Last updated: February 25, 2021
Sponsor: Yonsei University
Overall Status: Active - Recruiting
Phase
4
Condition
Sjogren's Syndrome
Dry Eye Disease
Eyelid Inflammation
Treatment
N/AClinical Study ID
NCT04775303
4-2019-1156
Ages 19-79 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age between 19 and less than 80 years old
- A patient with moderate or severe dry eye who has used Cyclosporine 0.05% eye drop formore than 3 months and has no or insufficient treatment effect
- No or insufficient treatment effect should meet the following criteria through testsused to diagnose dry eyes
- A SANDE (Symptom Assessment in Dry Eye) score of 40 or more on the severity andfrequency 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 blurredvision.
- Use of diquafosol tetrasodium 3% eye drop and/or artificial tears are allowedwith no change of products and dosage throughout the trial period
- A person who voluntarily agrees in writing to participate in this clinical trial
Exclusion
Exclusion Criteria:
- Use of eye drops within four weeks of the consent date such as steroids, glaucoma,allergies and anti-inflammatory drugs, etc.
- Systematic steroid within four weeks of the consent date
- Patients with pterygium
- Start new immunosuppressive drugs or change in dosage that can affect immune functionwithin four weeks of the consent date due to an unregulated systemic disease.
- Severe MGD patient
- Ophthalmic surgery (including Lasik/Lasek) and trauma in eyes within the last threemonths
- Wearing contact lenses during a clinical trial period
- Planning an eye surgery (including Lasik/Lasek) during the clinical trial period
- Hypersensitivity to the clinical trial drug
- Active or suspected eye infections
- Pregnant or breastfeeding, or women planning to become pregnant
- Participation in other clinical trials within three months
- Any person who is deemed unfit for clinical trial by a investigator
Study Design
Total Participants: 90
Study Start date:
September 25, 2020
Estimated Completion Date:
January 31, 2022
Study Description
Connect with a study center
Severance Hospital
Seoul,
Korea, Republic ofActive - Recruiting
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