not at least 1 year post-menopausal or surgically sterilized) must have a negative urine pregnancy test at Visit 1, and must not be nursing or plan to become pregnant during the course of the study.
* Other protocol-defined inclusion criteria may apply.
Stage B Inclusion Criteria:
* History of non-recalcitrant seasonal allergic rhinitis during the fall allergy season.
* Allergy to short ragweed allergen, defined by positive skin prick test for short ragweed allergen within the 12 months prior to Visit 1.
* Be in good health in the opinion of an appropriately qualified physician.
* Females of childbearing potential (who are not at least 1 year post-menopausal or surgically sterilized) must have negative urine pregnancy test at Visit 1, and must not be nursing or plan to become pregnant during the course of the study.
* Other protocol-defined inclusion criteria may apply.
Stage A Exclusion Criteria:
* Hypersensitivity to the study drug or any component of the test articles, including benzalkonium chloride.
* Using any prescription or non-prescription systemic or topical medications, vitamins or dietary supplements within 14 days prior to the check-in day (except for acetaminophen at doses of \< 2 grams/day or topical, hormonal-oral, implantable or injectable contraceptives).
* Current or recent history of severe, unstable, or uncontrolled conditions based upon a review of medical history and/or physical examination.
* Any nasal disorder that could preclude safe administration of study medication and/or interfere with the evaluation of the study medication.
* History of HIV, hepatitis B or active hepatitis A as determined by medical history and/or by serology at the Screening Visit.
* Any screening clinical laboratory result (hematology, serum chemistry or urinalysis) outside the normal range that is clinically relevant in the opinion of an appropriately qualified physician and/or Alcon physician.
* Participation in any investigational study within 30 days of entry into this study or concomitantly with this study.
* Other protocol-defined exclusion criteria may apply.
Stage B Exclusion Criteria:
* Any screening clinical laboratory result (hematology, serum chemistry or urinalysis) outside the normal range that is clinically relevant in the opinion of an appropriately qualified physician and/or Alcon physician.
* Using any prescription or non-prescription systemic or topical medications, vitamins or dietary supplements within 14 days prior to the check-in day (except for acetaminophen at doses of \< 2 grams/day or topical, hormonal-oral, implantable or injectable contraceptives).
* History of HIV, hepatitis B or C or active hepatitis A as determined by medical history and/or by serology at the Screening Visit.
* Any nasal disorder that could preclude safe administration of study medication and/or interfere with the evaluation of the study medication.
* Confirmed diagnosis of chronic rhinosinusitis within 12 months of Visit.
* Confirmed diagnosis of severe rhinitis or rhinosinusitis prior to Visit 1 that, in the opinion of the Investigator, would preclude safe subject participation in the study.
* Current or recent history of any severe, unstable, or uncontrolled condition that, in the opinion of the Investigator, would preclude safe participation in the study.
* Participation in any investigational study within 30 days of entry into this study or concomitantly with this study.
* Other protocol-defined exclusion criteria may apply.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01454505
Study Brief:
Protocol Section:
NCT01454505