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 @ 12:39 PM
Ignite Modification Date:
2025-12-24 @ 12:39 PM
NCT ID:
NCT06525961
Eligibility Criteria:
Inclusion Criteria:
Each patient must meet all the following criteria to be enrolled in this study:
1. Provided informed consent, approved by the Institutional Review Board (IRB), to participate in the study.
2. Reported use of artificial tears for DED within 30 days of Visit 1.
3. Ocular Surface Disease Index (OSDI) ≥ 23 (with no more than 3 N/A in the answers).
4. Anesthetized Schirmer Test Score ≤ 10 mm/5 min in at least one eye.
Exclusion Criteria:
Patients who meet any of the following criteria will be excluded from the study:
1. Used extranasal or intranasal neurostimulator within 30 days of Visit 1.
2. Participation in any clinical trial with an investigational drug or device within 30 days of Visit 1.
3. In the opinion of the investigator, any condition that could impair study participation/ocular evaluation or the potential risks of participation outweigh the potential benefits.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06525961
Study Brief:
Protocol Section:
NCT06525961