Status:
UNKNOWN
A Clinical Trial to Evaluate the Clinical Efficacy of Cyclosporine 0.1% (Ikervis®) for Moderate to Severe Dry Eye Patients. (IKE-03-SWITCHING)
Lead Sponsor:
Yonsei University
Conditions:
Moderate to Severe Dry Eye
Eligibility:
All Genders
19-79 years
Phase:
PHASE4
Brief Summary
A clinical trial to evaluate the efficacy and safety of Cyclosporine 0.1% (Ikervis®) for moderate to severe dry eye patients who changed to Cyclosporine 0.1% eye drop(Ikervis®) due to lack of treatmen...
Detailed Description
Eligible patients who agree to participate in the clinical trial in writing will be administered Cyclosporine 0.1% eye drop(Ikervis®) one drop once daily for 12 weeks. Efficacy and safety will be eval...
Eligibility Criteria
Inclusion
- 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 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
- A person who voluntarily agrees in writing to participate in this clinical trial
Exclusion
- 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 function within 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 three months
- 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
Key Trial Info
Start Date :
September 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2022
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04775303
Start Date
September 25 2020
End Date
January 1 2022
Last Update
March 1 2021
Active Locations (1)
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1
Severance Hospital
Seoul, South Korea