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 @ 9:15 PM
Ignite Modification Date:
2025-12-24 @ 9:15 PM
NCT ID:
NCT06981104
Eligibility Criteria:
Inclusion Criteria:
1. 18-75 years old (including 18 and 75 years old), male or female;
2. Meets the diagnostic criteria for dry eye syndrome in China (2020) and is mild dry eye 1) Dry Eye Questionnaire (OSDI) score ≥ 13 points; 2) BUT ≤ 10 seconds or Schirmer I ≤ 5mm/5 minutes 3) Corneal staining positive ≤ 5 points.
3. At least one of OSDI, BUT, and Schirmer I meets the moderate standard OSDI ≥ 23 points; BUT\<5 seconds; Schirmer I \< 5mm/5min
4. The subjects themselves signed an informed consent form and voluntarily participated in this study.
Exclusion Criteria:
1. Women who are breastfeeding or pregnant, or men and women of childbearing age who are unable to use effective contraceptive methods during the study period;
2. Those who need to wear contact lenses during treatment;
3. Acute inflammation, infection, allergy, and trauma of the eyes;
4. There are obvious scars or keratinization on the eyelid margin;
5. Have undergone eye or eyelid surgery within the 6 months prior to enrollment;
6. Diagnosed with facial nerve paralysis or ocular nerve paralysis within 6 months prior to enrollment;
7. Currently using lacrimal duct embolization (permanent lacrimal plug or treatment with lacrimal plug within 6 months);
8. I am currently taking medication that may affect dry eye syndrome.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06981104
Study Brief:
Protocol Section:
NCT06981104