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 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT06291194
Eligibility Criteria:
Inclusion Criteria:
* Male and Female who over 19 years old
* Moderate to Severe Dry Eye Disease Patients
* Must meet all criteria listed below at least in one eye or both eyes.
1. TCSS (National eye institute (NEI) scale)≥ 4
2. Ocular discomfort score (ODS) ≥ 3
3. Schirmer test(without anesthesia) ≤ 10mm in 5 mins
4. Tear break-up time ≤ 6 secs
* Written informed consent to participate in the trial
Exclusion Criteria:
* Those who have clinically significant eye disease not related to dry eye syndrome
* Those who have worn contact lenses before 1week Screening visit or have to wear contact lenses or need to wear contact lenses during study period
* Those who have medical history with intraocular surgery 12months before screening visit
* Use of corticosteroid, beta blocker and anticholinergic agent within 4 weeks
* Participation in other studies within 4weeks of screening visit
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT06291194
Study Brief:
Protocol Section:
NCT06291194