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

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/A

Clinical Study ID

NCT04775303
4-2019-1156
  • Ages 19-79
  • All Genders

Study 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 treatment effects of the previous Cyclosporine 0.05% eye drop.

Eligibility Criteria

Inclusion

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 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
  1. A person who voluntarily agrees in writing to participate in this clinical trial

Exclusion

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 functionwithin 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 threemonths
  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

Study Design

Total Participants: 90
Study Start date:
September 25, 2020
Estimated Completion Date:
January 31, 2022

Study 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.

Connect with a study center

  • Severance Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

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