A Clinical Trial to Evaluate the Clinical Efficacy of Cyclosporine 0.1% (Ikervis®) for Moderate to Severe Dry Eye Patients. (IKE-03-SWITCHING)

Yonsei University

Status and phase: Unknown; Phase 4

Conditions: Moderate to Severe Dry Eye

Treatments: Drug: Cyclosporine 0.1% (Ikervis®) eye drop

Study type: Interventional

Funder types: Other

Identifiers

NCT04775303

4-2019-1156

Details and patient eligibility

About

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 treatment effects of the previous Cyclosporine 0.05% eye drop.

Full 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 evaluated at baseline, 4 weeks, 8 weeks, and 12 weeks.

Enrollment: 90 estimated patients

Sex: All

Ages: 19 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

experimental group

Experimental group

Description:

Cyclosporine 0.1% (Ikervis®) eye drop - one drop once daily

Treatment:

Drug: Cyclosporine 0.1% (Ikervis®) eye drop