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 @ 7:09 PM
Ignite Modification Date:
2025-12-24 @ 7:09 PM
NCT ID:
NCT04775303
Eligibility Criteria:
Inclusion Criteria:
1. Age between 19 and less than 80 years old
2. A patient with moderate or severe dry eye who has used Cyclosporine 0.05% eye drop for more than 3 months and has no or insufficient treatment effect
\- No or insufficient treatment effect should meet the following criteria through tests used to diagnose dry eyes
* A SANDE (Symptom Assessment in Dry Eye) score of 40 or more on the severity and frequency of dry eye symptoms.
* Cornea staining score (NEI scale) 3 or more points
* Tear Break Up Time(TBUT) 10 seconds or less
* Tear volume tested by Tear Meniscometry less than 5mm
* Has One or more of the dry eye symptoms; stinging, irritating, itching or blurred vision.
* Use of diquafosol tetrasodium 3% eye drop and/or artificial tears are allowed with no change of products and dosage throughout the trial period
3. A person who voluntarily agrees in writing to participate in this clinical trial
Exclusion Criteria:
1. Use of eye drops within four weeks of the consent date such as steroids, glaucoma, allergies and anti-inflammatory drugs, etc.
2. Systematic steroid within four weeks of the consent date
3. Patients with pterygium
4. Start new immunosuppressive drugs or change in dosage that can affect immune function within four weeks of the consent date due to an unregulated systemic disease.
5. Severe MGD patient
6. Ophthalmic surgery (including Lasik/Lasek) and trauma in eyes within the last three months
7. Wearing contact lenses during a clinical trial period
8. Planning an eye surgery (including Lasik/Lasek) during the clinical trial period
9. Hypersensitivity to the clinical trial drug
10. Active or suspected eye infections
11. Pregnant or breastfeeding, or women planning to become pregnant
12. Participation in other clinical trials within three months
13. Any person who is deemed unfit for clinical trial by a investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
79 Years
Study:
NCT04775303
Study Brief:
Protocol Section:
NCT04775303