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 @ 11:11 PM
Ignite Modification Date:
2025-12-24 @ 11:11 PM
NCT ID:
NCT04819269
Eligibility Criteria:
Inclusion Criteria:
* Subject is a male or a female aged ≥ 18 years
* Have given their written consent to participate in the study
* Use of artificial tears (AT), autologous serum or specific dry eye medications during the last 6 months prior to the selection
* Willing to not use AT or autologous serum for the study duration
* VAS scale for Dry Eye Symptom Score ≥ 40
* Total CFS ≥ 5
* Schirmer's test with anesthesia \< 10 mm/5min
* Patients with Sjögren Syndrome
Exclusion Criteria:
* Any concomitant treatment or prior ocular procedure or surgery, or alteration of the dose of systemic medications at the time of entry into the study
* Use of contact lenses during the study
* Significant Eye diseases according to investigator's opinion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04819269
Study Brief:
Protocol Section:
NCT04819269