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 @ 12:50 PM
Ignite Modification Date:
2025-12-24 @ 12:50 PM
NCT ID:
NCT05456061
Eligibility Criteria:
Inclusion Criteria:
1. presence of one or more subjective symptoms of DED, including eye dryness, foreign body sensation, irritation, burning, blurred vision, and pain.
2. tear meniscus height (TMH) of \<200 µm for aqueous deficiency measured using Keratograph 5M® (Oculus Optikgeräte GmbH, Wetzlar, Germany).
3. evidence of corneal and/or conjunctival damage on slit-lamp biomicroscopy with fluorescein staining.
Exclusion Criteria:
1. acute and chronic ocular surface diseases that affect DED, including infection, allergy, and autoimmune disease, and that interfere with tear interferometric measurements, such as corneal opacity and pterygium, were excluded.
2. a history of the use of contact lens, known systemic diseases such as Sjögren's syndrome, Stevens-Johnson syndrome, and ocular graft-versus-host disease.
3. any medical/surgical history related to tear production and tear function except that in the study protocol were excluded.
4. Hypersecretory meibomian gland dysfunction (MGD)
* When both eyes of a patient could be included, an eye with the lower TMH was selected.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT05456061
Study Brief:
Protocol Section:
NCT05456061