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 @ 2:48 AM
Ignite Modification Date:
2025-12-25 @ 2:48 AM
NCT ID:
NCT06360133
Eligibility Criteria:
Inclusion Criteria:
* Provided written informed consent prior to any study-related procedures.
* Are between 30 and 80 years of age.
* Have a history of dry eye disease in both eyes.
* Have been using artificial tears within 30 days of the screening visit
* Have an Eye dryness score ≥50 (0-100 point VAS)
* Have ongoing dry eye disease in the same eye or both eyes, as defined by all of the following criteria in the study eye and the same eye at Visit 1 and Visit 2: 1) total CFS (tCFS) score ≥6; 2) any subregion CS score ≥2.5; 3) Schirmer score (without anesthesia) ≥1 and ≤7 mm/5 min.
* Have a BCVA in the study eye of ≥4.3 (Standard for Logarithmic Visual Acuity Charts, 5-mark record).
Exclusion Criteria:
* Have a known hypersensitivity or contraindication to the IP or components of IP.
* Have history of uncontrolled glaucoma, IOP over 21 mmHg in either eye at the screening visit or are being treated with eye drops for glaucoma in the study eye. Or the subject has had laser or surgery for glaucoma in the study eye within 90 days of the study.
* Woman of childbearing potential (WOCP) who are pregnant, lactating, or preparing for pregnant.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
80 Years
Study:
NCT06360133
Study Brief:
Protocol Section:
NCT06360133